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NCT00777257 · ClinicalTrials.gov registry record · Phase 4
Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine
A Phase 4 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,345
- Enrollment target
NCT00777257 is a Phase 4 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 1,345 participants.
The verdict
NCT00777257, a Phase 4 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,345 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years. Primary Objective: To determine whether concomitant administration of two vaccines, Tdap and Menactra®, induces antibody responses that are similar to those observed when each vaccine is given separately. Secondary Objective: To compare the rates of injection site reactions at the Tdap injection site after Tdap and Menactra® vaccines are administered concomitantly to the corresponding rates of reactions when Tdap vaccine is administered alone.
Interventions
- BIOLOGICAL T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.
- BIOLOGICAL Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.
- BIOLOGICAL Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,345 participants |
| Start Date | 2005-04 |
| Est. Completion | 2007-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00777257
The ClinicalTrials.gov registry entry for NCT00777257 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,345 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj. is the first listed.
NCT00777257 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00777257 about?
NCT00777257 is a clinical study titled "Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine". The purpose of this study was to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years. Primary Objective: To determine whether concomitant administration of two vaccines, Tdap and Menactra®, induces antibo...
What is the current status of trial NCT00777257?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,345 participants. The study started on 2005-04. Estimated completion is 2007-09.
What interventions are being tested in trial NCT00777257?
The interventions under investigation include: T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj. (BIOLOGICAL), Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj. (BIOLOGICAL), Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap (BIOLOGICAL).
Who is sponsoring clinical trial NCT00777257?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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