ISRCTN10483274
Completed
Not Applicable
Assessment of the immunogenicity and safety of the Northern Hemisphere 2009/2010-season influenza vaccine in children aged 6 to 35 months in comparison to a commercially available influenza vaccine: an observer-blind, randomised, controlled, safety/immunogenicity study
Berna Biotech Ltd, a Crucell Company (Switzerland)0 sites1,239 target enrollmentOctober 20, 2009
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- Berna Biotech Ltd, a Crucell Company (Switzerland)
- Enrollment
- 1239
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy children (male or female) aged 6 to 35 months
- •2\. Written informed consent
Exclusion Criteria
- •1\. Previous influenza vaccination
- •2\. Serious adverse reaction to any influenza vaccine
- •3\. Medical treatment with immune suppressant or immune modulating drugs
- •4\. Presentation of clinical symptoms of active infection and/or body temperature greater than or equal to 38°C
Outcomes
Primary Outcomes
Not specified
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