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NCT00992719 · ClinicalTrials.gov registry record · Phase 2
Novartis H1N1 Vaccine in Pregnant Women
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
NCT00992719 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 84 participants.
The verdict
NCT00992719, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL Inactivated H1N1 Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2009-11 |
| Est. Completion | 2011-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00992719
The ClinicalTrials.gov registry entry for NCT00992719 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Inactivated H1N1 Vaccine is the first listed.
NCT00992719 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00992719 about?
NCT00992719 is a clinical study titled "Novartis H1N1 Vaccine in Pregnant Women". 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 pre...
What is the current status of trial NCT00992719?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2009-11. Estimated completion is 2011-02.
What interventions are being tested in trial NCT00992719?
The interventions under investigation include: Inactivated H1N1 Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00992719?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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