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.
Participants will receive a single injection of their randomized vaccine on Day 0.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
548
0.5 mL, Intramuscular on Day 0
0.5 mL, Intramuscular on Day 0
0.5 mL, Intramuscular on Day 0
Unnamed facility
Anaheim, California, United States
Unnamed facility
Fountain Valley, California, United States
Unnamed facility
South Miami, Florida, United States
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
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.
Time frame: 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
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).
Time frame: Day 0 and Day 21 post-vaccination
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
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Time frame: Day 0 and Day 21 post-vaccination
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
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti-HA antibody titer was defined as titers ≥ 10 (1/dil).
Time frame: 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 ≥ 65 Years
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).
Time frame: Day 0 and Day 21 post-vaccination
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0.5 mL, Intramuscular on Day 0
0.5 mL, Intramuscular on Day 0
Unnamed facility
Springfield, Missouri, United States
Unnamed facility
Rochester, New York, United States
Unnamed facility
Raleigh, North Carolina, United States
Unnamed facility
Cincinnati, Ohio, United States
Unnamed facility
Cleveland, Ohio, United States
Unnamed facility
Grove City, Pennsylvania, United States
Unnamed facility
Jefferson Hills, Pennsylvania, United States
...and 5 more locations
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
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Time frame: Day 0 and Day 21 post-vaccination
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
Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering
Time frame: Day 0 up to Day 7 post-vaccination
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
Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.
Time frame: Day 0 up to Day 7 post-vaccination