Pregnancy and Infant Outcomes in the Clinical Trials of a Human Papillomavirus Type 6/11/16/18 Vaccine A Combined Analysis of Five Randomized Controlled Trials
Suzanne M Garland, Kevin A Ault, Stanley A Gall, Jorma Paavonen, Heather L Sings, Karen L Ciprero, Alfred Saah, Deborah Marino, Desmond Ryan, David Radley, Haiping Zhou, Richard M Haupt, Elizabeth IO Garner
OBSTETRICS AND GYNECOLOGY | LIPPINCOTT WILLIAMS & WILKINS | Published : 2009
OBJECTIVE: To present a combined analysis of the pregnancy outcomes for women aged up to 45 years enrolled in five phase III clinical studies of the prophylactic quadrivalent human papillomavirus 6/11/16/18 vaccine. METHODS: Twenty thousand five hundred fifty-one women aged 15-45 years received quadrivalent HPV vaccine or placebo at day 1 and months 2 and 6. Urine pregnancy tests were performed immediately before each injection; participants testing positive were not vaccinated. Women who became pregnant after enrollment were discontinued from further vaccination until resolution of pregnancy. All pregnancies were followed for outcomes. RESULTS: During the studies, 1,796 vaccine and 1,824 pl..View full abstract
Funded by Merck Research Laboratories.