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NCT00384397 · ClinicalTrials.gov registry record · Phase 3
A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers
A Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,128
- Enrollment target
NCT00384397: Completed Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00384397 is a Phase 3 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 1,128 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00384397, a Phase 3 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,128 participants
- Enrollment target
Study Summary
This is a Phase III, modified single-blind, randomized, parallel-group, multicenter, comparative trial in the United States designed to evaluate the immunogenicity and safety of two doses of Menactra vaccine administered alone, and concomitantly with other routine pediatric vaccines typically administered between 12 and 15 months of age. Primary Objective: To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135. Secondary Objectives: Immunogenicity * To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with Hib and MMRV vaccines. * To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with PCV vaccine. Safety \- To describe the safety profile within 7 and 30 days of each vaccination, and serious adverse events (SAEs) throughout the course of the study.
Interventions
- BIOLOGICAL Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
- BIOLOGICAL Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,128 participants |
| Start Date | 2006-09 |
| Est. Completion | 2009-02 |
| Phase | Phase 3 |
What the finished NCT00384397 record still lists
NCT00384397 is an interventional study that assigns participants to a tested intervention. Its 1,128 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% higher).
The record links to 0 conditions, and to 2 interventions - of which Meningococcal Polysaccharide Diphtheria Toxoid Conjugate is the first listed.
NCT00384397 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00384397 about?
NCT00384397 is a clinical study titled "A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers". This is a Phase III, modified single-blind, randomized, parallel-group, multicenter, comparative trial in the United States designed to evaluate the immunogenicity and safety of two doses of Menactra vaccine administered alone, and concomitantly with other routine pediatric vaccines typically admini...
What is the current status of trial NCT00384397?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,128 participants. The study started on 2006-09. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00384397?
The interventions under investigation include: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (BIOLOGICAL), Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00384397?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00384397's enrollment target sits among peer trials
1,128 247th of 2000 higher than 1,754 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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