Safety of Vaccines Used for Routine Immunization in the United States: An Update

Project Summary Title and Description

Title
Safety of Vaccines Used for Routine Immunization in the United States: An Update
Description
Objective. To conduct a systematic review of the literature on the safety of vaccines recommended for routine immunization in the United States, updating the 2014 Agency for Healthcare Research and Quality (AHRQ) report on the topic. Data sources. We searched MEDLINE®, Embase®, CINAHL®, Cochrane CENTRAL, Web of Science, and Scopus through November 9, 2020, building on the prior 2014 report; reviewed existing reviews, trial registries, and supplemental material submitted to AHRQ; and consulted with experts. Review methods. This report addressed three Key Questions (KQs) on the safety of vaccines currently in use in the United States and included in the Centers for Disease Control and Prevention’s (CDC) recommended immunization schedules for adults (KQ1), children and adolescents (KQ2), and pregnant women (KQ3). The systematic review was supported by a Technical Expert Panel that identified key adverse events of particular concern. Two reviewers independently screened publications; data were extracted by an experienced subject matter expert. Studies of vaccines that used a comparator and reported the presence or absence of adverse events were eligible. We documented observed rates and assessed the relative risks for key adverse events. We assessed the strength of evidence (SoE) across the existing findings from the prior 2014 report and the new evidence from this update. The systematic review is registered in PROSPERO (CRD42020180089). Results. A large body of evidence is available to evaluate adverse events following vaccination. Of 56,608 reviewed citations, 189 studies met inclusion criteria for this update, adding to data in the prior 2014 report, for a total of 338 included studies reported in 518 publications. Regarding vaccines recommended for adults (KQ1), we found either no new evidence of increased risk for key adverse events with varied SoE or insufficient evidence in this update, including for newer vaccines such as recombinant influenza vaccine, adjuvanted inactivated influenza vaccine, and recombinant adjuvanted zoster vaccine. The prior 2014 report noted a signal for anaphylaxis for hepatitis B vaccines in adults with yeast allergy and for tetanus, diphtheria, and acellular pertussis vaccines. Regarding vaccines recommended for children and adolescents (KQ2), we found either no new evidence of increased risk for key adverse events with varied SoE or insufficient evidence, including for newer vaccines such as 9-valent human papillomavirus vaccine and meningococcal B vaccine. The prior 2014 report noted signals for rare adverse events—such as anaphylaxis, idiopathic thrombocytopenic purpura, and febrile seizures—with some childhood vaccines. Regarding vaccines recommended for pregnant women (KQ3), we found no evidence of increased risk for key adverse events with varied SoE among either pregnant women or their infants following administration of tetanus, diphtheria, and acellular pertussis vaccines during pregnancy. Conclusion. Across this large body of research, we found no new evidence of increased risk since the prior 2014 report for key adverse events following administration of vaccines that are routinely recommended. Signals from the prior report remain unchanged for rare adverse events, which include anaphylaxis in adults and children, and febrile seizures and idiopathic thrombocytopenic purpura in children. There is no evidence of increased risk of adverse events for vaccines currently recommended in pregnant women. There remains insufficient evidence to draw conclusions about some rare potential adverse events.
Attribution
N/A
Authors of Report
N/A
Methodology description
Systematic Review
PROSPERO
CRD42020180089
DOI
N/A
Notes
Report can be found here: https://pubmed.ncbi.nlm.nih.gov/34279864/ and https://effectivehealthcare.ahrq.gov/products/safety-vaccines/research Data was entered into this project prospectively
Funding Source
Agency for Healthcare Research and Quality

Key Questions

1. Key Question 1: What is the evidence that vaccines included in the immunization schedule recommended for adults in the United States (https://www.cdc.gov/vaccines/schedules/hcp/imz/adult.html) are safe in the short term (within 42 days following immunization) or long term (>42 days after immunization)?
2. Key Question 2: What is the evidence that vaccines included in the immunization schedules recommended for children and adolescents in the United States (https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html) are safe in the short term (within 42 days following immunization) or long term (>42 days after immunization)?
3. Key Question 3: What is the evidence that vaccines recommended for pregnant women, in the United States are safe in the short term (within 42 days following immunization) or long term (>42 days after immunization) for both the woman and her fetus/infant?

Associated Extraction Forms

Associated Studies (each link opens a new tab)

TitleAuthorsYear
Safety and Efficacy of HEPLISAV Hepatitis B Virus Vaccine Compared With Engerix-B VaccineCorporation, Dynavax Technologies2006
Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV, Compared to Engerix-B VaccineCorporation Dynavax Technologies2015
Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared to a licensed hepatitis B vaccine in healthy adults 40-70 years of ageWilliam L. Heyward; Michael Kyle; Joseph Blumenau; Matthew Davis; Keith Reisinger; Martin L. Kabongo; Sean Bennett; Robert S. Janssen; Hamid Namini; J. Tyler Martin2013
Vaccines and the risk of multiple sclerosis and other central nervous system demyelinating diseasesAnnette Langer-Gould; Lei Qian; Sara Y. Tartof; Sonu M. Brara; Steve J. Jacobsen; Brandon E. Beaber; Lina S. Sy; Chun Chao; Rulin Hechter; Hung Fu Tseng2014
Immunogenicity and safety of a cell culture-based quadrivalent influenza vaccine in adults: A Phase III, double-blind, multicenter, randomized, non-inferiority studyStephan Bart; Kevin Cannon; Darrell Herrington; Richard Mills; Eduardo Forleo-Neto; Kelly Lindert; Ahmed Abdul Mateen2016
Immunogenicity and safety of quadrivalent versus trivalent inactivated influenza vaccine: a randomized, controlled trial in adultsJ. Beran; M. Peeters; W. Dewe; J. Raupachova; L. Hobzova; J. M. Devaster2013
Safety and immunogenicity of high-dose quadrivalent influenza vaccine in adults >=65years of age: A phase 3 randomized clinical trialLee-Jah Chang; Ya Meng; Helene Janosczyk; Victoria Landolfi; H. Keipp Talbot; Q. H. D. Study Group2019
Safety and immunogenicity of a quadrivalent inactivated influenza vaccine compared to licensed trivalent inactivated influenza vaccines in adultsD. P. Greenberg; C. A. Robertson; M. J. Noss; M. M. Blatter; R. Biedenbender; M. D. Decker2013
Safety and immunogenicity of a quadrivalent influenza vaccine in adults 65 y of age and olderDavid P. Greenberg; Corwin A. Robertson; H. Keipp Talbot; Michael D. Decker2017
Immunogenicity, reactogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine: a phase III, randomized trial in adults aged >=18 yearsDorothee Kieninger; Eric Sheldon; Wen-Yuan Lin; Chong-Jen Yu; Jose M. Bayas; Julian J. Gabor; Meral Esen; Jose Luis Fernandez Roure; Silvia Narejos Perez; Carmen Alvarez Sanchez; Yang Feng; Carine Claeys; Mathieu Peeters; Bruce L. Innis; Varsha Jain2013
Immunogenicity, reactogenicity, and safety of inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine in healthy adults aged >=18 years: a phase III, randomized trialJuan Carlos Tinoco; Noris Pavia-Ruz; Aurelio Cruz-Valdez; Carlos Aranza Doniz; Vijayalakshmi Chandrasekaran; Walthere Dewe; Aixue Liu; Bruce L. Innis; Varsha K. Jain2014
Immunogenicity and safety of a quadrivalent inactivated influenza vaccine compared with two trivalent inactivated influenza vaccines containing alternate B strains in adults: A phase 3, randomized noninferiority studyJohn T. Treanor; Frank R. Albano; Daphne C. Sawlwin; Alison Graves Jones; Jolanta Airey; Neil Formica; Vince Matassa; Jane Leong2017
Immunogenicity and safety of MF59-adjuvanted quadrivalent influenza vaccine versus standard and alternate B strain MF59-adjuvanted trivalent influenza vaccines in older adultsBrandon Essink; Carlos Fierro; Jeffrey Rosen; Amparo L. Figueroa; Bin Zhang; Carole Verhoeven; Jonathan Edelman; Igor Smolenov2020
Comparison of the safety and immunogenicity of an MF59-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjectsSharon E. Frey; Mari Rose Aplasca-De Los Reyes; Humberto Reynales; Nancy Nazaire Bermal; Uwe Nicolay; Vas Narasimhan; Eduardo Forleo-Neto; Ashwani Kumar Arora2014
Surveillance for Guillain-Barre syndrome after influenza vaccination among U.S. Medicare beneficiaries during the 2017-2018 seasonPerez-Vilar, Silvia; Wernecke, Michael; Arya, Deepa; Lo, An-Chi; Lufkin, Bradley; Hu, Mao; Chu, Steve; MaCurdy, Thomas E.; Kelman, Jeffrey; Forshee, Richard A.2019
Effectiveness of MF59-adjuvanted subunit influenza vaccine in preventing hospitalisations for cardiovascular disease, cerebrovascular disease and pneumonia in the elderlyJ. Puig-Barbera; J. Diez-Domingo; A. B. Varea; G. S. Chavarri; J. A. L. Rodrigo; S. P. Hoyos; D. G. Vidal2007
Immunogenicity and safety of concomitant MF59-adjuvanted influenza vaccine and 23-valent pneumococcal polysaccharide vaccine administration in older adultsJoon Young Song; Hee Jin Cheong; T. F. Tsai; Hyun-Ah Chang; Min Joo Choi; Ji Ho Jeon; Seong Hee Kang; Eun Ju Jeong; Ji Yun Noh; Woo Joo Kim2015
Safety of MF59-adjuvanted influenza vaccination in the elderly: results of a comparative study of MF59-adjuvanted vaccine versus nonadjuvanted influenza vaccine in northern ItalyMarco Villa; Steven Black; Nicola Groth; Kenneth J. Rothman; Giovanni Apolone; Noel S. Weiss; Ivana Aquino; Liana Boldori; Fausta Caramaschi; Antonio Gattinoni; Giancarlo Malchiodi; Antonio Crucitti; Giovanni Della Cioppa; Elio Scarpini; Domenico Mavilio; Salvatore Mannino2013
A randomized, double-blind noninferiority study of quadrivalent live attenuated influenza vaccine in adultsS. L. Block; T. Yi; E. Sheldon; F. Dubovsky; J. Falloon2011
Comparative Immunogenicity of Several Enhanced Influenza Vaccine Options for Older Adults: A Randomized, Controlled TrialBenjamin J. Cowling; Ranawaka A. P. M. Perera; Sophie A. Valkenburg; Nancy H. L. Leung; A. Danielle Iuliano; Yat Hung Tam; Jennifer H. F. Wong; Vicky J. Fang; Athena P. Y. Li; Hau Chi So; Dennis K. M. Ip; Eduardo Azziz-Baumgartner; Alicia M. Fry; Min Z. Levine; Shivaprakash Gangappa; Suryaprakash Sambhara; Ian G. Barr; Danuta M. Skowronski; J. S. Malik Peiris; Mark G. Thompson2019
Efficacy of Recombinant Influenza Vaccine in Adults 50 Years of Age or OlderLisa M. Dunkle; Ruvim Izikson; Peter Patriarca; Karen L. Goldenthal; Derek Muse; Janice Callahan; Manon M. J. Cox; P. S. C. Study Team2017
Safety and Immunogenicity of Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose, Influenza Vaccines, 2018-2019 FormulationsSanofi Company Sanofi Pasteur,Sanofi2018
Safety and immunogenicity of typhoid fever and yellow fever vaccines when administered concomitantly with quadrivalent meningococcal ACWY glycoconjugate vaccine in healthy adultsMartin Alberer; Gerd Burchard; Tomas Jelinek; Emil Reisinger; Jiri Beran; Lucie Cerna Hlavata; Eduardo Forleo-Neto; Alemnew F. Dagnew; Ashwani K. Arora2015
Immunogenicity and safety of concomitant administration of a combined hepatitis A/B vaccine and a quadrivalent meningococcal conjugate vaccine in healthy adultsMartin Alberer; Gerd Burchard; Tomas Jelinek; Emil C. Reisinger; Seetha Meyer; Eduardo Forleo-Neto; Alemnew F. Dagnew; Ashwani Kumar Arora2015
Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in >/=56-year-olds: A Phase III randomized studyEsteves-Jaramillo, A.; Koehler, T.; Jeanfreau, R.; Neveu, D.; Jordanov, E.; Singh Dhingra, M.2020
Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adults 56 years of age and older: a Phase II randomized studyKirstein, J.; Pina, M.; Pan, J.; Jordanov, E.; Dhingra, M. S.2020
Polysaccharide conjugate vaccine against pneumococcal pneumonia in adultsMarc J. M. Bonten; Susanne M. Huijts; Marieke Bolkenbaas; Chris Webber; Scott Patterson; Samantha Gault; Cornelis H. van Werkhoven; Anna M. M. van Deursen; Elisabeth A. M. Sanders; Theo J. M. Verheij; Michael Patton; Anne McDonough; Anita Moradoghli-Haftvani; Helen Smith; Tracey Mellelieu; Michael W. Pride; Graham Crowther; Beate Schmoele-Thoma; Daniel A. Scott; Kathrin U. Jansen; Rita Lobatto; Bas Oosterman; Nils Visser; Esther Caspers; Andre Smorenburg; Emilio A. Emini; William C. Gruber; Diederick E. Grobbee2015
A randomized, controlled trial comparing the immunogenecity and safety of a 23-valent pneumococcal polysaccharide vaccination to a repeated dose 13-valent pneumococcal conjugate vaccination in kidney transplant recipientsEriksson, M.; Kyhty, H.; Saha, H.; Lahdenkari, M.; Koskinen, P.; Mkisalo, H.; Anttila, V. J.2020
Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adultsR. W. Frenck, Jr.; A. Gurtman, J. Rubino; W. Smith, M. van Cleeff; D. Jayawardene, P. C. Giardina; E. A. Emini, W. C. Gruber; D. A. Scott, and B. Schmole-Thoma2012
Sequential administration of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naive adults 60-64 years of ageRichard N. Greenberg; Alejandra Gurtman; Robert W. Frenck; Cynthia Strout; Kathrin U. Jansen; James Trammel; Daniel A. Scott; Emilio A. Emini; William C. Gruber; Beate Schmoele-Thoma2014
Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine compared to a 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naive adultsLisa A. Jackson; Alejandra Gurtman; Martin van Cleeff; Kathrin U. Jansen; Deepthi Jayawardene; Carmel Devlin; Daniel A. Scott; Emilio A. Emini; William C. Gruber; Beate Schmoele-Thoma2013
Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine formulations with and without aluminum phosphate and comparison of the formulation of choice with 23-valent pneumococcal polysaccharide vaccine in elderly adults: a randomized open-label trialChristine Juergens; Pierre J. T. de Villiers; Keymanthri Moodley; Deepthi Jayawardene; Kathrin U. Jansen; Daniel A. Scott; Emilio A. Emini; William C. Gruber; Beate Schmoele-Thoma2014
Immunosuppressive drugs impairs antibody response of the polysaccharide and conjugated pneumococcal vaccines in patients with Crohn's diseaseBjorn Kantso; Sofie Ingdam Halkjaer; Ole Ostergaard Thomsen; Erika Belard; Ida Benedikte Gottschalck; Charlotte Svaerke Jorgensen; Karen A. Krogfelt; Hans-Christian Slotved; Helene Ingels; Andreas Munk Petersen2015
Immunogenicity and Safety of the 13-Valent Pneumococcal Conjugate Vaccine versus the 23-Valent Polysaccharide Vaccine in Unvaccinated HIV-Infected Adults: A Pilot, Prospective Controlled StudyFrancesca Lombardi; Simone Belmonti; Massimiliano Fabbiani; Matteo Morandi; Barbara Rossetti; Giacinta Tordini; Roberto Cauda; Andrea De Luca; Simona Di Giambenedetto; Francesca Montagnani2016
Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in AdultsPfizer2007
A randomized, double-blind trial to evaluate immunogenicity and safety of 13-valent pneumococcal conjugate vaccine given concomitantly with trivalent influenza vaccine in adults aged >=65 yearsT. F. Schwarz; J. Flamaing; H. C. Rumke; J. Penzes; C. Juergens; A. Wenz; D. Jayawardene; P. Giardina; E. A. Emini; W. C. Gruber; B. Schmoele-Thoma2011
Comparison of immunogenicity and safety of an influenza vaccine administered concomitantly with a 13-valent pneumococcal conjugate vaccine or 23-valent polysaccharide pneumococcal vaccine in the elderlyY. B. Seo; W. S. Choi; J. Lee; J. Y. Song; H. J. Cheong; W. J. Kim2017
Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine compared to the 23-valent pneumococcal polysaccharide vaccine in elderly Japanese adultsMasanari Shiramoto; Ryuzo Hanada; Christine Juergens; Yasuko Shoji; Mizuki Yoshida; Barry Ballan; David Cooper; William C. Gruber; Daniel A. Scott; Beate Schmoele-Thoma2015
Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine and an MF59-adjuvanted influenza vaccine after concomitant vaccination in 60-year-old adultsSong, Joon Young; Cheong, Hee Jin; Hyun, Hak Jun; Seo, Yu Bin; Lee, Jacob; Wie, Seong-Heon; Choi, Min Joo; Choi, Won Suk; Noh, Ji Yun; Yun, Jae Won; Yun, Jin Gu; Kim, Woo Joo2017b
Immunogenicity and safety of a tetanus-diphtheria vaccine and a 13-valent pneumococcal conjugate vaccine after concomitant vaccination in >= 50-year-old adultsJoon Young Song; Hee Jin Cheong; Ji Yun Noh; Min Joo Choi; Jin Gu Yoon; Saem Na Lee; Seong Hui Kang; Eun Joo Jeong; Yu Mi Jo; Woo Joo Kim2018
Pneumococcal conjugate vaccine triggers a better immune response than pneumococcal polysaccharide vaccine in patients with chronic lymphocytic leukemia A randomized study by the Swedish CLL groupTobias Svensson; Magdalena Kattstrom; Ylva Hammarlund; Daniel Roth; P. O. Andersson; Magnus Svensson; Ingmar Nilsson; Lars Rombo; Honar Cherif; Eva Kimby2018
Coadministration of 13-valent pneumococcal conjugate and quadrivalent inactivated influenza vaccines in adults previously immunized with polysaccharide pneumococcal vaccine 23: a randomized clinical trialAllison R. Thompson; Nicola P. Klein; H. Jackson Downey; Scott Patterson; Vani Sundaraiyer; Wendy Watson; Keri Clarke; Kathrin U. Jansen; Shite Sebastian; William C. Gruber; Daniel A. Scott; Beate Schmoele-Thoma2019
Pneumococcal Conjugate Vaccine Safety in Elderly AdultsHung Fu Tseng; Lina S. Sy; Lei Qian; In-Lu A. Liu; Cheryl Mercado; Bruno Lewin; Sara Y. Tartof; Jennifer Nelson; Lisa A. Jackson; Matthew F. Daley; Eric Weintraub; Nicola P. Klein; Edward Belongia; Elizabeth G. Liles; Steven J. Jacobsen2018
Immunogenicity and safety of the 13-valent Pneumococcal Conjugate vaccine in 23-valent pneumococcal polysaccharide vaccine-naive and pre-immunized patients under treatment with chronic haemodialysis: a longitudinal quasi-experimental phase IV studyS. J. Vandecasteele; D. De Bacquer; R. Caluwe; S. Ombelet; B. Van Vlem2018
Evaluating clinical effectiveness of 13-valent pneumococcal conjugate vaccination against pneumonia among middle-aged and older adults in Catalonia: results from the EPIVAC cohort studyVila-Corcoles, Angel; Ochoa-Gondar, Olga; e Diego, Cinta; Satue, Eva; Aragn, Mara; Vila-Rovira, Angel; Gomez-Bertomeu, Frederic; Magarolas, Ramon; Figuerola-Massana, Enric; Raga, Xavier; Perez, Mar O.; Ballester, Frederic2018
Pneumococcal pneumonia and the risk of stroke: a population-based follow-up studyChen, L. F.; Chen, H. P.; Huang, Y. S.; Huang, K. Y.; Chou, P.; Lee, C. C.2012
Pneumococcal polysaccharide vaccination in adults undergoing immunosuppressive treatment for inflammatory diseases--a longitudinal studyLara Fischer; Patricia Francis Gerstel; Antoine Poncet; Claire-Anne Siegrist; Emmanuel Laffitte; Cem Gabay; Joerg Dieter Seebach; Camillo Ribi2015
Prevention of acute myocardial infarction and stroke among elderly persons by dual pneumococcal and influenza vaccination: a prospective cohort studyI. F. N. Hung; A. Y. M. Leung; D. W. S. Chu; D. Leung; T. Cheung; C.-K. Chan; C. L. K. Lam; S.-H. Liu; C.-M. Chu; P.-L. Ho; S. Chan; T.-H. Lam; R. Liang; K.-Y. Yuen2010
Impact of 23-valent pneumococcal polysaccharide vaccination on the frequency of pneumonia-related hospitalization and survival in elderly patients with prostate cancer: A seven-year nationwide matched cohort studyLi, Chung-Yi; Chen, Liang-Cheng; Lin, Hon-Yi; Lee, Moon-Sing; Hung, Shih-Kai; Lai, Chun-Liang; Huang, Li-Wen; Yu, Ben-Hui; Hsu, Feng-Chun; Chiou, Wen-Yen2020
Participant-Centered Online Active Surveillance for Adverse Events Following Vaccination in a Large Clinical Trial: Feasibility and Usability StudyS. A. Munnoch; P. Cashman; R. Peel; J. Attia; A. Hure; D. N. Durrheim2019
Evaluating the clinical effectiveness of pneumococcal vaccination in preventing myocardial infarction: The CAPAMIS study, three-year follow-upO. Ochoa-Gondar; A. Vila-Corcoles; T. Rodriguez-Blanco; C. de Diego-Cabanes; I. Hospital-Guardiola; M. Jariod-Pamies; Epivac Research Group2014
Immunogenicity and safety of an inactivated quadrivalent influenza vaccine co-administered with a 23-valent pneumococcal polysaccharide vaccine versus separate administration, in adults >=50years of age: Results from a phase III, randomized, non-inferiority trialOpokua Ofori-Anyinam; Geert Leroux-Roels; Mamadou Drame; Annelies Aerssens; Cathy Maes; Arshad Amanullah; Anne Schuind; Ping Li; Varsha K. Jain; Bruce L. Innis2017
Safety and Efficacy of Simultaneous Inoculations of Pneumococcal and Influenza Vaccines in Patients with Coronary Artery DiseaseShimada, Kazunori; Morinaga, Hiroaki; Kiyanagi, Takashi; Miyazaki, Tetsuro; Nishitani-Yokoyama, Miho; Okai, Iwao; Tamura, Hiroshi; Konishi, Hakuoh; Kurata, Takeshi; Miyauchi, Katsumi; Daida, Hiroyuki2020
Influenza and pneumococcal vaccination and risk of stroke or transient ischaemic attack-matched case control studySiriwardena, A. N.; Asghar, Z.; Coupland, C. C.2014
Immunogenicity and safety of concomitant MF59-adjuvanted influenza vaccine and 23-valent pneumococcal polysaccharide vaccine administration in older adultsJ. Y. Song; H. J. Cheong; T. F. Tsai; H. A. Chang; M. J. Choi; J. H. Jeon; S. H. Kang; E. J. Jeong; J. Y. Noh; W. J. Kim2015b
Associations between Pneumococcal Vaccination and Adverse Outcomes in Patients with Suspected Acute Coronary SyndromeZahid, M.; Singla, I.; Good, C.B.; l., et2012
Randomized Controlled Trial of the Safety and Immunogenicity of Revaccination With Tetanus-Diphtheria-Acellular Pertussis Vaccine (Tdap) in Adults 10 Years After a Previous DoseScott A. Halperin; Catherine Donovan; Gary S. Marshall; Vitali Pool; Michael D. Decker; David R. Johnson; David P. Greenberg; Investigators Tdap Booster2019
Safety and immunogenicity of an AS01-adjuvanted varicella-zoster virus subunit candidate vaccine against herpes zoster in adults >=50 years of ageRoman Chlibek; Jose M. Bayas; Harry Collins; Maria Luisa Rodriguez de la Pinta; Edouard Ledent; Johann F. Mols; Thomas C. Heineman2013
Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or OlderAnthony L. Cunningham; Himal Lal; Martina Kovac; Roman Chlibek; Shinn-Jang Hwang; Javier Diez-Domingo; Olivier Godeaux; Myron J. Levin; Janet E. McElhaney; Joan Puig-Barbera; Carline Vanden Abeele; Timo Vesikari; Daisuke Watanabe; Toufik Zahaf; Anitta Ahonen; Eugene Athan; Jose F. Barba-Gomez; Laura Campora; Ferdinandus de Looze; H. Jackson Downey; Wayne Ghesquiere; Iris Gorfinkel; Tiina Korhonen; Edward Leung; Shelly A. McNeil; Lidia Oostvogels; Lars Rombo; Jan Smetana; Lily Weckx; Wilfred Yeo; Thomas C. Heineman; Z. O. E. Study Group2016
Efficacy of an adjuvanted herpes zoster subunit vaccine in older adultsHimal Lal; Anthony L. Cunningham; Olivier Godeaux; Roman Chlibek; Javier Diez-Domingo; Shinn-Jang Hwang; Myron J. Levin; Janet E. McElhaney; Airi Poder; Joan Puig-Barbera; Timo Vesikari; Daisuke Watanabe; Lily Weckx; Toufik Zahaf; Thomas C. Heineman; Z. O. E. Study Group2015
Immunogenicity and safety of the adjuvanted recombinant zoster vaccine co-administered with the 23-valent pneumococcal polysaccharide vaccine in adults 50years of age: a randomized trialC. Marchal; H. Lal; A. Poder; M. Ferguson; I. Enweonye; T. C. Heineman; C. Herv; P. Rheault; J. Talli; D. Wauters; et al.2018
Immunogenicity and Safety of an Adjuvanted Herpes Zoster Subunit Vaccine Coadministered With Seasonal Influenza Vaccine in Adults Aged 50 Years or OlderTino F. Schwarz; Naresh Aggarwal; Beate Moeckesch; Isabelle Schenkenberger; Carine Claeys; Martine Douha; Olivier Godeaux; Katrijn Grupping; Thomas C. Heineman; Marta Lopez Fauqued; Lidia Oostvogels; Peter Van den Steen; Himal Lal2017
The adjuvanted recombinant zoster vaccine co-administered with a tetanus, diphtheria and pertussis vaccine in adults aged >=50 years: A randomized trialStrezova, Ana; Lal, Himal; Enweonye, Igwebuike; Campora, Laura; Beukelaers, Pierre; Segall, Nathan; Heineman, Thomas C.; Schuind, Anne E.; Oostvogels, Lidia2019
Randomized Comparison of Immunogenicity and Safety of Quadrivalent Recombinant Versus Inactivated Influenza Vaccine in Healthy Adults 18-49 Years of AgeLisa M. Dunkle; Ruvim Izikson; Peter A. Patriarca; Karen L. Goldenthal; Derek Muse; Manon M. J. Cox2017
Additive benefits of pneumococcal and influenza vaccines among elderly persons aged 75 years or older in Taiwan - A representative population-based comparative studyY. C. Chang; Y. J. Chou; J. Y. Liu; T. F. Yeh; N. Huang2012
Concomitant use of VAQTA with PedvaxHIB and Infanrix in 12 to 17 month old childrenM. Petrecz; K. P. Ramsey; J. E. Stek; J. C. Martin; S. O. Klopfer; B. Kuter; F. P. Schdel; A. W. Lee2016
Febrile Seizure Risk After Vaccination in Children 6 to 23 MonthsJonathan Duffy; Eric Weintraub; Simon J. Hambidge; Lisa A. Jackson; Elyse O. Kharbanda; Nicola P. Klein; Grace M. Lee; S. Michael Marcy; Cynthia C. Nakasato; Allison Naleway; Saad B. Omer; Claudia Vellozzi; Frank DeStefano2016
Methods for addressing "innocent bystanders" when evaluating safety of concomitant vaccinesWang, Shirley V.; Abdurrob, Abdurrahman; Spoendlin, Julia; Lewis, Edwin; Newcomer, Sophia R.; Fireman, Bruce; Daley, Matthew F.; Glanz, Jason M.; Duffy, Jonathan; Weintraub, Eric S.; Kulldorff, Martin
Adverse Events After Routine Immunization of Extremely Low-Birth-Weight InfantsDeMeo, S. D.; Raman, S. R.; Hornik, C. P.; Wilson, C. C.; Clark, R.; Smith, P. B.2015
Safety of diphtheria, tetanus, acellular pertussis and inactivated poliovirus (DTaP-IPV) vaccineMatthew F. Daley; W. Katherine Yih; Jason M. Glanz; Simon J. Hambidge; Komal J. Narwaney; Ruihua Yin; Lingling Li; Jennifer C. Nelson; James D. Nordin; Nicola P. Klein; Steven J. Jacobsen; Eric Weintraub2014
Safety of DTaP-IPV/Hib vaccine administered routinely to infants and toddlersJohn Hansen; Julius Timbol; Ned Lewis; Vitali Pool; Michael D. Decker; David P. Greenberg; Nicola P. Klein2016
Adapting group sequential methods to observational postlicensure vaccine safety surveillance: results of a pentavalent combination DTaP-IPV-Hib vaccine safety studyJ. C. Nelson; O. Yu; C. P. Dominguez-Islas; A. J. Cook; D. Peterson; S. K. Greene; W. K. Yih; M. F. Daley; S. J. Jacobsen; N. P. Klein; E. S. Weintraub; K. R. Broder; L. A. Jackson2013
Lot-to-lot Consistency, Safety, Tolerability and Immunogenicity of an Investigational Hexavalent Vaccine in US InfantsStanley L. Block; Nicola P. Klein; Kwabena Sarpong; Stephen Russell; John Fling; Maria Petrecz; Sheryl Flores; Jin Xu; Guanghan Liu; Jon E. Stek; Ginamarie Foglia; Andrew W. Lee2017
Immunogenicity, Safety, and Tolerability of a Hexavalent Vaccine in InfantsGary S. Marshall; Gregory L. Adams; Michael L. Leonardi; Maria Petrecz; Sheryl A. Flores; Angela L. Ngai; Jin Xu; Guanghan Liu; Jon E. Stek; Ginamarie Foglia; Andrew W. Lee2015
Safety and immunogenicity of a hexavalent vaccine administered at 2, 4 and 6 months of age with or without a heptavalent pneumococcal conjugate vaccine: a randomized, open-label studyB. Tapiero; S. A. Halperin; M. Dionne; W. Meekison; F. Diaz-Mitoma; P. Zickler; E. Rubin; J. Embree; P. Bhuyan; A. W. Lee; M. Li; A. Tomovici2013
Temporal Association of Certain Neuropsychiatric Disorders Following Vaccination of Children and Adolescents: A Pilot Case-Control StudyLeslie, D. L.; Kobre, R. A.; Richmand, B. J.; Aktan Guloksuz, S.; Leckman, J. F.2017
Immunogenicity and safety of a mixed vaccination schedule with one dose of nonavalent and one dose of bivalent HPV vaccine versus two doses of nonavalent vaccine - A randomized clinical trialVladimir Gilca; Chantal Sauvageau; Gitika Panicker; Gaston De Serres; Manale Ouakki; Elizabeth R. Unger2018
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Post licensure surveillance of influenza vaccines in the Vaccine Safety Datalink in the 2013-2014 and 2014-2015 seasonsRongxia Li; Brock Stewart; Michael M. McNeil; Jonathan Duffy; Jennifer Nelson; Alison Tse Kawai; Roger Baxter; Edward A. Belongia; Eric Weintraub2016
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Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine in US Children 6-35 Months of Age During 2013-2014: Results From A Phase II Randomized TrialLong Wang; Vijayalakshmi Chandrasekaran; Joseph B. Domachowske; Ping Li; Bruce L. Innis; Varsha K. Jain2016
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Evaluation of the safety of live attenuated influenza vaccine (LAIV) in children and adolescents with asthma and high-risk conditions: a population-based prospective cohort study conducted in England with the Clinical Practice Research DatalinkHerve Caspard; Amy Steffey; Raburn M. Mallory; Christopher S. Ambrose2018
The safety and efficacy of quadrivalent live attenuated influenza vaccine in Japanese children aged 2-18 years: Results of two phase 3 studiesRaburn M. Mallory; Jing Yu; Sachiko Kameo; Michio Tanaka; Ki Rito; Yohji Itoh; Filip Dubovsky2018b
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Safety of a quadrivalent meningococcal serogroups A, C, W and Y conjugate vaccine (MenACWY-CRM) administered with routine infant vaccinations: results of an open-label, randomized, phase 3b controlled study in healthy infantsArturo Abdelnour; Peter E. Silas; Marta Raquel Valdes Lamas; Carlos Fernando Grazioso Aragon; Nan-Chang Chiu; Cheng-Hsun Chiu; Teobaldo Herrera Acuna; Tirza De Leon Castrejon; Allen Izu; Tatjana Odrljin; Igor Smolenov; Matthew Hohenboken; Peter M. Dull2014
Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine in Healthy Meningococcal-Nave Children 2-9 Years of Age: A Phase III, Randomized StudyBaccarini, C. I.; Simon, M. W.; Brandon, D.; Christensen, S.; Jordanov, E.; Dhingra, M. S.2020
Immunogenicity and tolerability of a quadrivalent meningococcal glycoconjugate vaccine in children 2-10 years of ageS. Black; N. P. Klein; J. Shah; L. Bedell; A. Karsten; P. M. Dull2010
A Phase II, randomized, immunogenicity and safety study of a quadrivalent meningococcal conjugate vaccine, MenACYW-TT, in healthy adolescents in the United StatesL. J. Chang; J. Hedrick; S. Christensen; J. Pan; E. Jordanov; M. S. Dhingra2020
A Phase II, randomized, immunogenicity and safety study of a quadrivalent meningococcal conjugate vaccine, MenACYW-TT, in healthy adolescents in the United StatesChang, L. J.; Hedrick, J.; Christensen, S.; Pan, J.; Jordanov, E.; Dhingra, M. S.2020b
Immunogenicity and safety of combined tetanus, reduced diphtheria, acellular pertussis vaccine when co-administered with quadrivalent meningococcal conjugate and human papillomavirus vaccines in healthy adolescentsGasparini, R; Johnston, W; Conversano, M; Garscadden, A; Alexanderian, D; Giglioli, N; Percell, S; Han, L; Smolenov, I2014
Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of AgeEuctr Outside EU/EEA,; Euctr Outside EU/EEA,2014
Immunogenicity and safety of a quadrivalent meningococcal polysaccharide CRM conjugate vaccine in infants and toddlersMiguel Tregnaghi; Pio Lopez; Daniel Stamboulian; Gabriela Grana; Tatjana Odrljin; Lisa Bedell; Peter M. Dull2014
Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine in healthy adolescents in Korea--A randomised trialHoan Jong Lee; Young June Choe; Young-Jin Hong; Kyung-Hyo Kim; Su Eun Park; Yun-Kyung Kim; Chi-Eun Oh; Hyunju Lee; Hyoyoung Song; Hans Bock; Daniela Casula; Chiranjiwi Bhusal; Ashwani Kumar Arora2016
Safety, immunogenicity, and tolerability of meningococcal serogroup B bivalent recombinant lipoprotein 2086 vaccine in healthy adolescents: A randomised, single-blind, placebo-controlled, phase 2 trialP. C. Richmond; H. S. Marshall; M. D. Nissen; Q. Jiang; K. U. Jansen; M. Garces-Sanchez; F. Martinon-Torres; J. Beeslaar; L. Szenborn; J. Wysocki; J. Eiden; S. L. Harris; T. R. Jones; J. L. Perez2012
Immunogenicity and tolerability of a multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile: a phase 2b/3 randomised, observer-blind, placebo-controlled studyM. E. Santolaya; M. L. O'Ryan; M. T. Valenzuela; V. Prado; R. Vergara; A. Munoz; D. Toneatto; G. Grana; H. Wang; R. Clemens; P. M. Dull; V. P. M. B. A. V. S. group2012
Immunogenicity, Tolerability and Safety in Adolescents of Bivalent rLP2086, a Meningococcal Serogroup B Vaccine, Coadministered with Quadrivalent Human Papilloma Virus VaccineShelly Senders; Prakash Bhuyan; Qin Jiang; Judith Absalon; Joseph J. Eiden; Thomas R. Jones; Laura J. York; Kathrin U. Jansen; Robert E. O'Neill; Shannon L. Harris; John Ginis; John L. Perez2016
Immunogenicity, Safety, and Tolerability of Bivalent rLP2086 Meningococcal Group B Vaccine Administered Concomitantly With Diphtheria, Tetanus, and Acellular Pertussis and Inactivated Poliomyelitis Vaccines to Healthy AdolescentsTimo Vesikari; Jacek Wysocki; Johannes Beeslaar; Joseph Eiden; Qin Jiang; Kathrin U. Jansen; Thomas R. Jones; Shannon L. Harris; Robert E. O'Neill; Laura J. York; John L. Perez2016
A longitudinal cohort study of childhood MMR vaccination and seizure disorder among American childrenGeier, D. A.; Geier, M. R.2020
Measles, Mumps, Rubella Vaccination and Autism: A Nationwide Cohort StudyAnders Hviid; Jorgen Vinslov Hansen; Morten Frisch; Mads Melbye2019
Autism occurrence by MMR vaccine status among US children with older siblings with and without autismAnjali Jain; Jaclyn Marshall; Ami Buikema; Tim Bancroft; Jonathan P. Kelly; Craig J. Newschaffer2015
Asthma and allergy in children with and without prior measles, mumps, and rubella vaccinationClara Amalie Gade Timmermann; Christa Elyse Osuna; Ulrike Steuerwald; Pal Weihe; Lars K. Poulsen; Philippe Grandjean2015
Early exposure to the combined measles-mumps-rubella vaccine and thimerosal-containing vaccines and risk of autism spectrum disorderUno, Y.; Uchiyama, T.; Kurosawa, M.; Aleksic, B.; Ozaki, N.2015
Similar relative risks of seizures following measles containing vaccination in children born preterm compared to full-term without previous seizures or seizure-related disordersMcClure, D. L.; Jacobsen, S. J.; Klein, N. P.; Naleway, A. L.; Kharbanda, E. O.; Glanz, J. M.; Jackson, L. A.; Weintraub, E. S.; McLean, H. Q.2019
Immunogenicity and safety of a combined measles, mumps, rubella and varicella live vaccine (ProQuad ) administered concomitantly with a booster dose of a hexavalent vaccine in 12-23-month-old infantsKlaus A. Deichmann; Giuseppe Ferrera; Clement Tran; Stephane Thomas; Cecile Eymin; Martine Baudin2015
Measles-mumps-rubella-varicella combination vaccine and the risk of febrile seizuresN. P. Klein; B. Fireman; W. K. Yih; E. Lewis; M. Kulldorff; P. Ray; R. Baxter; S. Hambidge; J. Nordin; A. Naleway; E. A. Belongia; T. Lieu; J. Baggs; E. Weintraub; D. Vaccine Safety2010
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Kawasaki disease and 13-valent pneumococcal conjugate vaccination among young children: A self-controlled risk interval and cohort study with null resultsMeghan A. Baker; Bethany Baer; Martin Kulldorff; Lauren Zichittella; Rebecca Reindel; Sandra DeLuccia; Hana Lipowicz; Katherine Freitas; Robert Jin; W. Katherine Yih2019
The risk of febrile seizures following influenza and 13-valent pneumococcal conjugate vaccinesBaker, M. A.; Jankosky, C.; Yih, W. K.; Gruber, S.; Li, L.; Cocoros, N. M.; Lipowicz, H.; Coronel-Moreno, C.; DeLuccia, S.; Lin, N. D.; McMahill-Walraven, C. N.; Menschik, D.; Selvan, M. S.; Selvam, N.; Chen Tilney, R.; Zichittella, L.; Lee, G. M.; Kawai, A. T.2020
Immunogenicity and safety of one or two doses of the quadrivalent meningococcal vaccine MenACWY-TT given alone or with the 13-valent pneumococcal conjugate vaccine in toddlers: A phase III, open-label, randomised studyClare L. Cutland; Terry Nolan; Scott A. Halperin; Zafer Kurugol; Khatija Ahmed; Kirsten P. Perrett; Peter Richmond; Helen S. Marshall; Mehmet Ceyhan; Devayani Kolhe; Marjan Hezareh; Marie Van Der Wielen2018
Comparative immunogenicity and efficacy of 13-valent and 7-valent pneumococcal conjugate vaccines in reducing nasopharyngeal colonization: a randomized double-blind trialRon Dagan; Scott Patterson; Christine Juergens; David Greenberg; Noga Givon-Lavi; Nurith Porat; Alejandra Gurtman; William C. Gruber; Daniel A. Scott2013
Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine given to korean children receiving routine pediatric vaccinesD. S. Kim; S. H. Shin; H. J. Lee; Y. J. Hong; S. Y. Lee; K. M. Choi; C. E. Oh; K. H. Kim; C. Juergens; S. Patterson; P. C. Giardina; W. C. Gruber; E. A. Emini; D. A. Scott2013
Risk of fever after pediatric trivalent inactivated influenza vaccine and 13-valent pneumococcal conjugate vaccineMelissa S. Stockwell; Karen Broder; Philip LaRussa; Paige Lewis; Nadira Fernandez; Devindra Sharma; Angela Barrett; Jose Sosa; Claudia Vellozzi2014
Immunogenicity and Safety of a 13-Valent Pneumococcal Conjugate Vaccine Given With DTaP Vaccine in Healthy Infants in JapanTakehiro Togashi; Kenji Okada; Masako Yamaji; Allison Thompson; Alejandra Gurtman; Mark Cutler; Masakazu Aizawa; William C. Gruber; Daniel A. Scott2015
Postlicensure surveillance for pre-specified adverse events following the 13-valent pneumococcal conjugate vaccine in childrenH. F. Tseng; L. S. Sy; I. L. A. Liu; L. Qian; S. M. Marcy; E. Weintraub; K. Yih; R. Baxter; J. M. Glanz; J. Donahue; A. Naleway; J. Nordin; S. J. Jacobsen2013
Kawasaki Disease following administration of 13-valent pneumococcal conjugate vaccine in young childrenYung, Chee Fu; Ma, Xiangmei; Cheung, Yin Bun; Oh, Bee Khiam; Soh, Sally; Thoon, Koh Cheng2019
Clinical Tolerance of In-Neonatal Intensive Care Unit Administration of Rotavirus VaccineCourtney Briggs-Steinberg; David Aboudi; Gabrielle Hodson; Shetal Shah2019
Does Rotavirus Vaccination Affect Longer-Term Intussusception Risk in US Infants?Burke, R. M.; Tate, J. E.; Dahl, R. M.; Aliabadi, N.; Parashar, U. D.2020
Intussusception risk and disease prevention associated with rotavirus vaccines in Australia's National Immunization ProgramJohn B. Carlin; Kristine K. Macartney; Katherine J. Lee; Helen E. Quinn; Jim Buttery; Ruth Lopert; Julie Bines; Peter B. McIntyre2013
Trends in Hospitalizations for Intussusception in California in Relationship to the Introduction of New Rotavirus Vaccines, 1985-2010Despina G. Contopoulos-Ioannidis; Meira S. Halpern; Yvonne Maldonado2015
Evaluation of safety and immunogenicity of a live attenuated tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus vaccine (BRV-TV) in healthy Indian adults and infantsM. S. Dhingra; R. Kundu; M. Gupta; S. Kanungo; N. Ganguly; M. P. Singh; M. K. Bhattacharya; R. Ghosh; R. Kumar; D. Sur; S. M. Chadha; T. Saluja2014
Intussusception risk after RotaTeq vaccination: evaluation from worldwide spontaneous reporting data using a self-controlled case series approachEscolano, S.; Hill, C.; Tubert-Bitter, P.2015
Hospital-based surveillance of intussusception among infantsEder Gatti Fernandes; Eyal Leshem; Manish Patel; Brendan Flannery; Alessandra Cristina Guedes Pellini; Maria Amelia Veras; Helena Keico Sato2016
A case-control study of risk factors for intussusception among infants in eastern France after the introduction of the rotavirus vaccineA. Fotso Kamdem; C. Vidal; L. Pazart; F. Leroux; A. Pugin; C. Savet; G. Sainte-Claire Deville; D. Guillemot; J. Massol2019
Association between Rotavirus Vaccination and Type 1 Diabetes in ChildrenJ. M. Glanz; C. L. Clarke; S. Xu; M. F. Daley; J. A. Shoup; E. B. Schroeder; B. J. Lewin; D. L. McClure; E. Kharbanda; N. P. Klein; F. Destefano2020
Evaluation of intussusception after oral monovalent rotavirus vaccination in South AfricaMichelle J. Groome; Jacqueline E. Tate; Marion Arnold; Milind Chitnis; Sharon Cox; Corne de Vos; Mari Kirsten; Susanna M. le Grange; Jerome Loveland; Sello Machaea; Ashwini Maharaj; Nick Andrews; Shabir A. Madhi; Umesh D. Parashar2019
Survey of rotavirus-associated severe complications in Aichi PrefectureF. Hattori; Y. Kawamura; J. I. Kawada; S. Kojima; J. Natsume; K. Ito; S. Saito; Y. Kitagawa; A. Okumura; T. Yoshikawa2018
Assessing the risk of intussusception and rotavirus vaccine safety in CanadaSteven Hawken; Robin Ducharme; Laura C. Rosella; Eric I. Benchimol; Joanne M. Langley; Kumanan Wilson; Natasha S. Crowcroft; Scott A. Halperin; Shalina Desai; Monika Naus; Carolyn J. Sanford; Salah M. Mahmud; Shelley L. Deeks2017
Safety study of live, oral human rotavirus vaccine: A cohort study in United States health insurance plansVeena Hoffman; Remon Abu-Elyazeed; Cheryl Enger; Daina B. Esposito; Michael C. Doherty; Scott C. Quinlan; Kathleen Skerry; Crystal N. Holick; Peter Basile; Leonard R. Friedland; Nicolas Praet; Stephanie Wery; Corinne Willame; David D. Dore; Dominique Rosillon2018
Intussusception and Kawasaki disease after rotavirus vaccination in Taiwanese infantsHuang, Wan-Ting; Juan, Yi-Chen; Liu, Chia-Hung; Yang, Yen-Yun; Chan, K. Arnold2020
Efficacy and safety of pentavalent rotavirus vaccine in Japan: a randomized, double-blind, placebo-controlled, multicenter trialSatoshi Iwata; Shuji Nakata; Susumu Ukae; Yoshitugu Koizumi; Yasuyuki Morita; Haruo Kuroki; Yoshiyuki Tanaka; Toshiyuki Shizuya; Florian Schodel; Michelle L. Brown; Jody Lawrence2013
Rotavirus vaccination and short-term risk of adverse events in US infantsJ. Bradley Layton; Anne M. Butler; Catherine A. Panozzo; M. Alan Brookhart2018
Impact of rotavirus vaccination on intussusception hospital admissions in EnglandMcGeoch, L. J.; Finn, A.; Marlow, R. D.2020
Efficacy and safety of a pentavalent live human-bovine reassortant rotavirus vaccine (RV5) in healthy Chinese infants: A randomized, double-blind, placebo-controlled trialZhaojun Mo; Yi Mo; Mingqiang Li; Junhui Tao; Xu Yang; Jilian Kong; Dingkai Wei; Botao Fu; Xueyan Liao; Jianli Chu; Yuanzheng Qiu; Darcy A. Hille; Micki Nelson; Susan S. Kaplan2017
Retrospective multicenter matched case-control study on the risk factors for intussusception in infants less than 1 year of age with a special focus on rotavirus vaccines - the German Intussusception StudyDoris Oberle; Marcus Hoffelner; Jutta Pavel; Dirk Mentzer; Immanuel Barth; Ursula Drechsel-Bauerle; Brigitte Keller-Stanislawski2020
Lower Incidence Rate of Type 1 Diabetes after Receipt of the Rotavirus Vaccine in the United States, 20012017M. A. M. Rogers; T. Basu; C. Kim2019
Impact of rotavirus vaccination on childhood hospitalizations for seizures: Heterologous or unforeseen direct vaccine effects?A. Salas; J. Pardo-Seco; M. Cebey-Lopez; J. M. Martinon-Martinez; J. Gomez-Rial; M. J. Curras-Tuala; S. Pischedda; R. Barral-Arca; A. Justicia-Grande; I. Rivero-Calle; J. Vilar; F. Martinon-Torres2019
Intussusception Rates Before and After the Introduction of Rotavirus VaccineJacqueline E. Tate; Catherine Yen; Claudia A. Steiner; Margaret M. Cortese; Umesh D. Parashar2016
Evaluation of Intussusception after Monovalent Rotavirus Vaccination in AfricaTate, J. E.; Mwenda, J. M.; Armah, G.; Jani, B.; Omore, R.; Ademe, A.; Mujuru, H.; Mpabalwani, E.; Ngwira, B.; Cortese, M. M.; Mihigo, R.; Glover-Addy, H.; Mbaga, M.; Osawa, F.; Tadesse, A.; Mbuwayesango, B.; Simwaka, J.; Cunliffe, N.; Lopman, B. A.; Weldegebriel, G.; Ansong, D.; Msuya, D.; Ogwel, B.; Karengera, T.; Manangazira, P.; Bvulani, B.; Yen, C.; Zawaira, F. R.; Narh, C. T.; Mboma, L.; Saula, P.; Teshager, F.; Getachew, H.; Moeti, R. M.; Eweronu-Laryea, C.; Parashar, U. D.2018
Impact of rotavirus vaccination in Germany: rotavirus surveillance, hospitalization, side effects and comparison of vaccinesUlrike Uhlig; Karel Kostev; Volker Schuster; Sibylle Koletzko; Holm H. Uhlig
Rotavirus Vaccination and the Risk of Celiac Disease or Type 1 Diabetes in Finnish Children at Early LifeOuti Vaarala; Jukka Jokinen; Mika Lahdenkari; Tuija Leino2017
Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled studyT. Vesikari; A. Karvonen; R. Prymula; V. Schuster; J. Tejedor; R. Cohen; F. Meurice; H. Han; S. Damaso; A. Bouckenooghe2007
Intussusception risk after rotavirus vaccination in U.S. infantsW. Katherine Yih; Tracy A. Lieu; Martin Kulldorff; David Martin; Cheryl N. McMahill-Walraven; Richard Platt; Nandini Selvam; Mano Selvan; Grace M. Lee; Michael Nguyen2014
Intussusception and Monovalent Rotavirus Vaccination in Singapore: Self-Controlled Case Series and Risk-Benefit StudyYung, C. F.; Chan, S. P.; Soh, S.; Tan, A.; Thoon, K. C.2015
Human rotavirus vaccine (RIX4414) efficacy in the first two years of life: a randomized, placebo-controlled trial in ChinaRong-cheng Li; Teng Huang; Yanping Li; Dong Luo; Junhui Tao; Botao Fu; Guoai Si; Yi Nong; Zhaojun Mo; XueYan Liao; Ivy Luan; Haiwen Tang; Niraj Rathi; Naveen Karkada; Htay Htay Han2014
Sudden-Onset Sensorineural Hearing Loss after Immunization: A Case-Centered AnalysisBaxter, R.; Lewis, N.; Bohrer, P.; Harrington, T.; Aukes, L.; Klein, N. P.2016
Acute Demyelinating Events Following Vaccines: A Case-Centered AnalysisBaxter, R.; Lewis, E.; Goddard, K.; Fireman, B.; Bakshi, N.; DeStefano, F.; Gee, J.; Tseng, H. F.; Naleway, A. L.; Klein, N. P.2016
Near real-time surveillance to assess the safety of the 9-valent human papillomavirus vaccineJ. G. Donahue; B. A. Kieke; E. M. Lewis; E. S. Weintraub; K. E. Hanson; D. L. McClure; E. R. Vickers; J. Gee; M. F. Daley; F. DeStefano; R. C. Hechter; L. A. Jackson; N. P. Klein; A. L. Naleway; J. C. Nelson; E. A. Belongia2019
Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccineSuzanne M. Garland; Tak-Hong Cheung; Shelly McNeill; Lone Kjeld Petersen; Josefina Romaguera; Jorge Vazquez-Narvaez; Oliver Bautista; Christine Shields; Scott Vuocolo; Alain Luxembourg2015
Final efficacy, immunogenicity, and safety analyses of a nine-valent human papillomavirus vaccine in women aged 16-26 years: a randomised, double-blind trialWarner K. Huh; Elmar A. Joura; Anna R. Giuliano; Ole-Erik Iversen; Rosires Pereira de Andrade; Kevin A. Ault; Deborah Bartholomew; Ramon M. Cestero; Edison N. Fedrizzi; Angelica L. Hirschberg; Marie-Helene Mayrand; Angela Maria Ruiz-Sternberg; Jack T. Stapleton; Dorothy J. Wiley; Alex Ferenczy; Robert Kurman; Brigitte M. Ronnett; Mark H. Stoler; Jack Cuzick; Suzanne M. Garland; Susanne K. Kjaer; Oliver M. Bautista; Richard Haupt; Erin Moeller; Michael Ritter; Christine C. Roberts; Christine Shields; Alain Luxembourg2017
A phase III clinical study to compare the immunogenicity and safety of the 9-valent and quadrivalent HPV vaccines in menPierre Van Damme; Chris J. L. M. Meijer; Dorothee Kieninger; Anne Schuyleman; Stephane Thomas; Alain Luxembourg; Martine Baudin2016
Safety of quadrivalent live attenuated influenza vaccine in subjects aged 2-49yearsRoger Baxter; Abigail Eaton; John Hansen; Laurie Aukes; Herve Caspard; Christopher S. Ambrose2017
Immunogenicity and safety of a booster dose of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adolescents and adults: a Phase III randomized studyAnez, G.; Hedrick, J.; Simon, M. W.; Christensen, S.; Jeanfreau, R.; Yau, E.; Pan, J.; Jordanov, E.; Dhingra, M. S.2020
Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccineJ. Hansen; L. Zhang; N. P. Klein; C. A. Robertson; M. D. Decker; D. P. Greenberg; E. Bassily; R. Baxter2017
Immunogenicity and safety of a novel quadrivalent meningococcal conjugate vaccine (MenACWY-CRM) in healthy Korean adolescents and adultsHoan Jong Lee; Moon-Hyun Chung; Woo Joo Kim; Young Jin Hong; Kyong Min Choi; Jina Lee; Chi Eun Oh; Jo Anne Welsch; Kyung-Hyo Kim; Ki Bae Hong; Alemnew F. Dagnew; Hans Bock; Peter M. Dull; Tatjana Odrljin2014
Safety of Quadrivalent Meningococcal Conjugate Vaccine in 11- to 21-Year-OldsHung-Fu Tseng; Lina S. Sy; Bradley K. Ackerson; Rulin C. Hechter; Sara Y. Tartof; Mendel Haag; Jeffrey M. Slezak; Yi Luo; Christine A. Fischetti; Harp S. Takhar; Yan Miao; Marianne Cunnington; Zendi Solano; Steven J. Jacobsen2017
Primary Ovarian Insufficiency and Adolescent VaccinationAllison L. Naleway; Kathleen F. Mittendorf; Stephanie A. Irving; Michelle L. Henninger; Bradley Crane; Ning Smith; Matthew F. Daley; Julianne Gee2018
A phase 3, randomized, active-controlled study to assess the safety and tolerability of meningococcal serogroup B vaccine bivalent rLP2086 in healthy adolescents and young adultsLars Ostergaard; Gregg H. Lucksinger; Judith Absalon; Johannes Beeslaar; Joseph Eiden; Kathrin U. Jansen; Laura J. York; Angela Quinn; Mette E. Graversen; John L. Perez2016
Immunogenicity and safety of the quadrivalent meningococcal vaccine MenACWY-TT co-administered with a combined diphtheria-tetanus-acellular pertussis vaccine versus their separate administration in adolescents and young adults: A phase III, randomized studyL. Rivera; T. F. Schwarz; K. H. Kim; Y. K. Kim; U. Behre; S. H. Cha; D. S. Jo; J. Lee; J. S. Lee; B. Cheuvart; A. Jastorff; M. Van der Wielen2018
Active SMS-based surveillance of adverse events following immunisation with influenza and pertussis-containing vaccines in Australian pregnant women using AusVaxSafetyGlover, C.; Crawford, N.; Leeb, A.; Wood, N.; Macartney, K.2020
Preventing pertussis in the early infant: Development and results of a prenatal vaccination programJ. Acosta; C. Benages; M. A. Daz; M. Xiberta; F. Muiz2016
The Association of Prenatal Tetanus, Diphtheria, and Acellular Pertussis (Tdap) Vaccination With Attention-Deficit/Hyperactivity DisorderBecerra-Culqui, T. A.; Getahun, D.; Chiu, V.; Sy, L. S.; Tseng, H. F.2020
Maternal and infant outcomes among women vaccinated against pertussis during pregnancyAbbey B. Berenson; Jacqueline M. Hirth; Mahbubur Rahman; Tabassum H. Laz; Richard E. Rupp; Kwabena O. Sarpong2016
Maternal Tdap vaccination and risk of infant morbidityMalini DeSilva; Gabriela Vazquez-Benitez; James D. Nordin; Heather S. Lipkind; Nicola P. Klein; T. Craig Cheetham; Allison L. Naleway; Simon J. Hambidge; Grace M. Lee; Michael L. Jackson; Natalie L. McCarthy; Elyse O. Kharbanda2017
Pertussis Immunisation in Pregnancy Safety (PIPS) Study: A retrospective cohort study of safety outcomes in pregnant women vaccinated with Tdap vaccineJennifer B. Griffin; Lennex Yu; Donna Watson; Nikki Turner; Tony Walls; Anna S. Howe; Yannan Jiang; Helen Petousis-Harris2018
Safety of tetanus, diphtheria, and acellular pertussis vaccination among pregnant active duty U.S. military womenC. Hall; L. M. Abramovitz; A. T. Bukowinski; A. A. Ricker; Z. G. Khodr; G. R. Gumbs; N. Y. Wells; A. M. S. Conlin2020
A Randomized Controlled Trial of the Safety and Immunogenicity of Tetanus, Diphtheria, and Acellular Pertussis Vaccine Immunization During Pregnancy and Subsequent Infant Immune ResponseScott A. Halperin; Joanne M. Langley; Lingyun Ye; Donna MacKinnon-Cameron; May Elsherif; Victoria M. Allen; Bruce Smith; Beth A. Halperin; Shelly A. McNeil; Otto G. Vanderkooi; Shannon Dwinnell; R. Douglas Wilson; Bruce Tapiero; Marc Boucher; Nicole Le Saux; Andree Gruslin; Wendy Vaudry; Sue Chandra; Simon Dobson; Deborah Money2018
Maternal Tdap vaccination: Coverage and acute safety outcomes in the vaccine safety datalink, 2007-2013Elyse Olshen Kharbanda; Gabriela Vazquez-Benitez; Heather S. Lipkind; Nicola P. Klein; T. Craig Cheetham; Allison L. Naleway; Grace M. Lee; Simon Hambidge; Michael L. Jackson; Saad B. Omer; Natalie McCarthy; James D. Nordin2016
Prenatal Tdap immunization and risk of maternal and newborn adverse eventsJ. Bradley Layton; Anne M. Butler; Dongmei Li; Kim A. Boggess; David J. Weber; Leah J. McGrath; Sylvia Becker-Dreps2017
Pregnancy outcomes after antepartum tetanus, diphtheria, and acellular pertussis vaccinationJamie L. Morgan; Sangameshwar R. Baggari; Donald D. McIntire; Jeanne S. Sheffield2015
Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trialFlor M. Munoz; Nanette H. Bond; Maurizio Maccato; Phillip Pinell; Hunter A. Hammill; Geeta K. Swamy; Emmanuel B. Walter; Lisa A. Jackson; Janet A. Englund; Morven S. Edwards; C. Mary Healy; Carey R. Petrie; Jennifer Ferreira; Johannes B. Goll; Carol J. Baker2014
Randomized clinical trial of the safety and immunogenicity of the Tdap vaccine in pregnant Mexican womenJ. Z. V. Perez; J. M. R. Aranda; M. de la O Cavazos; M. D. Z. Osuna; J. P. Davila; M. R. B. Elizondo; M. V. G. Meza; F. J. G. Elizondo; A. M. R. Gonzalez2017
Immunogenicity, transplacental transfer of pertussis antibodies and safety following pertussis immunization during pregnancy: Evidence from a randomized, placebo-controlled trialKirsten P. Perrett; Scott A. Halperin; Terry Nolan; Cristina Martinez Pancorbo; Bruce Tapiero; Federico Martinon-Torres; Zbynek Stranak; Miia Virta; Otto G. Vanderkooi; Pavel Kosina; Maria Begona Encinas Pardilla; Ignacio Cristobal Garcia; Gian Vincenzo Zuccotti; Lusine Kostanyan; Nadia Meyer; Maria Angeles Ceregido; Brigitte Cheuvart; Sherine O. Kuriyakose; Manuel Marcos Fernandez; Miguel Angel Rodriguez Zambrano; Adrian Martin Garcia; Juan Eloy Asenjo de la Fuente; Maria Dolores Camacho Marin; Maria de la Calle Fernandez-Miranda; Yolanda Romero Espinar; Paola Giovanna Marchisio; Paolo Manzoni; Narcisa Mesaros2019
A Retrospective Cohort Study of Safety Outcomes in New Zealand Infants Exposed to Tdap Vaccine in UteroH. Petousis-Harris; Y. N. Jiang; L. Yu; D. Watson; T. Walls; N. Turner; A. S. Howe; J. B. Griffin2019
Safety of reduced antigen content diphtheria-tetanus-acellular pertussis vaccine when administered during pregnancy as part of the maternal immunization program in Brazil: a single center, observational, retrospective, cohort studyMauro Sancovski; Narcisa Mesaros; Yang Feng; M. Angeles Ceregido; Dominique Luyts; Eliana De Barros2019
Tetanus, diphtheria, acellular pertussis vaccine during pregnancy: pregnancy and infant health outcomesJulie H. Shakib; Kent Korgenski; Xiaoming Sheng; Michael W. Varner; Andrew T. Pavia; Carrie L. Byington2013
Prenatal Tetanus, Diphtheria, Acellular Pertussis Vaccination and Autism Spectrum DisorderTracy A. Becerra-Culqui; Darios Getahun; Vicki Chiu; Lina S. Sy; Hung Fu Tseng2018
Immunogenicity, safety and inter-lot consistency of a meningococcal conjugate vaccine (MenACYW-TT) in adolescents and adults: A Phase III randomized studyDhingra, M. S. Peterson; J. Hedrick, J. Pan; J. Neveu, D. Jordanov2020
Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine (MenACWY-D) in infants and childrenJ. Hansen; L. Zhang; A. Eaton; R. Baxter; C. A. Robertson; M. D. Decker; D. P. Greenberg; E. Bassily; N. P. Klein2018
The impact of hepatitis B vaccination status on the risk of diabetes, implicating diabetes risk reduction by successful vaccinationJ. Huang; H. Y. Ou; J. Lin; R. Karnchanasorn; W. Feng; R. Samoa; L. M. Chuang; K. C. Chiu2015
The risk of intussusception following monovalent rotavirus vaccination in England: A self-controlled case-series evaluationJ. Stowe; N. Andrews; S. Ladhani; E. Miller2016

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