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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: Completed Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT01442675 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 834 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (527% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC)
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 |
What the finished NCT01442675 record still lists
NCT01442675 is an interventional study that assigns participants to a tested intervention. The registered 834 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 (527% higher).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01442675's enrollment target sits among peer trials
834 36th of 2000 higher than 1,965 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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