- * Pregnancy women pregnant women aged 18 years or older within the US who were immunized with the Flucelvax vaccine at any time during pregnancy.The registry will allow eligible pregnant women to selfenroll and also allow HCPs to report de-identified data on pregnancy exposures and outcomes.
- * Sufficient evidence to confirm that Flucelvax exposure occurred during pregnancy
- * Sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (ie, whether the outcome of pregnancy was known at the time of first contact with the registry)
- * Date the pregnancy exposure is registered
- * Full reporter (ie, HCP) contact information to allow for follow-up (name, address,etc) The primary population for analysis will include prospectively enrolled pregnancies exposed to Flucelvax that are not lost to follow-up (ie, with outcome information that meet the minimum criteria for evaluation)
Pregnant Women, Influenza
Flucelvax Pregnancy Registry
NCT02258178 | PHASE 2 | OBSERVATIONAL
The goal of the registry is to develop a better understanding of the safety of Flucelvax in women and their offspring who were exposed to the vaccine during pregnancy
Trial Information
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PPD
Wilmington,North Carolina,United States,28401
Study Eligibility Criteria
Additional Studies
Additional studies can be found at ClinicalTrials.gov