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NCT01173211 · ClinicalTrials.gov registry record · Phase 2
2010-2011 Trivalent Influenza Vaccine (TIV) in Pregnant Women
A Phase 2 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 183
- Enrollment target
- 5
- Study locations
NCT01173211: Completed Phase 2 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01173211 is a Phase 2 study of Influenza that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 183 participants, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01173211, a Phase 2 study of Influenza, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 183 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study is to see how much antibody (proteins produced by the immune system that help fight infections) the body makes after getting a flu vaccine. Researchers will also look at how the body reacts to the flu vaccine and how it affects the babies of pregnant women. The study will enroll approximately 240 women ages 18-39 years, including 180 pregnant women in their second or third trimester of pregnancy (at least 14 weeks pregnant) and 60 non-pregnant women. Participants will be randomly (by chance) assigned to 1 of 3 vaccine groups. Each participant will receive one shot of a 2010-2011 flu season licensed vaccine. The vaccine will be given as an intramuscular injection (shot in the muscle) in the upper arm. Study procedures include pregnancy testing, blood draws, and memory aids. Patient participation may be up to 8 months. The information from this study will help guide researchers in developing flu vaccines for pregnant women.
Primary Outcome
Unsolicited non-serious adverse events were collected from participants at follow up contacts, either by phone or in clinic, through 28 days after vaccination. Association to vaccination was determined by a clinician licensed to make a medical diagnosis and listed on the site's Federal Drug Administration's Form 1572.
Conditions Studied
Interventions
- BIOLOGICAL Trivalent inactivated influenza vaccine
Study Locations (5)
Missouri
- Saint Louis University - Center for Vaccine Development - St Louis
North Carolina
- Duke University Medical Center - Duke Perinatal Clinic - Durham
Tennessee
- Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center - Nashville
Texas
- Baylor College of Medicine - Molecular Virology and Microbiology - Houston
Washington
- Group Health Research Institute - Seattle - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2010-09 |
| Est. Completion | 2011-11 |
| Phase | Phase 2 |
What the finished NCT01173211 record still lists
NCT01173211 is an interventional study that assigns participants to a tested intervention. The registered 183 participants enrollment target is mid-sized for trials with a published cap, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 1 intervention - of which Trivalent inactivated influenza vaccine is the first listed.
NCT01173211 lists 5 locations in 5 states (Missouri, North Carolina, Tennessee).
Frequently Asked Questions
What is clinical trial NCT01173211 about?
NCT01173211 is a clinical study titled "2010-2011 Trivalent Influenza Vaccine (TIV) in Pregnant Women". The purpose of this study is to see how much antibody (proteins produced by the immune system that help fight infections) the body makes after getting a flu vaccine. Researchers will also look at how the body reacts to the flu vaccine and how it affects the babies of pregnant women. The study will e...
What is the current status of trial NCT01173211?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 183 participants. The study started on 2010-09. Estimated completion is 2011-11.
What conditions does trial NCT01173211 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT01173211?
The interventions under investigation include: Trivalent inactivated influenza vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01173211?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01173211 being conducted?
This trial has 5 study locations across Missouri, North Carolina, Tennessee, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01173211's enrollment target sits among peer trials
183 84th of 156 higher than 73 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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