A Study of Different Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly

Phase 2

Completed

• Conditions: Influenza; Swine-origin A/H1N1 Influenza
• Interventions: Biological: Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant; Biological: Monovalent Subvirion A/H1N1 influenza vaccine; Biological: Normal saline solution

• Registration Number: NCT00952276
• Lead Sponsor: Sanofi

Brief Summary

The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in adults and the elderly.

Primary Objectives:

* To describe the immunogenicity of the candidate vaccines after a single injection.

* To describe the safety of the candidate vaccines after a single injection.

Detailed Description

Participants will receive a single injection of their randomized vaccine on Day 0.

Study Timeline

• Study First Submitted: 2009-08-03
• Study First Submitted QC: 2009-08-03
• Study First Posted: 2009-08-06
• Study Start: 2009-10
• Primary Completion: 2010-12
• Study Completion: 2011-03
• Status Verified: 2011-08
• Results First Submitted: 2011-08-26
• Results First Submitted QC: 2011-08-26
• Last Update Submitted: 2011-08-26
• Results First Posted: 2011-10-03
• Last Update Posted: 2011-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 548

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A/H1N1 Vaccine Group 1	Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant	Participants will receive A/H1N1 vaccine formulation 1 (with adjuvant)
A/H1N1 Vaccine Group 2	Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant	Participants will receive A/H1N1 vaccine formulation 2 (with adjuvant)
A/H1N1 Vaccine Group 3	Monovalent Subvirion A/H1N1 influenza vaccine	Participants will receive A/H1N1 vaccine formulation 3
A/H1N1 Vaccine Group 4	Monovalent Subvirion A/H1N1 influenza vaccine	Participants will receive A/H1N1 vaccine formulation 4
Placebo Group 5	Normal saline solution	Participants will receive a placebo vaccine

Primary Outcome Measures

Name	Time	Method
Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years	Day 0 and Day 21 post-vaccination	Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti HA antibody titer was defined as titers ≥ 10 (1/dilution) on Day 0 and Day 21 post-vaccination.
Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years	Day 0 and Day 21 post-vaccination	Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).
Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years	Day 0 and Day 21 post-vaccination	Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years	Day 0 and Day 21 post-vaccination	Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti-HA antibody titer was defined as titers ≥ 10 (1/dil).
Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years	Day 0 and Day 21 post-vaccination	Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).
Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years	Day 0 and Day 21 post-vaccination	Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years	Day 0 up to Day 7 post-vaccination	Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years	Day 0 up to Day 7 post-vaccination	Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.