The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in toddlers and children. 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
474
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on Day 0 and Day 21 (6 months to 35 Months)
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)
Unnamed facility
Miami Beach, Florida, United States
Unnamed facility
Marietta, Georgia, United States
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
Pre- 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 6 to 35 Months
Seroprotection: Antibody titer of ≥ 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 6 to 35 Months
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 Vaccine) Strain - Age 3 to 9 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 3 to 9 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 3 to 9 Years
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
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Unnamed facility
Woodstock, Georgia, United States
Unnamed facility
Crestview Hills, Kentucky, United States
Unnamed facility
Louisville, Kentucky, United States
Unnamed facility
Maddisonville, Kentucky, United States
Unnamed facility
Metairie, Louisiana, United States
Unnamed facility
Las Vegas, Nevada, United States
Unnamed facility
Rochester, New York, United States
Unnamed facility
Hermitage, Pennsylvania, United States
...and 10 more locations
Time frame: Pre-vaccination (Day 0) and Day 21 post-vaccination
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months
Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability.
Time frame: Days 0 to 7 post-vaccination
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months
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.
Time frame: Days 0 to 7 post-vaccination
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 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.
Time frame: Days 0 to 7 post vaccination