Influenza Vaccine Revaccination in Ambulatory Elderly Subjects

Phase 2

Completed

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

• Registration Number: NCT00775450
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years.

Primary Objective:

To describe the safety profile for all subjects.

Secondary Objective:

To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.

Detailed Description

Subjects who previously participated in study FID29 will be invited to participate in this revaccination study. They will be assigned to 1 of 3 groups based on the group they were previously randomized to and the vaccine received in study FID29.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-16
• Study First Submitted QC: 2008-10-16
• Study First Posted: 2008-10-20
• Primary Completion: 2009-06
• 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: 2011-07-14
• Results First Submitted QC: 2011-07-14
• Results First Posted: 2011-08-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-05
• Last Update Posted: 2013-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 807

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1b: Fluzone IM After Fluzone ID	Influenza Virus Vaccine USP Trivalent Types A and B	-
Group 2a: Fluzone IM After Fluzone IM	Influenza Virus Vaccine USP Trivalent Types A and B	-
Group 2b: Fluzone ID After Fluzone IM	Influenza Virus Vaccine USP Trivalent Types A and B	-
Group 3: Fluzone HD After Fluzone HD	Influenza Virus Vaccine USP Trivalent Types A and B	-
Group 1a: Fluzone ID After Fluzone ID	Influenza Virus Vaccine USP Trivalent Types A and B	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection	Days 0 through 7 post vaccination	Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering.

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection	Day 0 and Day 28 post-vaccination	Serum antibody titers for the influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.
Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine	Day 28 post vaccination	Seroconversion was defined as either a pre-vaccination hemagglutinin inhibition (HAI) titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre- vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post vaccination.
Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine	Days 0 and 28 post-vaccination	Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28.