A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years
- Conditions
- InfluenzaSwine-origin A/H1N1 Influenza
- Registration Number
- NCT00952419
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
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.
- Detailed Description
Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 474
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months Pre-vaccination (Day 0) and 21 days post-vaccination Pre- and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months 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 ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years 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.
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years 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.
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months Days 0 to 7 post-vaccination Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability.
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months 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.
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months Pre-vaccination (Day 0) and Day 21 post-vaccination Seroprotection: Antibody titer of ≥ 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 3 to 9 Years 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 ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years Pre-vaccination (Day 0) and 21 days post-vaccination Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
- Secondary Outcome Measures
Name Time Method