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 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.
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 26 participants or records.
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