Monitoring the safety of quadrivalent human papillomavirus vaccine: Findings from the Vaccine Safety Datalink

Gee, Julianne; Naleway, Allison L.; Shui, Irene M.; Baggs, James; Yin, Ruihua; Li, Rong; Kulldorff, Martin; Lewis, Edwin; Fireman, Bruce; Daley, Matthew F.; Klein, Nicola P.; Weintraub, Eric

doi:10.1016/j.vaccine.2011.08.106

Cited by 203 publications

(163 citation statements)

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“…The risk intervals were chosen based on previous studies, 8,20,23,24 CDC input, and expert opinion. Similar to previous vaccine safety studies that focused resources on statistically significant outcomes, 16,[25][26][27][28] …”

Section: Study Populationmentioning

confidence: 90%

Safety of Measles-Containing Vaccines in 1-Year-Old Children

et al. 2015

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BACKGROUND AND OBJECTIVES: All measles-containing vaccines are associated with several types of adverse events, including seizure, fever, and immune thrombocytopenia purpura (ITP). Because the measles-mumps-rubellavaricella (MMRV) vaccine compared with the separate measles-mumps-rubella (MMR) and varicella (MMR + V) vaccine increases a toddler's risk for febrile seizures, we investigated whether MMRV is riskier than MMR + V and whether either vaccine elevates the risk for additional safety outcomes.

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Section: Study Populationmentioning

confidence: 90%

Safety of Measles-Containing Vaccines in 1-Year-Old Children

et al. 2015

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“…Data have shown that prophylactic HPV vaccination is generally safe and well tolerated. [32][33][34][35][36][37][38] The median age of sexual debut is in the late teens (15-19 years) in most countries. 39 Virginal adolescents (#15 years old) were not included in HPV vaccine efficacy evaluations because of low HPV exposure and ethical constraints.…”

Section: What This Study Addsmentioning

confidence: 99%

Immunogenicity and Safety of a 9-Valent HPV Vaccine

et al. 2015

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OBJECTIVES: Prophylactic vaccination of youngwomen aged 16 to 26 years with the 9-valent (6/11/16/18/31/33/45/52/58) human papillomavirus (HPV) virus-like particle (9vHPV) vaccine prevents infection and disease. We conducted a noninferiority immunogenicity study to bridge the findings in young women to girls and boys aged 9 to 15 years.METHODS: Subjects (N = 3066) received a 3-dose regimen of 9vHPV vaccine administered at day 1, month 2, and month 6. Anti-HPV serologic assays were performed at day 1 and month 7. Noninferiority required that the lower bound of 2-sided 95% confidence intervals of geometric mean titer ratios (boys:young women or girls:young women) be .0.67 for each HPV type. Systemic and injection-site adverse experiences (AEs) and serious AEs were monitored.RESULTS: At 4 weeks after dose 3, .99% of girls, boys, and young women seroconverted for each vaccine HPV type. Increases in geometric mean titers to HPV types 6/11/16/18/ 31/33/45/52/58 were elicited in all vaccine groups. Responses in girls and boys were noninferior to those of young women. Persistence of anti-HPV responses was demonstrated through 2.5 years after dose 3. Administration of the 9vHPV vaccine was generally well tolerated. A lower proportion of girls (81.9%) and boys (72.8%) than young women (85.4%) reported injection-site AEs, most of which were mild to moderate in intensity.CONCLUSIONS: These data support bridging the efficacy findings with 9vHPV vaccine in young women 16 to 26 years of age to girls and boys 9 to 15 years of age and implementing genderneutral HPV vaccination programs in preadolescents and adolescents.WHAT'S KNOWN ON THIS SUBJECT: Prophylactic vaccination of young women 16 to 26 years of age with the 9-valent human papillomavirus (HPV)-like particle (9vHPV) vaccine prevents infection and disease with vaccine HPV types.WHAT THIS STUDY ADDS: These data support bridging the efficacy findings with 9vHPV vaccine in young women 16 to 26 years of age to girls and boys 9 to 15 years of age and implementation of gender-neutral HPV vaccination programs in preadolescents and adolescents.

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“…The study used generally accepted risk windows in vaccine safety studies on the basis of biological plausibility so that the results could be compared with other studies. 16 Fourth, for non-CRC reviewed events, medical records were further reviewed only when there was a statistically significant increased risk. acquisition of data; Dr Jacobsen contributed to the conception and design of the study and conduct of the study; and all authors approved the fi nal manuscript as submitted.…”

Section: Discussionmentioning

confidence: 99%