Novartis H1N1 Vaccine in Pregnant Women
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This page only displays public information reproduced from the official ClinicalTrials.gov record NCT00992719. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.
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Official title
A Phase II Study In Pregnant Women to Assess the Safety and Immunogenicity of an Unadjuvanted Novartis H1N1 Inactivated Influenza Vaccine Administered at Two Dose Levels
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00992719
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 84 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 39 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2009 (Type not available)
- Primary completion
- Feb 2011 (Actual)
- Completion
- Feb 2011 (Actual)
- Last update posted
- Aug 7, 2013
2009 – 2011
United States locations
- U.S. sites
- 6
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Maryland Baltimore | Baltimore | Maryland | 21201 | — |
| Saint Louis University - Center for Vaccine Development | St Louis | Missouri | 63104 | — |
| Duke University Medical Center | Durham | North Carolina | 27705 | — |
| Vanderbilt University | Nashville | Tennessee | 37232-2573 | — |
| Baylor College of Medicine - Department of Molecular Virology and Microbiology | Houston | Texas | 77030 | — |
| Group Health Cooperative | Seattle | Washington | 98101 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00992719, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 7, 2013 · Synced Nov 15, 2026
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