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.
Panozzo CA, Purcell B, Andrade S, Griffin MR, Haynes K, Lin ND, McMahill-Walraven CN, Naleway A, Young J, Brown JS, Stark J. Safety of Trumenba Vaccine Among Pregnant Women in the United States: Planning and Design of a Large-Scale Multi-Site Observational Study. 33rd Annual International Society for Pharmacoepidemiology Conference; 2017 Aug 22; Montreal, Canada.
