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NCT00258856 · ClinicalTrials.gov registry record · Phase 2
Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®
A Phase 2 study of Meningitis and Meningococcal Infection, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 234
- Enrollment target
- 11
- Study locations
NCT00258856: Completed Phase 2 study of Meningitis and Meningococcal Infection, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00258856 is a Phase 2 study of Meningitis and Meningococcal Infection that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 234 participants, below the 654-participant average among 7 other Meningitis trials with a reported enrollment target (64% lower). The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00258856, a Phase 2 study of Meningitis and Meningococcal Infection, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 234 participants
- Enrollment target
- 11
- Study locations
Study Summary
The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 7 to 15 years (not yet 16 years) who had been vaccinated five years previously in Study 603-02. In addition, the kinetics of the antibody response will be evaluated in a subset of participants who will receive a booster dose of Menactra® vaccine and children in the same age group not previously vaccinated with a meningococcal vaccine or had meningitis disease who will receive a dose of Menactra® vaccine.
Primary Outcome
Groups 1 and 2 received booster vaccination; Groups 3 and 4 received primary vaccination. Serum bactericidal activity for the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination.
Conditions Studied
Interventions
- BIOLOGICAL Polysaccharide Diphtheria Conjugate Vaccine
Study Locations (11)
Arkansas
- - Jonesboro
- - Little Rock
Pennsylvania
- - Pittsburgh
- - Sellersville
Georgia
- - Marietta
Maryland
- - Baltimore
Massachusetts
- - Woburn
Missouri
- - Bridgeton
New York
- - Rochester
Utah
- - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 234 participants |
| Start Date | 2006-01 |
| Est. Completion | 2007-11 |
| Phase | Phase 2 |
What the finished NCT00258856 record still lists
NCT00258856 is an interventional study that assigns participants to a tested intervention. The registered 234 participants enrollment target is mid-sized for trials with a published cap, below the 654-participant average among 7 other Meningitis trials with a reported enrollment target (64% lower).
The record links to 2 conditions, with Meningitis appearing as the primary indexed condition, and to 1 intervention - of which Polysaccharide Diphtheria Conjugate Vaccine is the first listed.
NCT00258856 lists 11 locations in 9 states (Arkansas, Pennsylvania, Georgia).
Frequently Asked Questions
What is clinical trial NCT00258856 about?
NCT00258856 is a clinical study titled "Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®". The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 7 to 15 years (not yet 16 years) who had been vaccinated five years previously in Study 603-02. In addition, the kinetics of the antibody response will be evaluated in a subset of participants who will rece...
What is the current status of trial NCT00258856?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 234 participants. The study started on 2006-01. Estimated completion is 2007-11.
What conditions does trial NCT00258856 study?
This clinical trial studies the following conditions: Meningitis, Meningococcal Infection.
What interventions are being tested in trial NCT00258856?
The interventions under investigation include: Polysaccharide Diphtheria Conjugate Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00258856?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00258856 being conducted?
This trial has 11 study locations across Arkansas, Georgia, Maryland, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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