The Safety and Immune Response to Influenza Vaccination in Pregnant Women

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.

Timeline

Start

2011-11

Primary completion

2012-06

Completion

2012-08

Publications

• Lin SY, Wu ET, Lin CH, Shyu MK, Lee CN. The safety and immunogenicity of trivalent inactivated influenza vaccination: a study of maternal-cord blood pairs in Taiwan. PLoS One. 2013 Jun 6;8(6):e62983. doi: 10.1371/journal.pone.0062983. Print 2013.

Drugs

Indications