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https://www.arca.fiocruz.br/handle/icict/18860
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ArticleCopyright
Open access
Embargo date
2017-08-31
Sustainable Development Goals
03 Saúde e Bem-EstarCollections
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SAFETY PROFILE OF THE 9-VALENT HPV VACCINE: A COMBINED ANALYSIS OF 7 PHASE III CLINICAL TRIALS
Author
Moreira Júnior, Edson Duarte
Block, Stan L
Ferris, Daron
Giuliano, Anna R
Iversen, Ole-Erik
Joura, Elmar A
Kosalaraksa, Pope
Schilling, Andrea
Van Damme, Pierre
Bornstein, Jacob
Bosch, F Xavier
Pils, Sophie
Cuzick, Jack
Garland, Suzanne M
Huh, Warner
Kjaer, Susanne K
Qi, Hong
Hyatt, Donna
Martin, Jason
Moeller, Erin
Ritter, Michael
Baudin, Martine
Luxembourg, Alain
Block, Stan L
Ferris, Daron
Giuliano, Anna R
Iversen, Ole-Erik
Joura, Elmar A
Kosalaraksa, Pope
Schilling, Andrea
Van Damme, Pierre
Bornstein, Jacob
Bosch, F Xavier
Pils, Sophie
Cuzick, Jack
Garland, Suzanne M
Huh, Warner
Kjaer, Susanne K
Qi, Hong
Hyatt, Donna
Martin, Jason
Moeller, Erin
Ritter, Michael
Baudin, Martine
Luxembourg, Alain
Affilliation
Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil
Múltipla - ver em Notas
Múltipla - ver em Notas
Abstract
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.
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