Study of Influenza Vaccine Revaccination in Healthy Adults Previously Vaccinated With Fluzone ID or Fluzone IM

Phase 2

Completed

• Conditions: Influenza
• Interventions: Biological: Influenza Virus Vaccine USP Trivalent Types A and B

• Registration Number: NCT01011049
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

The purpose of this study is to generate additional data on the immunogenicity and safety of revaccination with Fluzone Intradermal (ID) or Fluzone Intramuscular (IM) vaccine.

Primary Objective:

* To evaluate and describe the safety profile of revaccination with Fluzone ID for all participants.

Secondary Objective:

* To describe immunogenicity following revaccination with Fluzone ID or Fluzone IM.

Detailed Description

All participants, who previously received either Fluzone ID or Fluzone IM in Study FID31 (NCT 00772109), will receive one dose of either the same or the alternative vaccine.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-11-09
• Study First Submitted QC: 2009-11-10
• Study First Posted: 2009-11-11
• Disposition First Submitted: 2010-03-31
• Disposition First Submitted QC: 2010-03-31
• Disposition First Posted: 2010-04-02
• Primary Completion: 2010-05
• Study Completion: 2010-10
• Results First Submitted: 2011-07-14
• Results First Submitted QC: 2011-07-14
• Results First Posted: 2011-08-11
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1250

Inclusion Criteria

Not provided

Exclusion Criteria

A prospective subject should not be included in the study until the following conditions and/or symptoms are resolved:

• Febrile illness (temperature ≥ 37.5°C [or ≥ 99.5°F]) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
• Signs and symptoms of an acute infectious respiratory illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3: Fluzone IM After Fluzone IM	Influenza Virus Vaccine USP Trivalent Types A and B	Participants will receive Fluzone intramuscular (IM) following Fluzone IM in Study FID31
Group 4: Fluzone ID After Fluzone IM	Influenza Virus Vaccine USP Trivalent Types A and B	Participants will receive Fluzone intradermal (ID) following Fluzone intramuscular (IM) in Study FID31
Group 2: Fluzone IM After Fluzone ID	Influenza Virus Vaccine USP Trivalent Types A and B	Participants will receive Fluzone intramuscular (IM) following Fluzone ID in Study FID31
Group 1: Fluzone ID After Fluzone ID	Influenza Virus Vaccine USP Trivalent Types A and B	Participants will receive Fluzone intradermal (ID) following Fluzone ID in Study FID31

Primary Outcome Measures

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

Secondary Outcome Measures

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