Safety of RIV4 Versus IIV4 in Pregnant Women

PHASE4CompletedINTERVENTIONAL
Enrollment

384

Participants

Timeline

Start Date

September 5, 2019

Primary Completion Date

September 29, 2021

Study Completion Date

September 29, 2021

Conditions
SafetyAdverse Event Following ImmunisationBirth Outcomes
Interventions
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.

Trial Locations (3)

27705

Duke University Medical Center, Durham

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

02118

Boston Medical Center, Boston

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

collaborator

Boston Medical Center

OTHER

collaborator

Centers for Disease Control and Prevention

FED

lead

Duke University

OTHER

NCT03969641 - Safety of RIV4 Versus IIV4 in Pregnant Women | Biotech Hunter | Biotech Hunter