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Safety of RIV4 Versus IIV4 in Pregnant Women

NCT03969641 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2023-01-11

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Geeta K Swamy, MD · Duke University

  • Karen R Broder, MD · Centers for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-05
Primary Completion
2021-09-29
Completion
2021-09-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03969641 on ClinicalTrials.gov