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.
Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
849
0.5 mL, Intramuscular on Day 0 and on Day 21
0.5 mL, Intramuscular on Day 0 and Day 21
0.5 mL, Intramuscular on Day 0 and day 21
Unnamed facility
Hoover, Alabama, United States
Unnamed facility
Chandler, Arizona, United States
Unnamed facility
Phoenix, Arizona, United States
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Time frame: Pre-vaccination (Day 0) and day 21 post-vaccination
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Time frame: Pre-vaccination (Day 0) and Day 21 post-vaccination
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Time frame: Pre-vaccination (Day 0) and 21 days post-vaccination
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Time frame: Pre-vaccination (Day 0) and 21 days post-vaccination
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years
Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Time frame: Pre-vaccination (Day 0) and 21 days post-vaccination
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
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0.5 mL, Intramuscular on Day 0 and Day 21
Unnamed facility
Anaheim, California, United States
Unnamed facility
South Miami, Florida, United States
Unnamed facility
Maddisonville, Kentucky, United States
Unnamed facility
Springfield, Missouri, United States
Unnamed facility
Raleigh, North Carolina, United States
Unnamed facility
Cincinnati, Ohio, United States
Unnamed facility
Cleveland, Ohio, United States
...and 5 more locations
Time frame: Pre-vaccination (Day 0) and 21 days post-vaccination
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
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).
Time frame: Days 0 to 7 post-vaccination
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
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).
Time frame: Days 0 to 7 post-vaccination