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Completed Phase 2 Interventional Accepts healthy volunteers Results available

Influenza Vaccine in Pregnant Women

ClinicalTrials.gov ID: NCT00905125

Public ClinicalTrials.gov record NCT00905125. 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 Sep 2, 2026, 6:35 PM 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 Randomized, Double-Blind Trial on the Safety and Immunogenicity of Inactivated Trivalent Influenza Vaccine in Pregnant Women

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

In pregnant women, flu may cause complications like pneumonia (infection of the lungs) or hospitalization. In the United States (US) it is recommend that all women get flu vaccine if they are going to be pregnant or deliver during the flu season but only a few studies have measured a pregnant woman's immune response (the body's defense against the flu) after getting the flu vaccine. About 200, 18-39 year old, inclusive, pregnant women in their second or third trimester (from 14 weeks of gestation to term, inclusive) will be enrolled in this US based study. Participation will be about 8 months in duration. Women will be randomized (assigned by chance) to receive either Fluzone® or Fluarix®. Blood collection will occur on Day 0 and 28 days post vaccination.

Study identification

NCT ID
NCT00905125
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
102 participants

Conditions and interventions

Conditions

Interventions

Biological

Eligibility (public fields only)

Age range
18 Years to 39 Years
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
May 31, 2009
Primary completion
Feb 28, 2010
Completion
Feb 28, 2010
Last update posted
Jun 12, 2012

2009 – 2010

United States locations

U.S. sites
9
U.S. states
9
U.S. cities
9
Facility City State ZIP Site status
Emory University School of Medicine - Gynecology and Obstetrics Atlanta Georgia 30322
University of Iowa Iowa City Iowa 52242
University of Maryland Baltimore Baltimore Maryland 21201
Mayo Clinic, Rochester - Vaccine Research Group Rochester Minnesota 55905
Saint Louis University St Louis Missouri 63104
Duke University Medical Center Durham North Carolina 27705
Vanderbilt University Nashville Tennessee 37232-2573
Baylor College of Medicine - Molecular Virology and Microbiology Houston Texas 77030
Group Health Cooperative Seattle Washington 98101

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 NCT00905125, 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 Jun 12, 2012 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00905125 live on ClinicalTrials.gov.

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