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Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine

NCT00258817 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-04-14

Study results available
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Summary

To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO) for characterization of circulating influenza strains.

Observational Objectives:

To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months.

To describe the immunogenicity of the 2005-2006 pediatric formulation of Fluzone vaccine, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to \< 36 months.

Conditions

Interventions

BIOLOGICAL

Influenza Virus Vaccine (Fluzone®)

0.25 mL, Intramuscular (Day 0 and Day 28)

BIOLOGICAL

Influenza Virus Vaccine (Fluzone®)

0.25 mL, Intramuscular (Day 0)

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2006-03-31
Completion
2007-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00258817 on ClinicalTrials.gov