Display Settings:

Format

Send to:

Choose Destination
We are sorry, but NCBI web applications do not support your browser and may not function properly. More information
BMJ. 2010 Mar 2;340:c712. doi: 10.1136/bmj.c712.

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

Author information

  • 1Division of Cancer Epidemiology and Genetics, National Cancer Institute, 6120 Executive Blvd, Rockville, MD 20852, USA. WacholdS@mail.nih.gov

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 one sided P value for the primary analysis was 0.16; thus, overall, there was no significant increase in miscarriage among women assigned to the HPV vaccine arm. In secondary descriptive analyses, miscarriage rates were 14.7% in the HPV vaccine arm and 9.1% in the control arm in pregnancies that began within three months after nearest vaccination.

CONCLUSION:

There is no evidence overall for an association between HPV vaccination and risk of miscarriage.

TRIAL REGISTRATION:

Clinical Trials NCT00128661 and NCT00122681.

Comment in

PMID:
20197322
[PubMed - indexed for MEDLINE]
PMCID:
PMC2831171
Free PMC Article

Images from this publication.See all images (2)Free text

PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Icon for HighWire Icon for PubMed Central
    Loading ...
    Write to the Help Desk