Format

Send to

Choose Destination
Pediatrics. 2016 Aug;138(2). pii: e20154387. doi: 10.1542/peds.2015-4387. Epub 2016 Jul 15.

Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials.

Author information

1
Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Bahia, Brazil; edson@bahia.fiocruz.br.
2
Kentucky Pediatric/Adult Research, Inc, Bardstown, Kentucky;
3
Department of Medicine, Medical College of Georgia, Augusta University, Augusta, Georgia;
4
Center for Infection Research in Cancer, Moffitt Cancer Center, Tampa, Florida;
5
Department of Gynaecology, University of Bergen, Bergen, Norway;
6
Department of Obstetrics, Medical University of Vienna, Vienna, Austria;
7
Department of Medicine, Khon Kaen University, Khon Kaen, Thailand;
8
Departamento de Ginecología y Obstetricia Clínica Alemana, Facultad de Medicina Clínica Alemana-Universidad Del Desarrollo, Santiago, Chile;
9
Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium;
10
Department of Obstetrics and Gynecology, Galilee Medical Center and Bar Ilan University Faculty of Medicine, Nahariya, Israel;
11
Catalan Institute of Oncology/IDIBELL, Barcelona, Spain;
12
Wolfson Institute of Preventive Medicine, London, United Kingdom;
13
Royal Women's Hospital, University of Melbourne and Murdoch Childrens Research Institute, Parkville, Australia;
14
Division of Gynecologic Oncology, University of Alabama Birmingham, Birmingham, Alabama;
15
Danish Cancer Society Research Center and Department of Gynecology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark;
16
Merck & Co., Inc., Kenilworth, New Jersey; and.
17
Sanofi Pasteur MSD, Lyon, France.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00543543 NCT00943722 NCT01651949 NCT00988884 NCT01047345 NCT01073293 NCT01304498.

PMID:
27422279
DOI:
10.1542/peds.2015-4387
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for HighWire
Loading ...
Support Center