Trial intelligence / Profile preview

Phase II study of two-dose adjuvanted H5N1 vaccine antigen levels in adults and elderly subjects

2009-012385-31Phase 2Completed

Sponsor
Novartis
Start
Jul 2009
Modality
Vaccines & Immunotherapeutics
Countries
1
01

Overview

Phase 2, randomised, double-blind trial of Influenza A virus A/California/7/2009 X-181 (H1N1) hemagglutinin antigen (propiolactone inactivated) in Avian Influenza (AI) (2 arms), sponsored by Novartis. Primary endpoints: Day 43 post-vaccination ratio of geometric mean titers between 3.75 microgram and 7.5 microgram groups, Immunogenicity according to CHMP criteria and 1 more. Started Jul 2009; status: completed.

02

Drugs

Influenza A virus A/California/7/2009 X-181 (H1N1) hemagglutinin antigen (propiolactone inactivated)
03

Conditions

Avian Influenza (AI)

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