The Safety and Immune Response to Influenza Vaccination in Pregnant Women
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||The Safety and Immune Response to Influenza Vaccination in Pregnant Women|
- The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HAI titer ≥ 1:40. The other immunogenicity endpoints include seroconversion rate and geometric mean folds increase in HAI titer. [ Time Frame: Immunogenicity profile was assessed before vaccination, 4 weeks after the vaccination and at the end of gestation period. Moreover, the HAI titer of the cord blood was also measured and compared with the maternal blood sample. ] [ Designated as safety issue: No ]The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HAI titer ≥ 1:40. The other immunogenicity endpoints include seroconversion rate and geometric mean folds increase in HAI titer. Immunogenicity profile will be assessed before vaccination, 4 weeks after the vaccination and at the end of gestation period.
- The secondary endpoint is to evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S. [ Time Frame: The safety information is collected from the day of vaccination to 8 weeks after the delivery. ] [ Designated as safety issue: Yes ]Safety outcomes include immediate reactions at the time of vaccination, solicited local and systemic reactions for 7 days, unsolicited adverse events until the first post-vaccination serum collected (Day 28), and serious adverse events and adverse events of special interest until 8 weeks after the delivery.
|Study Start Date:||November 2011|
|Study Completion Date:||August 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
|Experimental: AdimFlu-S Influenza Vaccine, 0.5mL/dose, receive 1 dose||
Biological: AdimFlu-S Influenza Vaccine
Suspension for injection
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514708
|National Taiwan University Hospital|
|Taipei, Taiwan, 100|