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Clinical Trials/NCT00390884
NCT00390884CompletedPhase 4

Safety and Immunogenicity of Fluzone® Influenza Virus Vaccine (2006-2007 Formulation) Among Healthy Children Immunized in Fall 2005 With Fluzone Vaccine or Placebo

Sanofi Pasteur, a Sanofi Company5 sites in 1 country173 target enrollmentStarted: October 2006Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
173
Locations
5
Primary Endpoint
Percentage of Seroprotected Participants Post-vaccination With Fluzone®
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To compare the groups with respect to influenza immune responses following Dose 1 of Fluzone vaccine (2006-2007 formulation).

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
11 Months to 14 Months (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Percentage of Seroprotected Participants Post-vaccination With Fluzone®

Time Frame: Day 28 Post-vaccination

Seroprotection was defined as a Post-vaccination Hemagglutination Inhibition titer of greater than or equal to 1:40.

Secondary Outcomes

  • Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone®(Day 28 Post-vaccination)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (5)

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