• Sholom Wacholder, Bingshu Eric Chen, Allen Wilcox, George Macones, Paula Gonzalez, Brian Befano, Allan Hildesheim, Ana Cecilia Rodríguez, Diane Solomon, Rolando Herrero, Mark Schiffman, and CVT group.
• Division of Cancer Epidemiology and Genetics, National Cancer Institute, 6120 Executive Blvd, Rockville, MD 20852, USA. WacholdS@mail.nih.gov
• BMJ. 2010 Jan 1;340:c712.

ObjectiveTo assess whether vaccination against human papillomavirus (HPV) increases the risk of miscarriage.DesignPooled analysis of two multicentre, phase three masked randomised controlled trialsSettingMulticentre trials in several continents and in Costa Rica.Participants26 130 women aged 15-25 at enrolment; 3599 pregnancies eligible for analysis.InterventionsParticipants 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 MeasuresMiscarriage and other pregnancy outcomes.ResultsThe 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.ConclusionThere is no evidence overall for an association between HPV vaccination and risk of miscarriage.Trial RegistrationClinical Trials NCT00128661 and NCT00122681.

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