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| Sponsor: | Novavax |
|---|---|
| Information provided by: | Novavax |
| ClinicalTrials.gov Identifier: | NCT00754455 |
Purpose
A Phase 2a Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine (recombinant) in Healthy Adults.
Study Objectives:
Primary:
Secondary:
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: Influenza VLP Vaccine (recombinant) High Dose Biological: Influenza VLP Vaccine (recombinant) Middle Dose Biological: Influenza VLP Vaccine (recombinant) Low Dose Biological: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | A Phase 2a Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine (Recombinant) in Healthy Adults |
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2008 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
High Dose
|
Biological: Influenza VLP Vaccine (recombinant) High Dose
High dose Vaccine as a single injection of 0.5 mL.
|
|
Experimental: 2
Middle Dose
|
Biological: Influenza VLP Vaccine (recombinant) Middle Dose
Middle dose Vaccine as a single injection of 0.5 mL.
|
|
Experimental: 3
Low Dose
|
Biological: Influenza VLP Vaccine (recombinant) Low Dose
Low dose Vaccine as a single injection of 0.5 mL.
|
|
Placebo Comparator: 4
Placebo Control
|
Biological: Placebo
Placebo as a single injection of 0.5 mL.
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Study Design:
This is a Phase 2a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and immunogenicity of three dose levels (low, middle or high) of Influenza VLP Vaccine or placebo in healthy adults(18 to 49 years of age).
Eligible subjects will provide a blood sample for baseline evaluation of immunological measures followed by a single intramuscular (IM) injection of Influenza VLP Vaccine or placebo (Day 1).
Subjects will be monitored in the clinic for a period of at least 30 minutes following vaccination for the occurrence of adverse events including local injection site reactions and systemic responses. For 7 days following vaccination and beginning the day of vaccination, subjects will maintain a symptom diary for daily recording of injection-site reactions as well as generalized systemic reactions including measurement of body temperature. Clinic staff will contact the subjects by telephone 2 days post vaccination (Day 3) to check for adverse events and to answer any questions related to collection of symptom diary information. Subjects will return to the clinic 7 days following vaccination (Day 8) for safety evaluation that will include a review of diary card information. A subset of subjects will additionally return to the clinic 10-14 days following vaccination (Days 11-15) to provide a blood sample for evaluation of cell-mediated immune (CMI) responses. All subjects will return to the clinic 21 days following injection (Day 22) for a safety evaluation and to provide a blood sample for measurement of humoral immunological parameters. A final safety evaluation (telephone contact) will occur at approximately 6 months following vaccination (Day 181).
The study will be conducted as a parallel group design with a total of approximately 300 subjects (18 to 49 years of age) randomly assigned to one of 4 treatment arms (high, middle, low and placebo) in a 2:2:1:1 ratio. The following is a summary of subject allocation to treatment:
Subject Allocation Treatment Condition Number of Subjects High dose vaccine/ 0.5 mL - 100 Middle dose vaccine/ 0.5 mL - 100 Low dose vaccine/ 0.5 mL - 50 Placebo (0.5 mL) - 50
Eligibility| Ages Eligible for Study: | 18 Years to 49 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| University Clinical Research | |
| Pembroke Pines, Florida, United States, 33024 | |
| United States, Missouri | |
| The Center for Pharmacuetical Research | |
| Kansas City, Missouri, United States, 64114 | |
| United States, Rhode Island | |
| Omega Medical Research | |
| Warwick, Rhode Island, United States, 02886 | |
| United States, Texas | |
| Benchmark Research | |
| Austin, Texas, United States, 78705 | |
| Principal Investigator: | John E Ervin, M.D. | The Center for Pharmaceutical Research |
| Principal Investigator: | Laurence Chu, M.D. | Benchmark Research |
| Principal Investigator: | Larry Gilderman, D.O. | University Clinical Research |
| Principal Investigator: | David L Freid, M.D. | Omega Medical Research |
More Information
| Responsible Party: | Novavax - Executive Director, Clinical Research, Novavax, Inc. |
| ClinicalTrials.gov Identifier: | NCT00754455 History of Changes |
| Other Study ID Numbers: | NVX 755.201 |
| Study First Received: | September 16, 2008 |
| Last Updated: | October 6, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |