Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
5536402 | Vaccine | 2017 | 6 Pages |
Abstract
The pharmacovigilance plan to investigate the effects of inadvertent exposure to AS04-HPV-16/18 vaccine during pregnancy included assessment of pregnancy outcomes among women enrolled in clinical trials, evaluation of pregnancy exposure reports from all countries as part of routine passive safety surveillance, a large, well conducted post-authorization observational study, and the pregnancy registry. These registry data complement other data from clinical trials and post-marketing surveillance showing no evidence that vaccination with AS04-HPV-16/18 during the defined exposure period (within 60Â days before conception until delivery) increases the risk of teratogenicity.
Keywords
Related Topics
Life Sciences
Immunology and Microbiology
Immunology
Authors
Marta López-Fauqued, Julia Zima, Maria-Genalin Angelo, Jens-Ulrich Stegmann,