Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults

Phase 3

Completed

• Conditions: Orthomyxoviridae Infection; Myxovirus Infection; Influenza
• Interventions: Biological: Influenza Virus Vaccine USP Trivalent Types A and B

• Registration Number: NCT00772109
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

This study is designed to test lot consistency of three different manufacturing lots and to generate safety and immunogenicity data of the investigational vaccine administered via the ID route.

Primary Objective:

* To demonstrate lot consistency of the Fluzone ID manufacturing process.

* To provide information concerning the immune response of Fluzone ID.

Secondary Objectives:

Safety

* To describe the safety profile of subjects who receive of Fluzone ID.

Detailed Description

Three lots of the investigational Fluzone vaccine with the 2008/2009 Northern Hemisphere formulation will be administered intradermally (ID) using the Becton Dickinson Micro Injection System.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-13
• Study First Submitted QC: 2008-10-13
• Study First Posted: 2008-10-15
• Primary Completion: 2009-05
• Study Completion: 2009-07
• Disposition First Submitted: 2010-03-31
• Disposition First Submitted QC: 2010-03-31
• Disposition First Posted: 2010-04-02
• Results First Submitted: 2011-07-16
• Results First Submitted QC: 2011-07-16
• Results First Posted: 2011-08-10
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4292

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluzone Intradermal Vaccine Lot 1	Influenza Virus Vaccine USP Trivalent Types A and B	Participants will receive a dose of Influenza intradermal vaccine Lot 1
Fluzone Intradermal Vaccine Lot 2	Influenza Virus Vaccine USP Trivalent Types A and B	Participants will receive a dose of Influenza intradermal vaccine Lot 2
Fluzone Intradermal Vaccine Lot 3	Influenza Virus Vaccine USP Trivalent Types A and B	Participants will receive a dose of Influenza intradermal vaccine Lot 3
Fluzone Intramuscular Vaccine	Influenza Virus Vaccine USP Trivalent Types A and B	Participants will receive a dose of influenza intramuscular vaccine

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved Seroconversion Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine	28 Days post-vaccination	The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay.; Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and post-vaccination titer of ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum of four-fold increase 28 days post-vaccination.
Geometric Mean Titers (GMTs) at Baseline and Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccines	Baseline (Day 0) and 28 Days post-vaccination	The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved Seroprotection Pre- and Post-vaccination With Either Fluzone ID or Fluzone IM	Before and 28 Days post-vaccination	The serological determinations of anti influenza antibodies was by Hemagglutination Inhibition (HAI) assay.; Seroprotection was defined as a HAI antibody titer ≥ 1:40.
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine	Day 0 up to 7 Days post vaccination	Solicited injection site reactions: Ecchymosis, Erythema, Induration, Pain, Pruritus, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.