Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01239043
The ClinicalTrials.gov registry entry for NCT01239043 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 139 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 668-participant average among 7 other Meningitis trials with a reported enrollment target (79% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
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 reports 6 study locations spanning 5 distinct geographic areas - top geographies include 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.
Learn More About Clinical Trials
Similar trials for Meningitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers
COMPLETED · Phase 2
-
Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®
COMPLETED · Phase 2
-
Hypovitaminosis D in Neurocritical Patients
COMPLETED · Phase 2
-
Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine
COMPLETED · Phase 3
-
Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Children Aged 2 to 9 Years
COMPLETED · Phase 3
-
Safety of and Immune Response to a Meningitis Vaccine in HIV-Infected Children and Youth
COMPLETED · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.