At a glance
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A Phase II Study in Pregnant Women to Assess the Safety and Immunogenicity of an Unadjuvanted Sanofi Pasteur H1N1 Inactivated Influenza Vaccine Administered at Two Dose Levels
In Brief
A Phase 2 clinical trial evaluating Inactivated H1N1 Vaccine for Influenza. Completed, enrolled 120 participants across 5 sites.
Detailed Summary
The purpose of this study is to evaluate an investigational 2009 H1N1 influenza vaccine to determine vaccine safety in pregnant women and the body's immune response (body's defense against disease) to different strengths of the H1N1 influenza vaccine. In this study, 2 strengths of the H1N1 influenza vaccine will be tested (given 3 weeks apart). Participants will include approximately 120 healthy pregnant women, ages 18-39 years, in their second or third trimester of pregnancy (14-34 weeks gestation). Study procedures will include 2 doses of vaccine, blood samples, cord blood samples at delivery, and recording temperature and vaccine side effects in a memory aid for 8 days following each vaccination. Participants will be involved in study related procedures for about 7 months.
Study Details
Timeline
Interventions
Two doses of inactivated influenza H1N1 vaccine delivered intramuscularly (IM) as 15 or 30 mcg dose. The 15 mcg dose will be administered as a single 0.5 mL IM injection in the deltoid muscle of the preferred arm. The 30 mcg dose will be administered as a single 1.0 mL injection in the deltoid muscle.