Ignite Creation Date:
2024-05-05 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 9:55 AM
Study NCT ID:
NCT00754455
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2008-09-16
Brief Title:
Evaluate the Safety and Immunogenicity of a Seasonal Influenza VLP Vaccine Recombinant in Healthy Adults
Sponsor:
Novavax
Organization:
Novavax
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
To assess the tolerability and safety of Influenza VLP Vaccine
To assess the immunogenicity of Influenza VLP Vaccine as measured by hemagglutination inhibition HAI antibody titers to each of the three component viral strains
Secondary
To evaluate the cross-strain immunogenicity of Influenza VLP Vaccine as measured by hemagglutination inhibition HAI antibody titers against drifted strains
To quantify antibody against neuraminidase and hemagglutinin following administration of Influenza VLP Vaccine
To assess cell-mediated immune CMI responses to Influenza VLP Vaccine as quantified by interferon-gamma IFNg and Granzyme-B produced by peripheral blood mononuclear cells PBMCs
Study Objectives
Primary
To assess the tolerability and safety of Influenza VLP Vaccine
To assess the immunogenicity of Influenza VLP Vaccine as measured by hemagglutination inhibition HAI antibody titers to each of the three component viral strains
Secondary
To evaluate the cross-strain immunogenicity of Influenza VLP Vaccine as measured by hemagglutination inhibition HAI antibody titers against drifted strains
To quantify antibody against neuraminidase and hemagglutinin following administration of Influenza VLP Vaccine
To assess cell-mediated immune CMI responses to Influenza VLP Vaccine as quantified by interferon-gamma IFNg and Granzyme-B produced by peripheral blood mononuclear cells PBMCs
Detailed Description:
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 adults18 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 2211 ratio The following is a summary of subject allocation to treatment
Subject Allocation Treatment Condition Number of Subjects High dose vaccine 05 mL - 100 Middle dose vaccine 05 mL - 100 Low dose vaccine 05 mL - 50 Placebo 05 mL - 50
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 adults18 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 2211 ratio The following is a summary of subject allocation to treatment
Subject Allocation Treatment Condition Number of Subjects High dose vaccine 05 mL - 100 Middle dose vaccine 05 mL - 100 Low dose vaccine 05 mL - 50 Placebo 05 mL - 50
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None