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NCT00643916 · ClinicalTrials.gov registry record · Phase 2
Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age
A Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 378
- Enrollment target
NCT00643916: Completed Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00643916 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 378 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (184% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00643916, a Phase 2 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 378 participants
- Enrollment target
Study Summary
The purpose of this clinical trial is to describe the safety and immunogenicity of one or two doses of Menactra® (TetraMenD) administered in children less than 2 years of age. Primary Objective: To describe the immunogenicity profile of one or two doses of Menactra® (TetraMenD) when administered to subjects aged 9, 12, 15, or 18 months in comparison to the immunogenicity of one dose of Menomune® when administered to children aged 3 years to \<6 years of age.
Interventions
- BIOLOGICAL Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 378 participants |
| Start Date | 2004-12 |
| Est. Completion | 2007-10 |
| Phase | Phase 2 |
What the finished NCT00643916 record still lists
NCT00643916 is an interventional study that assigns participants to a tested intervention. The registered 378 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (184% higher).
The record links to 0 conditions, and to 1 intervention - of which Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®) is the first listed.
NCT00643916 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00643916 about?
NCT00643916 is a clinical study titled "Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age". The purpose of this clinical trial is to describe the safety and immunogenicity of one or two doses of Menactra® (TetraMenD) administered in children less than 2 years of age. Primary Objective: To describe the immunogenicity profile of one or two doses of Menactra® (TetraMenD) when administered t...
What is the current status of trial NCT00643916?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 378 participants. The study started on 2004-12. Estimated completion is 2007-10.
What interventions are being tested in trial NCT00643916?
The interventions under investigation include: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00643916?
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 NCT00643916's enrollment target sits among peer trials
378 115th of 2000 higher than 1,886 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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