Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Adult Subjects
Phase 2
Completed
- Conditions
- Influenza
- Interventions
- Biological: Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine
- Registration Number
- NCT00996138
- Lead Sponsor
- Novartis Vaccines
- Brief Summary
This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy adults based on EMEA/CHMP criteria, and safety \& tolerability.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Healthy Japanese adults aged 20 to 60 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
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine Dose ranging Arm 1 Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine Dose ranging
- Primary Outcome Measures
Name Time Method Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6 6 weeks
- Secondary Outcome Measures
Name Time Method AEs, vital signs, laboratory tests 6 weeks
Trial Locations
- Locations (1)
Osaka pref.
🇯🇵Kagoshima pref., Japan