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NCT01239043 · ClinicalTrials.gov registry record · Phase 2
Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination
A Phase 2 study of Meningitis and Meningococcal Infections, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 139
- Enrollment target
- 6
- Study locations
NCT01239043: Completed Phase 2 study of Meningitis and Meningococcal Infections, sponsored by Sanofi.
NCT01239043 is a Phase 2 study of Meningitis and Meningococcal Infections that has completed, run by Sanofi. The registered enrollment target is 139 participants, below the 668-participant average among 7 other Meningitis trials with a reported enrollment target (79% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01239043, a Phase 2 study of Meningitis and Meningococcal Infections, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 139 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this trial is to describe antibody persistence and response to re-vaccination with either Menactra® or Menomune® vaccine approximately three years following initial vaccination in adults who participated in trial MTA29 (NCT00874549). Objectives: * To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination. * To evaluate persistence of serum bactericidal antibodies in subjects who received Menactra® or Menomune® vaccine approximately three years ago. * To evaluate the immune response to serogroups A, C, Y, and W-135 in subjects re-vaccinated with either Menactra® or Menomune® vaccine.
Primary Outcome
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia. Grade 3 reactions were defined as: Pain, headache, malaise, and myalgia - significant, prevents daily activity; Erythema and swelling - \> 100 mm; Fever, temperature of ≥ 39.0ºC or ≥ 102.1ºF.
Conditions Studied
Interventions
- BIOLOGICAL Menomune®: A, C, Y, W 135 Meningococcal Polysaccharide
- BIOLOGICAL Menactra®: Meningococcal (A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate
Study Locations (6)
Washington
- - Seattle
- - Spokane
Arizona
- - Scottsdale
Kentucky
- - Bardstown
New Mexico
- - Albuquerque
Utah
- - West Jordan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-02 |
| Phase | Phase 2 |
What the finished NCT01239043 record still lists
NCT01239043 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, below the 668-participant average among 7 other Meningitis trials with a reported enrollment target (79% lower).
The record links to 3 conditions, with Meningitis appearing as the primary indexed condition, and to 2 interventions - of which Menomune®: A, C, Y, W 135 Meningococcal Polysaccharide is the first listed.
NCT01239043 lists 6 locations in 5 states (Washington, Arizona, Kentucky).
Frequently Asked Questions
What is clinical trial NCT01239043 about?
NCT01239043 is a clinical study titled "Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination". The purpose of this trial is to describe antibody persistence and response to re-vaccination with either Menactra® or Menomune® vaccine approximately three years following initial vaccination in adults who participated in trial MTA29 (NCT00874549). Objectives: * To describe the rates of immediate ...
What is the current status of trial NCT01239043?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 139 participants. The study started on 2010-11. Estimated completion is 2012-02.
What conditions does trial NCT01239043 study?
This clinical trial studies the following conditions: Meningitis, Meningococcal Infections, Meningococcal Meningitis.
What interventions are being tested in trial NCT01239043?
The interventions under investigation include: Menomune®: A, C, Y, W 135 Meningococcal Polysaccharide (BIOLOGICAL), Menactra®: Meningococcal (A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate (BIOLOGICAL).
Who is sponsoring clinical trial NCT01239043?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01239043 being conducted?
This trial has 6 study locations across Arizona, Kentucky, New Mexico, Utah, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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