Safety and Immunogenicity of Trivalent Split Influenza Vaccine Using the Strain Composition 2007/2008

Phase 3

Completed

• Conditions: Seasonal Influenza; Vaccine

• Registration Number: NCT00498303
• Lead Sponsor: Novartis

Brief Summary

Annual trial for registration of trivalent split influenza vaccine with the strain composition of the season 2007/2008 in healthy adult and elderly subjects

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-07-09
• Study First Submitted QC: 2007-07-09
• Study First Posted: 2007-07-10
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-21
• Last Update Posted: 2008-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
• available for all the visits scheduled in the study and able to comply with all study requirements
• in good health as determined by: medical history, physical examination, clinical judgment of the investigator

Exclusion Criteria

• n/a

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
evaluate the antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21
evaluate safety of trivalent split influenza vaccine

Trial Locations

Locations (1)

Werksarztzentrum Herborn; 🇩🇪 Herborn, Germany