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NCT00355121 · ClinicalTrials.gov registry record · Phase 2
Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 882
- Enrollment target
NCT00355121: Completed Phase 2 study, sponsored by Sanofi.
NCT00355121 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 882 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (563% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00355121, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 882 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and DAPTACEL® vaccine. The main objectives are: Immunogenicity: To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTACEL® compared to when either vaccine is given alone. Safety: To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are administered concomitantly compared to when each vaccine is given alone.
Primary Outcome
Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.
Interventions
- BIOLOGICAL Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 882 participants |
| Start Date | 2006-10 |
| Est. Completion | 2009-07 |
| Phase | Phase 2 |
What the finished NCT00355121 record still lists
NCT00355121 is an interventional study that assigns participants to a tested intervention. The registered 882 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 (563% higher).
The record links to 0 conditions, and to 1 intervention - of which Polysaccharide Diphtheria Toxoid Conjugate Vaccine is the first listed.
NCT00355121 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00355121 about?
NCT00355121 is a clinical study titled "Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®". The purpose of this study is to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and DAPTACEL® vaccine. The main objectives are: Immunogenicity: To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTA...
What is the current status of trial NCT00355121?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 882 participants. The study started on 2006-10. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00355121?
The interventions under investigation include: Polysaccharide Diphtheria Toxoid Conjugate Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00355121?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00355121's enrollment target sits among peer trials
882 33rd of 2000 higher than 1,968 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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