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Sponsors and Collaborators: |
Novartis Novartis Vaccines |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00434733 |
This study is designed to evaluate the immunogenicity, safety and tolerability of 2 doses of FLUAD-H5N1 vaccine compared to 2 doses of trivalent, interpandemic FLUAD, each administered 3 weeks apart.
Condition | Intervention | Phase |
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Influenza |
Biological: Pandemic influenza vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety Study |
Official Title: | A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Poland | |
Centrum Badań Farmakologii Klinicznej monipol | |
Kraków, Poland, 30-969 |
Study Chair: | Novartis Vaccines and Diagnostics GmbH & Co KG Novartis | Novartis Vaccines and Diagnostics GmbH & Co KG., Germany |
Study ID Numbers: | V87P4, 2006-005428-18 |
Study First Received: | February 12, 2007 |
Last Updated: | April 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00434733 History of Changes |
Health Authority: | Poland: Central Register of Clinical Trials (CEBK) |
Influenza H5N1, pandemic |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Influenza, Human Influenza in Birds Orthomyxoviridae Infections |
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |