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Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children

NCT00391391 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2011-12-01

Study results available
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Summary

Primary Objective:

To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.

Secondary Objectives:

* To describe the immunogenicity of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.
* To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.

Conditions

  • Orthomyxoviridae Infection
  • Influenza
  • Myxovirus Infection

Interventions

BIOLOGICAL

Split, Inactivated, Trivalent Influenza Vaccine

Vaccine (infant dose)

BIOLOGICAL

Split, Inactivated, Trivalent Influenza Vaccine

Vaccine (children dose)

BIOLOGICAL

Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)

Vaccine (infant dose)

BIOLOGICAL

Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)

Vaccine (children dose)

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00391391 on ClinicalTrials.gov