A Dose Ranging Study Comparing Different Combinations of Adjuvanted and Non-adjuvanted Influenza Vaccines in Healthy Children 6 to <36 Months of Age
Phase 1
Completed
- Conditions
- Influenza
- Interventions
- Biological: Adjuvanted and un-adjuvanted influenza vaccines
- Registration Number
- NCT00848887
- Lead Sponsor
- Novartis
- Brief Summary
This study will evaluate the safety and immunogenicity of different combinations of influenza vaccine in healthy young children.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 410
Inclusion Criteria
- Children of 6 month to <36 month of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description 1 Adjuvanted and un-adjuvanted influenza vaccines -
- Primary Outcome Measures
Name Time Method Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment. 50 days
- Secondary Outcome Measures
Name Time Method Strain-specific influenza antibody titers will be used to assess Immunogenicity 50 days
Trial Locations
- Locations (1)
UCL St. Luc - Pharmacy
🇧🇪Brussel, Belgium