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| Sponsor: | Novavax |
|---|---|
| Information provided by: | Novavax |
| ClinicalTrials.gov Identifier: | NCT00519389 |
Purpose
This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, reactogenicity, and immunogenicity of 3 potencies (dosages) of H5N1 VLP vaccine or placebo in healthy adults 18 to 40 years of age.
| Condition | Intervention | Phase |
|---|---|---|
|
Pandemic Influenza |
Biological: H5N1 VLP Influenza Vaccine |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00519389 History of Changes |
| Other Study ID Numbers: | H5N1 VLP-1 |
| Study First Received: | August 20, 2007 |
| Last Updated: | May 15, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |