A Dose Ranging Study Comparing Different Combinations of Adjuvanted and Non-adjuvanted Influenza Vaccines in Healthy Children 6 to <36 Months of Age

Phase 1

Completed

• Conditions: Influenza

• Registration Number: NCT00848887
• Lead Sponsor: Novartis

Brief Summary

This study will evaluate the safety and immunogenicity of different combinations of influenza vaccine in healthy young children.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-02-19
• Study First Submitted QC: 2009-02-19
• Study First Posted: 2009-02-20
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-23
• Last Update Posted: 2014-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 410

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.	50 days

Secondary Outcome Measures

Name	Time	Method
Strain-specific influenza antibody titers will be used to assess Immunogenicity	50 days

Trial Locations

Locations (1)

UCL St. Luc - Pharmacy; 🇧🇪 Brussel, Belgium