Risk of miscarriage with bivalent vaccine against human papillomavirus (HPV) types 16 and 18: pooled analysis of two randomised controlled trials.

ABSTRACT:

Objective

To assess whether vaccination against human papillomavirus (HPV) increases the risk of miscarriage.

Design

Pooled analysis of two multicentre, phase three masked randomised controlled trials

Setting

Multicentre trials in several continents and in Costa Rica.

Participants

26 130 women aged 15-25 at enrolment; 3599 pregnancies eligible for analysis.

Interventions

Participants were randomly assigned to receive three doses of bivalent HPV 16/18 VLP vaccine with AS04 adjuvant (n=13 075) or hepatitis A vaccine as control (n=13 055) over six months.

Main outcome measures

Miscarriage and other pregnancy outcomes.

Results

The estimated rate of miscarriage was 11.5% in pregnancies in women in the HPV arm and 10.2% in the control arm. The on

SUBMITTER: Wacholder S 

PROVIDER: S-EPMC2831171 | biostudies-literature | 2010 Mar

REPOSITORIES: biostudies-literature