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NCT02752906 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine
A Phase 3 study of Meningitis and Meningococcal Infections, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 810
- Enrollment target
- 20
- Study locations
NCT02752906: Completed Phase 3 study of Meningitis and Meningococcal Infections, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT02752906 is a Phase 3 study of Meningitis and Meningococcal Infections that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 810 participants, above the 572-participant average among 7 other Meningitis trials with a reported enrollment target (42% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02752906, a Phase 3 study of Meningitis and Meningococcal Infections, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 810 participants
- Enrollment target
- 20
- Study locations
Study Summary
The aim of the study was to describe the safety and antibody response to booster administration with Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine in participants who received their first quadrivalent meningococcal Conjugate vaccine dose in the past 4-10 years. Primary Objective: * To demonstrate the non-inferiority of the vaccine seroresponse of meningococcal serogroups A, C, Y, and W following the administration of a booster dose of MenACYW Conjugate vaccine compared to those observed following the administration of a booster dose of Menactra® in participants who were first vaccinated with 1 dose of a quadrivalent meningococcal vaccine 4 to 10 years before the booster dose. Secondary Objectives: * To evaluate the vaccine seroresponse of meningococcal serogroups A, C, Y, and W measured using human serum bactericidal assay (hSBA) in serum specimens collected 6 days after vaccination in a subset of 120 participants. * To evaluate the antibody responses (geometric mean titers) to serogroups A, C, Y, and W measured using hSBA on Day 0 (pre-vaccination) and Day 30 after vaccination. Observational Objectives: * To describe the antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA assessed at Day 0, Day 6, and Day 30 days after vaccination. * To describe the antibody responses to the meningococcal serogroups A, C, Y, and W before and 30 days after vaccination with MenACYW Conjugate vaccine or Menactra® measured by rabbit serum bactericidal assay (rSBA) in a subset of participants. * To describe the safety profile of MenACYW Conjugate vaccine compared to that of a licensed Menactra® after booster vaccination.
Primary Outcome
The serum bactericidal assay using human complement (hSBA) vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>= 1:16 for participants with pre-vaccination hSBA titers \< 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>= 1:8.
Conditions Studied
Interventions
- BIOLOGICAL Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
- BIOLOGICAL Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Study Locations (20)
California
- Investigational Site Number 005 - Downey
- Investigational Site Number 014 - La Puente
- Investigational Site Number 029 - San Diego
- Investigational Site Number 001 - San Diego
Alabama
- Investigational Site Number 016 - Birmingham
- Investigational Site Number 032 - Dothan
Kentucky
- Investigational Site Number 013 - Bardstown
- Investigational Site Number 027 - Nicholasville
Missouri
- Investigational Site Number 008 - Kansas City
- Investigational Site Number 028 - St Louis
Nebraska
- Investigational Site Number 023 - Lincoln
- Investigational Site Number 031 - Omaha
Arizona
- Investigational Site Number 026 - Mesa
Arkansas
- Investigational Site Number 022 - Jonesboro
Louisiana
- Investigational Site Number 015 - Metairie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 810 participants |
| Start Date | 2016-04-15 |
| Est. Completion | 2016-12-19 |
| Phase | Phase 3 |
What the finished NCT02752906 record still lists
NCT02752906 is an interventional study that assigns participants to a tested intervention. The registered 810 participants enrollment target is mid-sized for trials with a published cap, above the 572-participant average among 7 other Meningitis trials with a reported enrollment target (42% higher).
The record links to 3 conditions, with Meningitis appearing as the primary indexed condition, and to 2 interventions - of which Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine is the first listed.
NCT02752906 names 20 study sites across 13 states, led by California, Alabama, Kentucky.
Frequently Asked Questions
What is clinical trial NCT02752906 about?
NCT02752906 is a clinical study titled "Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine". The aim of the study was to describe the safety and antibody response to booster administration with Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine in participants who received their first quadrivalent meningococcal Conjugate vaccine dose in the pa...
What is the current status of trial NCT02752906?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 810 participants. The study started on 2016-04-15. Estimated completion is 2016-12-19.
What conditions does trial NCT02752906 study?
This clinical trial studies the following conditions: Meningitis, Meningococcal Infections, Meningococcal Meningitis.
What interventions are being tested in trial NCT02752906?
The interventions under investigation include: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (BIOLOGICAL), Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02752906?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02752906 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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