Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00905125 · ClinicalTrials.gov registry record · Phase 2
Influenza Vaccine 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
- 102
- Enrollment target
- 9
- Study locations
NCT00905125: Completed Phase 2 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00905125 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 102 participants, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00905125, 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
- 102 participants
- Enrollment target
- 9
- Study locations
Study Summary
In pregnant women, flu may cause complications like pneumonia (infection of the lungs) or hospitalization. In the United States (US) it is recommend that all women get flu vaccine if they are going to be pregnant or deliver during the flu season but only a few studies have measured a pregnant woman's immune response (the body's defense against the flu) after getting the flu vaccine. About 200, 18-39 year old, inclusive, pregnant women in their second or third trimester (from 14 weeks of gestation to term, inclusive) will be enrolled in this US based study. Participation will be about 8 months in duration. Women will be randomized (assigned by chance) to receive either Fluzone® or Fluarix®. Blood collection will occur on Day 0 and 28 days post vaccination.
Primary Outcome
Blood was collected for HAI assay at Day 0 prior to vaccination and again at 28 days following vaccination. The HAI assay was conducted with the three antigens in the 2008-2009 seasonal inactivated TIV: Influenza B antigen, H1N1 antigen, and H3N2 antigen.
Conditions Studied
Interventions
- BIOLOGICAL Fluzone®
- BIOLOGICAL Fluarix®
Study Locations (9)
Georgia
- Emory University School of Medicine - Gynecology and Obstetrics - Atlanta
Iowa
- University of Iowa - Iowa City
Maryland
- University of Maryland Baltimore - Baltimore
Minnesota
- Mayo Clinic, Rochester - Vaccine Research Group - Rochester
Missouri
- Saint Louis University - St Louis
North Carolina
- Duke University Medical Center - Durham
Tennessee
- Vanderbilt University - Nashville
Texas
- Baylor College of Medicine - Molecular Virology and Microbiology - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2009-06 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
What the finished NCT00905125 record still lists
NCT00905125 is an interventional study that assigns participants to a tested intervention. The registered 102 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 2 interventions - of which Fluzone® is the first listed.
NCT00905125 lists 9 locations in 9 states (Georgia, Iowa, Maryland).
Frequently Asked Questions
What is clinical trial NCT00905125 about?
NCT00905125 is a clinical study titled "Influenza Vaccine in Pregnant Women". In pregnant women, flu may cause complications like pneumonia (infection of the lungs) or hospitalization. In the United States (US) it is recommend that all women get flu vaccine if they are going to be pregnant or deliver during the flu season but only a few studies have measured a pregnant woman'...
What is the current status of trial NCT00905125?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2009-06. Estimated completion is 2010-03.
What conditions does trial NCT00905125 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT00905125?
The interventions under investigation include: Fluzone® (BIOLOGICAL), Fluarix® (BIOLOGICAL).
Who is sponsoring clinical trial NCT00905125?
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 NCT00905125 being conducted?
This trial has 9 study locations across Georgia, Iowa, Maryland, Minnesota, Missouri. 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 NCT00905125's enrollment target sits among peer trials
102 101st of 156 higher than 56 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
-
High vs. Standard Dose Influenza Vaccines in Lung Transplant (Repeater)
RECRUITING · Phase 2
-
Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients
RECRUITING · Phase 2
-
High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients
RECRUITING · Phase 2
-
Systems Investigation of Vaccine Responses in Aging and Frailty
RECRUITING · Phase 2
-
High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients
RECRUITING · Phase 2
-
High vs. Standard Dose Influenza Vaccine in Adult SOT Recipients
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03704662 · 102 participants · NA
Preoperative Fractionated Radiation Therapy Versus Stereotactic Body Radiation Therapy for Resectable or Borderline Resectable, or Locally Advanced Type A Pancreatic Adenocarcinoma
- NCT04174742 · 102 participants
Self Reported Pain in Women While Undergoing Treatment for Non-metastatic Breast Cancer
- NCT04275362 · 102 participants
Gait Analysis of a Lateral-Pivot Design Total Knee Replacement
- NCT04541082 · 102 participants · Phase 1
Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia