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Completed Phase 1 Interventional Accepts healthy volunteers

A Phase I Safety and Immunogenicity Study of Mix and Match of Licensed Flu Vaccine and Flumist

ClinicalTrials.gov ID: NCT00231907

Public ClinicalTrials.gov record NCT00231907. 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 26, 2026, 2:28 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

Influenza Vaccines: Mix and Match of Trivalent Inactivated Influenza (TIV) and Live Attenuated Influenza Vaccine (LAIV), a Phase I Safety, Immunogenicity, and Viral Shedding Study

Brief summary

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

The purpose of this research is to compare the safety and ability to stimulate antibodies (part of the bodies proteins that fight infections) of two influenza (flu) vaccines given to children 12 to 35 months old. The two flu vaccines being compared are: trivalent inactivated influenza virus vaccine (TIV), a killed virus vaccine given as a shot licensed for use in children 6 months of age or older and live attenuated influenza vaccine (LAIV), a live (but weakened) virus vaccine licensed for children 5 years old and older given as a nose spray. The strains of the viruses have been weakened so that they do not cause typical influenza illness, but may allow the body to develop protection against the flu. LAIV vaccine is not licensed for children less than five years of age, therefore its use in this study is investigational. Participation is approximately 7 months in duration.

Study identification

NCT ID
NCT00231907
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
56 participants

Conditions and interventions

Conditions

Interventions

Biological

Eligibility (public fields only)

Age range
12 Months to 35 Months
Sex
All
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, 2005
Primary completion
Feb 28, 2007
Completion
Feb 28, 2007
Last update posted
Aug 26, 2010

2005 – 2007

United States locations

U.S. sites
3
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
Saint Louis University St Louis Missouri 63104 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
Vanderbilt University Nashville Tennessee 37232 —

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 NCT00231907, 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 Aug 26, 2010 · Synced Sep 26, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00231907 live on ClinicalTrials.gov.

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