NCT03969641

Safety of RIV4 Versus IIV4 in Pregnant Women

A Prospective, Randomized, Clinical Trial to Compare Adverse Birth Outcomes in Pregnant Women Receiving Quadrivalent Recombinant Influenza Vaccine (RIV4) Versus Quadrivalent Inactivated Influenza Vaccine (IIV4)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 384 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Safety
• Adverse Event Following Immunisation
• Birth Outcomes

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent Recombinant Influenza Vaccine	The first recombinant inactivated influenza vaccine (RIV) using an insect baculovirus expression system and recombinant DNA technology
BIOLOGICAL	Quadrivalent Inactivated Influenza Vaccine	Standard inactivated influenza vaccine (IIV) manufactured involving the use of embryonated hen eggs.

Timeline

• Start date: 2019-09-05
• Primary completion: 2021-09-29
• Completion: 2021-09-29
• First posted: 2019-05-31
• Last updated: 2023-01-11
• Results posted: 2022-12-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study