drugset
drugset / Trial / NCT03969641

Safety of RIV4 Versus IIV4 in Pregnant Women

NCT03969641 ↗

Phase 4 Completed 384 enrolled Duke University Boston Medical Center · collabCenters for Disease Control and Prevention · collabChildren's Hospital Medical Center, Cincinnati · collab
RandomizedParallel-groupDouble-blindPrevention

Summary

This is a prospective, randomized clinical trial. During the study, pregnant women will be randomized (1:1) to receive RIV4 or IIV4. Vaccines will be administered by licensed providers. Prior influenza vaccine history will be verified by medical record review when possible. Injection-site (local) and systemic reaction data will be assessed on vaccination day and during the 8 days following vaccination using either identical web-based or paper diaries, depending on study participant preference. Maternal serum samples will be collected for antibody titers relevant to Influenza at time points that include: prior to vaccination and \~29 days post vaccination. When feasible, maternal blood at delivery and cord blood serum will be analyzed for the same antibody titers. Pregnant women will be followed through delivery with comprehensive obstetric and neonatal outcomes obtained from medical record review for 90 days of life.

Timeline

Start
2019-09-05
Primary completion
2021-09-29
Completion
2021-09-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Flublok Quadrivalent Vaccine — —
Comparator Influenza Virus Vaccine Vaccine — —

Indications

No indication recorded.