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Completed Phase 2 Interventional Accepts healthy volunteers Results available

Post-Partum Immunization With Live Attenuated Influenza Vaccine (LAIV) or Trivalent Influenza Vaccine (TIV) in Post-Partum Breast Feeding Women

ClinicalTrials.gov ID: NCT01181323

Public ClinicalTrials.gov record NCT01181323. 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 Jul 22, 2026, 12:11 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 Randomized, Double-Blind Trial, Comparing the Safety in Mothers and Their Infants and Immunogenicity in Mothers of Live Attenuated Influenza Vaccine (LAIV) to Inactivated Trivalent Influenza Vaccine (TIV) When Administered to Breast Feeding Women

Study identification

NCT ID
NCT01181323
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Enrollment
240 participants

Conditions and interventions

Conditions

Interventions

  • Placebo Other
  • Cold-adapted live attenuated influenza virus vaccine, trivalent Biological
  • Trivalent inactivated influenza vaccine Biological

Other · Biological

Eligibility (public fields only)

Age range
18 Years to 49 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
Aug 31, 2011
Primary completion
Apr 30, 2013
Completion
Apr 30, 2013
Last update posted
Jan 27, 2015

2011 – 2013

United States locations

U.S. sites
6
U.S. states
6
U.S. cities
6
Facility City State ZIP Site status
Washington Hospital Center - Obstetrics and Gynecology Washington D.C. District of Columbia 20010-3017
Emory Children's Center - Pediatric Infectious Diseases Atlanta Georgia 30322-1014
Saint Louis University - Center for Vaccine Development St Louis Missouri 63104-1015
Duke Translational Medicine Institute - Clinical Vaccine Unit Durham North Carolina 27704-2120
Cincinnati Children's Hospital Medical Center - Infectious Diseases Cincinnati Ohio 45229-3026
Group Health Research Institute - Seattle Seattle Washington 98101-1466

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 NCT01181323, 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 27, 2015 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01181323 live on ClinicalTrials.gov.

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