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

Phase 2

Completed

• Conditions: Orthomyxoviridae Infection; Influenza; Myxovirus Infection
• Interventions: Biological: Split, Inactivated, Trivalent Influenza Vaccine; Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)

• Registration Number: NCT00391391
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-10-23
• Study First Submitted QC: 2006-10-23
• Study First Posted: 2006-10-24
• Primary Completion: 2007-03
• Study Completion: 2007-10
• Disposition First Submitted: 2010-03-30
• Disposition First Submitted QC: 2010-03-31
• Disposition First Posted: 2010-04-02
• Results First Submitted: 2011-10-12
• Results First Submitted QC: 2011-10-12
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-21
• Results First Posted: 2011-11-22
• Last Update Posted: 2011-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Split, Inactivated, Trivalent Influenza Vaccine	Split, Inactivated, Trivalent Influenza Vaccine
2	Split, Inactivated, Trivalent Influenza Vaccine	Split, Inactivated, Trivalent Influenza Vaccine
3	Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)	Split, Inactivated, Trivalent Influenza Vaccine
4	Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)	Split, Inactivated, Trivalent Influenza Vaccine

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Day 0 and Day 28 post-vaccination	Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Day 28 post-vaccination	Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Day 28 post-vaccination	Seroprotection was defined as participants achieving a post-dose antibody titers ≥40.; Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine	Day 28 post-vaccination	Seroconversion was defined as the conversion to a post-vaccination titer of ≥ 40 for subjects with pre-vaccination titer \< 10, or at least a 4-fold increase in post vaccination titer for subjects with pre vaccination titer ≥ 10.
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.	Day 0 to Day 7 post-vaccination	Solicited injection site reactions: Tenderness, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability.
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds	Day 0 to Day 7 post-vaccination	Solicited injection site reactions: Pain, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia.