ClinicalTrials.gov record
Completed Phase 4 Interventional Accepts healthy volunteers Results available

Safety of RIV4 Versus IIV4 in Pregnant Women

ClinicalTrials.gov ID: NCT03969641

Public ClinicalTrials.gov record NCT03969641. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 18, 2026, 12:29 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Study identification

NCT ID
NCT03969641
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Duke University
Other
Enrollment
384 participants

Conditions and interventions

Interventions

  • Quadrivalent Inactivated Influenza Vaccine Biological
  • Quadrivalent Recombinant Influenza Vaccine Biological

Biological

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 4, 2019
Primary completion
Sep 28, 2021
Completion
Sep 28, 2021
Last update posted
Jan 10, 2023

2019 – 2021

United States locations

U.S. sites
3
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
Boston Medical Center Boston Massachusetts 02118
Duke University Medical Center Durham North Carolina 27705
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03969641, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 10, 2023 · Synced May 18, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03969641 live on ClinicalTrials.gov.

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