Novartis H1N1 Vaccine in Pregnant Women

Summary

The purpose of this study is to evaluate the safety of a 2009 H1N1 influenza vaccine in pregnant women and to determine how their body reacts to different strengths of the vaccine. Two strengths of the H1N1 influenza vaccine will be tested. Since it is not known if the response to the vaccine in pregnant women is the same or different than in non-pregnant women, the study also includes a group of women who are not pregnant for comparison. Participants include 200 pregnant women and 100 non-pregnant women ages 18-39. Study procedures include physical exams, several blood samples and maintaining a memory aid to document daily temperature and side effects for 8 days following vaccination. Participants will be involved in study related procedures for about 6 months.

Timeline

Start

2009-11

Primary completion

2011-02

Completion

2011-02

Publications

• Kansara D, Kosikova M, Milletich PL, Zhou J, Coughlan L, Zens MS, Swamy G, Hoen AG, Xie H, Ackerman ME, Pasetti MF; DMID 09-0072 Clinical Study Group. Increased dose of H1N1 pandemic influenza vaccine during pregnancy improves immunity in mothers and infants. mBio. 2026 Apr 8;17(4):e0390425. doi: 10.1128/mbio.03904-25. Epub 2026 Mar 17.

Drugs

Indications