NCT00848887
Completed
Phase 1
A Phase Ib, Randomized, Observer-Blind, Multicenter, Factorial-Design Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Injections of Trivalent Inactivated Influenza Vaccine With or Without a Second Influenza B Strain in Combination With or Without One of Three Different Doses of Adjuvant in Healthy Children, Aged 6 to <36 Months
ConditionsInfluenza
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- Novartis
- Enrollment
- 410
- Locations
- 1
- Primary Endpoint
- Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This study will evaluate the safety and immunogenicity of different combinations of influenza vaccine in healthy young children.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.
Time Frame: 50 days
Secondary Outcomes
- Strain-specific influenza antibody titers will be used to assess Immunogenicity(50 days)
Study Sites (1)
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