Trials / Completed
CompletedNCT01514708
The Safety and Immune Response to Influenza Vaccination in Pregnant Women
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Adimmune Corporation · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the antibody response to the influenza vaccine (AdimFlu-S), as measured by hemagglutination inhibition (HAI) at 4 weeks post immunization in pregnant women 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). Besides, the vaccine safety will also be evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AdimFlu-S Influenza Vaccine | Suspension for injection |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2012-06-01
- Completion
- 2012-08-01
- First posted
- 2012-01-23
- Last updated
- 2018-07-16
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT01514708. Inclusion in this directory is not an endorsement.