Poster presented at the 33th Annual International Society for Pharmacoepidemiology Conference
Background: Trumenba is a vaccine indicated for individuals 10 through 25 years of age to prevent invasive disease caused by Neisseria meningitidis group B (meningococcal group B disease). Since Trumenba’s indication includes women of childbearing age, Pfizer, the vaccine sponsor, has made a post-marketing commitment to conduct an observational study of the safety of Trumenba exposure during pregnancy. Because Trumenba is not indicated during pregnancy and the outcomes of interest are rare, only a multi-site study can address the study objectives in a timely manner. Post-marketing safety studies among pregnant women is an area of increasing importance that often requires complex study designs and multiple data sources; this study planning activity is an example of the approaches needed to address studies of medical product exposure during pregnancy.
Objective: Assess feasibility of conducting a post-marketing multi-site observational study with medical record review of selected outcomes among women exposed to Trumenba during pregnancy.
Methods: Counts of Trumenba exposure among women by age (15-24, 25-34, 35-49, and ≥50 years) and calendar year (November 2014- December 2016) were generated using the most recent claims data available at each partner; 16 data partners that participate in the FDA Sentinel project were invited to participate. A distributed program using the on-line Sentinel toolkit also was used to count live births among women 15-49 years of age with continuous medical and drug coverage in the 270 days after exposure.
Results: Eight partners with over 180 million covered lives in the FDA Sentinel Common Data Model format agreed to participate; data from 7 partners are included here. Using the most current data available we identified about 36,000 women with ≥1 dose of Trumenba from November 2014-December 2016; this count is independent of pregnancy or live birth. Most exposures (78%) occurred in 2016, and 89% were 15-24 years age group. Among the two data partners who ran the modular program, we identified no live births among women exposed to Trumenba.
Conclusions: A multi-site collaboration among FDA Sentinel partners was created to quickly assess feasibility of a study of outcomes among pregnant women exposed to Trumenba. There were few Trumenba exposures among women of child-bearing age, and in a subset of partners, we found no exposures in the period before live birth. Periodic monitoring to assess study feasibility should continue.
