Preterm birth rate after bivalent HPV vaccination: Registry-based follow-up of a randomized clinical trial

A registry-based follow-up of pregnancy data until the end 2014 was conducted based on a community-randomized trial to assess human papillomavirus (HPV) vaccination strategies and reference cohort from same community with no intervention. Our objective determine whether prophylactic HPV (three doses Cervarix® (AS04-HPV-16/18)-vaccine) affects preterm birth (PTB) rates. All identified 80,272 residents in 1992–95 cohorts Finland were eligible for 20,513 39,420 (51.9%) females consented participate. The final study population consisted age-aligned 6226 HPV16/18 vaccinated 1770 HBV (Engerix® B, hepatitis B-virus vaccine) that did not receive vaccine at age 18 1992–93 cohorts, 19,849 1990–91 non-vaccinated cohorts. We compared rates (22 + 0–36 6 weeks) early 0–31 6) per term (at least 37 0) singleton births among HPV- non-HPV-vaccinated women, using nationwide Medical Birth Registry data. observed 409 first pregnancies lasting 22 0 weeks HPV-vaccinated 1923 21,619 women. In PTB rate 13/409 (3.2%) 98/1923 (5.1%) (OR 0.61, 95% CI 0.34–1.09). Early 0/409 (0%) women 20/1923 (1.0%) (p = 0.04). rate, especially lower Reduction incidence after would lead public health benefits globally. Trial Registration:NCT00534638