ClinicalTrials.gov record
Completed Phase 1 Interventional Accepts healthy volunteers

Comparison of Flu Vaccine Doses in Children

ClinicalTrials.gov ID: NCT01164553

Public ClinicalTrials.gov record NCT01164553. 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 Apr 29, 2026, 12:46 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, Phase I Study Comparing an Increased Dose(s) (0.5 ml) of Trivalent Inactivated Influenza Vaccine (TIV) With Standard Dose(s) (0.25 ml) TIV in Children 6-35 Months of Age

Study identification

NCT ID
NCT01164553
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Enrollment
243 participants

Conditions and interventions

Conditions

Interventions

  • Trivalent Inactivated Influenza Vaccine Biological

Biological

Eligibility (public fields only)

Age range
6 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
Sep 30, 2010
Primary completion
Sep 30, 2012
Completion
Sep 30, 2012
Last update posted
Apr 28, 2013

2010 – 2012

United States locations

U.S. sites
7
U.S. states
6
U.S. cities
6
Facility City State ZIP Site status
Emory Children's Center - Pediatric Infectious Diseases Atlanta Georgia 30322-1014
Emory University School of Medicine - Emory Children's Center - Pediatric Infectious Diseases Atlanta Georgia 30322
University of Iowa - Infectious Disease Clinic Iowa City Iowa 52242-1009
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore Baltimore Maryland 21201-1509
Saint Louis University - Center for Vaccine Development St Louis Missouri 63104-1015
Cincinnati Children's Hospital Medical Center - Infectious Diseases Cincinnati Ohio 45231
Vanderbilt University - Pediatric - Infectious Diseases 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 NCT01164553, 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 Apr 28, 2013 · Synced Apr 29, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01164553 live on ClinicalTrials.gov.

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