A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Pediatric Subjects 3 to < 9 Years of Age
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- Novartis Vaccines
- Enrollment
- 1357
- Locations
- 33
- Primary Endpoint
- Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Children 3 to \< 9 years 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.
Outcomes
Primary Outcomes
Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations
Time Frame: Day 22, Day 29, Day 43, Day 202 and Day 387
HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Center for Biologics Evaluation and Research (CBER) guidance for \<65 years of age: The lower bound of the two-sided 95% Confidence Interval (CI) for the percentages of subjects achieving seroconversion for HI antibody should be ≥ 40% and the lower bound of the two-sided 95% CI for the percentages of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. Both criteria (seroconversion and HI antibody titer ≥ 40) had to be fulfilled to establish immunogenicity. PPS Day 1-29 analysis set: N= 143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F,G,and H respectively. PPS Day 1-202 analysis set: N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-387 analysis set: N= 55, 63, 61, 58, 61, 65, 59, and 63 for Groups A, B, C, D, E, F, G, and H respectively.
Secondary Outcomes
- Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group(Day 22, Day 29, Day 43, Day 202 and Day 387)
- Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.(Day 22, Day 29, Day 43)
- Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010(Day 1, Day 22, Day 29, Day 43)
- Antibody Response Based on Baseline Seropositivity(Day 22, Day 29 and Day 43)
- Geometric Mean Titers (GMTs) Based on Baseline Seropositivity(Day 1, Day 22, Day 29, Day 43)
- Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination(7 days after first vaccination)
- Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination(7 days after second vaccination)
- Number of Participants Reporting Unsolicited Adverse Events (AEs)(Safety monitoring periods were the Primary Period: Day 1 (1st vaccination) through ≤21 days post second vaccination, and the Follow-up Period: >21 Days post second vaccination to 12 months after second vaccination)