Safety profile of the 9-valent HPV vaccine: A combined analysis of 7 phase III clinical trials

Edson D. Moreira, Stan L. Block, Daron Ferris, Anna R. Giuliano, Ole Erik Iversen, Elmar A. Joura, Pope Kosalaraksa, Andrea Schilling, Pierre Van Damme, Jacob Bornstein, F. Xavier Bosch, Sophie Pils, Jack Cuzick, Suzanne M. Garland, Warner Huh, Susanne K. Kjaer, Hong Qi, Donna Hyatt, Jason Martin, Erin MoellerMichael Ritter, Martine Baudin, Alain Luxembourg

Research output: Contribution to journalArticle

40 Scopus citations

Abstract

OBJECTIVES: The overall safety profile of the 9-valent human papillomavirus (9vHPV) vaccine was evaluated across 7 Phase III studies, conducted in males and females (nonpregnant at entry), 9 to 26 years of age. METHODS: Vaccination was administered as a 3-dose regimen at day 1, and months 2 and 6. More than 15 000 subjects received ≥1 dose of 9vHPV vaccine. In 2 of the studies, >7000 control subjects received ≥1 dose of quadrivalent HPV (qHPV) vaccine. Serious and nonserious adverse events (AEs) and new medical conditions were recorded throughout the study. Subjects testing positive for pregnancy at day 1 were not vaccinated; those who became pregnant after day 1 were discontinued from further vaccination until resolution of the pregnancy. Pregnancies detected after study start (n = 2950) were followed to outcome. RESULTS: The most common AEs (≥5%) experienced by 9vHPV vaccine recipients were injection-site AEs (pain, swelling, erythema) and vaccine-related systemic AEs (headache, pyrexia). Injection-site AEs were more common in 9vHPV vaccine than qHPV vaccine recipients; most were mild-to-moderate in intensity. Discontinuations and vaccine-related serious AEs were rare (0.1% and <0.1%, respectively). Seven deaths were reported; none were considered vaccine related. The proportions of pregnancies with adverse outcome were within ranges reported in the general population. CONCLUSIONS: The 9vHPV vaccine was generally well tolerated in subjects aged 9 to 26 years with an AE profile similar to that of the qHPV vaccine; injection-site AEs were more common with 9vHPV vaccine. Its additional coverage and safety profile support widespread 9vHPV vaccination.

Original languageEnglish (US)
Article numbere20154387
JournalPediatrics
Volume138
Issue number2
DOIs
StatePublished - Aug 2016

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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    Moreira, E. D., Block, S. L., Ferris, D., Giuliano, A. R., Iversen, O. E., Joura, E. A., Kosalaraksa, P., Schilling, A., Van Damme, P., Bornstein, J., Bosch, F. X., Pils, S., Cuzick, J., Garland, S. M., Huh, W., Kjaer, S. K., Qi, H., Hyatt, D., Martin, J., ... Luxembourg, A. (2016). Safety profile of the 9-valent HPV vaccine: A combined analysis of 7 phase III clinical trials. Pediatrics, 138(2), [e20154387]. https://doi.org/10.1542/peds.2015-4387