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NCT01442675 · ClinicalTrials.gov registry record · Phase 2
Study of a Single Dose of Menactra® Vaccine 4-6 Years After Prior Menactra Vaccine
A Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 834
- Enrollment target
NCT01442675 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 834 participants.
The verdict
NCT01442675, a Phase 2 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 834 participants
- Enrollment target
Study Summary
The purpose of this trial is to describe the safety and antibody response to revaccination with Menactra vaccine in persons who received their first dose at ≥11 years of age. Primary Objective: \- To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, measured by serum bactericidal assay using human complement (SBA-HC), induced by Menactra vaccine in subjects who were first vaccinated with Menactra 4-6 years ago. Secondary Objective: \- To evaluate the antibody responses to serogroups A, C, Y, and W-135 in serum specimens collected 6 days post-vaccination in a subset of study population. Observational Objective: \- To describe the rates of immediate reactions, solicited injection-site and systemic reactions, unsolicited adverse events and serious adverse events following vaccination.
Interventions
- BIOLOGICAL Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 834 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01442675
The ClinicalTrials.gov registry entry for NCT01442675 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 834 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 1 intervention - of which Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra® is the first listed.
NCT01442675 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01442675 about?
NCT01442675 is a clinical study titled "Study of a Single Dose of Menactra® Vaccine 4-6 Years After Prior Menactra Vaccine". The purpose of this trial is to describe the safety and antibody response to revaccination with Menactra vaccine in persons who received their first dose at ≥11 years of age. Primary Objective: \- To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, measured by serum ...
What is the current status of trial NCT01442675?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 834 participants. The study started on 2011-09. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01442675?
The interventions under investigation include: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra® (BIOLOGICAL).
Who is sponsoring clinical trial NCT01442675?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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