Influenza Clinical Trial
Official title:
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
Verified date | April 2017 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children
Status | Completed |
Enrollment | 654 |
Est. completion date | December 2010 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 35 Months |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Novartis Vaccines | Novartis |
United States, Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Antibody Responses After the First and Second Vaccinations | 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%. | 21 days after each vaccination | |
Primary | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination. | Day 1 to 7 | |
Primary | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination. | Day 22 to 28 | |
Secondary | Immunogenicity Measurement by Geometric Mean Titers (GMT) | Immunogenicity was measured in terms of the GMT at 21 days after each vaccination. | 21 days after each vaccination | |
Secondary | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines. | Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) | |
Secondary | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines. | Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) | |
Secondary | Antibody Response Based on Baseline Seropositivity | Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer = 1:10 | Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) | |
Secondary | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer = 1:10 Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer = 1:10) at Baseline (Day 1 (pre-vaccination)) as compared to those who are seronegative (HI titer < 1:10). | Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) | |
Secondary | Antibody Persistence by Geometric Mean Titers (GMT) | Immunogenicity was assessed in terms of Geometric Mean Titers (GMT at 6 months (Day 202)and 12 months (Day 387) after second vaccination. | 6 months (Day 202) and 12 months (Day 387) after second vaccination |
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