Assessment of the immunogenicity and safety of the Northern Hemisphere 2008/2009-season influenza vaccine in elderly and young subjects according to European Medicines Agency (EMEA) regulations

Completed

• Conditions: Influenza; Infections and Infestations; Influenza, virus not identified

• Registration Number: ISRCTN40098615
• Lead Sponsor: Crucell, Berna Biotech Ltd (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-22
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Healthy female and male volunteers equal to or older than 18 years of age
2. Written informed consent

Exclusion Criteria

1. Pregnancy and lactation
2. Serious adverse reaction to any influenza vaccine

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 before and approximately three weeks after vaccination.

Secondary Outcome Measures

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