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

Completed

• Conditions: Influenza; Respiratory; Influenza, virus not identified

• Registration Number: ISRCTN10483274
• Lead Sponsor: Berna Biotech Ltd, a Crucell Company (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1239

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunogenicity, assessed by haemagglutination inhibition test; blood to be collected at baseline and approximately three weeks after second dose administration.

Secondary Outcome Measures

Name	Time	Method
Safety, assessed at baseline and at three to four weeks after each vaccination, including a four-day adverse event questionnaire, soliciting a set of local and systemic adverse events (AEs).