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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 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 882 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00355121
The ClinicalTrials.gov registry entry for NCT00355121 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 882 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Polysaccharide Diphtheria Toxoid Conjugate Vaccine is the first listed.
NCT00355121 reports 0 study locations.
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.
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