A Multi-center, Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Doses of Adjuvanted Cell-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Japanese Pediatric Subjects
Phase 2
- Conditions
- swine-origin Influenza A H1N1 Virus
- Registration Number
- JPRN-jRCT2080221032
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Healthy Japanese aged 6 months to 19 years
Exclusion Criteria
- History of anaphylaxis, serious vaccine reactions, hypersensitivity to vaccine viral proteins or excipients
- Administration of adjuvanted influenza vaccine or suspected influenza disease within 3 month prior to study start
- Administration of any other vaccines within 4 weeks prior to enrollment expect for seasonal influenza vaccines within 1 week
- History of progressive or severe neurological disorders
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6
- Secondary Outcome Measures
Name Time Method AEs, vital signs, laboratory tests