Trials / Completed
CompletedNCT01411358
Immunogenicity and Safety of AdimFlu-S 2011-2012 in Non-Elderly Adult and Elderly Subjects
Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2011-2012, in Non-Elderly Adult and Elderly Subjects
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 128 (actual)
- Sponsor
- Adimmune Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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 21 days 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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | non-elderly aged between 18 and 60 | one dose of 0.5mL AdimFlu-S |
| BIOLOGICAL | elderly aged over 60 | one dose of 0.5mL AdimFlu-S |
Timeline
- Start date
- 2011-08-01
- Primary completion
- 2012-03-01
- Completion
- 2012-03-01
- First posted
- 2011-08-08
- Last updated
- 2012-07-12
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT01411358. Inclusion in this directory is not an endorsement.