Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2012-2013, in Non-Elderly Adult and Elderly Subjects
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- Adimmune Corporation
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Immunogenicity endpoint: Seroprotection rate
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HAI) at three weeks post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males or non-pregnant females and aged ≥ 18 years;
- •Willing and able to adhere to visit schedules and all study requirements;
- •Subjects read and signed the study-specific informed consent.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Immunogenicity endpoint: Seroprotection rate
Time Frame: At 3 weeks after vaccination
Seroprotection rate is defined as the proportion of subjects with HAI titer ≥ 1:40.
Immunogenicity endpoint: Seroconversion rate
Time Frame: At 3 weeks after vaccination
The seroconversion is defined as the HAI titer of the post-vaccination serum is at least 1:40 for those who had a negative pre-vaccination HAI serum titer or a four-fold or greater increase in HAI titers in subjects who had a positive pre-vaccination HAI serum titer. The seropositive is defined as the HAI titer ≥ 1:10, and the seronegative is defined as HAI titer \< 1:10.
Immunogenicity endpoint: Geometric mean folds increase in HAI titer
Time Frame: At 3 weeks after vaccination
Secondary Outcomes
- Safety: Reactogenicity events(7 days after vaccination)
- Safety: Serious and non-serious adverse events(Through day 21 post vaccination)