Pooled analysis of large and long-term safety data from the human papillomavirus-16/18-AS04-adjuvanted vaccine clinical trial programme.
Bottom Line: Coadministration did not change the overall safety profile.No new safety signals were identified.The data confirm previous findings that HPV-16/18-vaccine has an acceptable benefit-risk profile in adolescent girls and adult women.
Affiliation: GlaxoSmithKline Vaccines, Wavre, Belgium.Show MeSH
Related in: MedlinePlus
Mentions: Information on pregnancy outcomes was calculated for two risk windows (Figure 1): (1) pregnancies with onset ‘around vaccination’ defined as occurring in women that reported the date of onset of their last menstrual period as during the risk period between 30 days before and 45 days after each vaccination; (2) pregnancies with exposure at any time defined as exposures occurring from 60 days before pregnancy onset (defined as the date of onset of the last menstrual period + 14 days) until the end of pregnancy.