Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1) 2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 654
- Locations
- 29
- Primary Endpoint
- Antibody Responses After the First and Second Vaccinations
Study Overview
Brief Summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 6 Months to 35 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children 6 to 35 months of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months
Exclusion Criteria
- •History of serious disease.
- •History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
- •Known or suspected impairment/alteration of immune function.
- •Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination
- •For additional entry criteria, please refer to protocol
Arms & Interventions
3.75_(50)MF59
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
Intervention: MF59-eH1N1_f (Biological)
7.5_(0)MF59
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
Intervention: MF59-eH1N1_f (Biological)
7.5_(50)MF59
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
Intervention: MF59-eH1N1_f (Biological)
15_(0)MF59
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
Intervention: MF59-eH1N1_f (Biological)
Outcomes
Primary Outcomes
Antibody Responses After the First and Second Vaccinations
Time Frame: 21 days after each vaccination
CBER guidance (\<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%.
Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination
Time Frame: Day 1 to 7
Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination.
Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination
Time Frame: Day 22 to 28
Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination.
Secondary Outcomes
- Geometric Mean Titers (GMTs) Based on Baseline Seropositivity(Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination))
- Antibody Persistence by Geometric Mean Titers (GMT)(6 months (Day 202) and 12 months (Day 387) after second vaccination)
- Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010(Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination))
- Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010(Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination))
- Antibody Response Based on Baseline Seropositivity(Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination))
- Immunogenicity Measurement by Geometric Mean Titers (GMT)(21 days after each vaccination)