Immunogenicity and Safety of Multiple Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adult and Elderly Subjects
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Enrollment
- 849
- Primary Endpoint
- Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine.
Primary Objectives:
- To describe the immunogenicity of the candidate vaccines after each injection.
- To describe the safety of the candidate vaccines after each injection.
Detailed Description
Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Time Frame: Pre-vaccination (Day 0) and day 21 post-vaccination
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Time Frame: Pre-vaccination (Day 0) and Day 21 post-vaccination
Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Time Frame: Pre-vaccination (Day 0) and 21 days post-vaccination
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years
Time Frame: Pre-vaccination (Day 0) and 21 days post-vaccination
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Time Frame: Days 0 to 7 post-vaccination
Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills).
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Time Frame: Days 0 to 7 post-vaccination
Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills).
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years
Time Frame: Pre-vaccination (Day 0) and 21 days post-vaccination
Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years
Time Frame: Pre-vaccination (Day 0) and 21 days post-vaccination
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.