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NCT03077438 · ClinicalTrials.gov registry record · Phase 3
Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Children Aged 2 to 9 Years
A Phase 3 study of Meningitis and Meningococcal Infections, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,000
- Enrollment target
- 20
- Study locations
NCT03077438: Completed Phase 3 study of Meningitis and Meningococcal Infections, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT03077438 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 1,000 participants, above the 545-participant average among 7 other Meningitis trials with a reported enrollment target (83% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03077438, 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
- 1,000 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study was to evaluate the immunogenicity and describe the safety of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®) vaccine in children 2 to 9 years of age in the United States (US) and Puerto Rico. Primary objective: \- To demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine compared to that observed following the administration of a single dose of MENVEO® in children aged 2 to 9 years. Secondary objectives: * To compare the serum bactericidal assay using human complement (hSBA) antibody geometric mean titers (GMTs) of meningococcal serogroups A, C, Y, and W following the administration of MenACYW Conjugate vaccine to those observed following the administration of MENVEO® in children 2 to 9 years of age. * To evaluate the hSBA antibody GMTs of meningococcal serogroups A, C, Y, and W following the administration of MenACYW Conjugate vaccine and those observed following the administration of MENVEO® in children 2 to 5 years of age, and in children 6 to 9 years of age, respectively. * To evaluate the hSBA vaccine seroresponse to meningococcal serogroups A, C, Y, and W before and 30 days (+14 days) post-vaccination in children 2 to 5 years of age, and in children 6 to 9 years of age, respectively. Observational objective: \- To describe the safety profile of MenACYW Conjugate vaccine and that of the licensed MENVEO®.
Primary Outcome
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titers greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titers less than (\<) 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
- BIOLOGICAL Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
Study Locations (20)
California
- Investigational Site - Anaheim
- Investigational Site - Downey
- Investigational Site - Paramount
- Investigational Site - San Diego
Ohio
- Investigational Site - Cincinnati
- Investigational Site - Cleveland
- Investigational Site - Dayton
- Investigational Site - Fairfield
Alabama
- Investigational Site - Birmingham
- Investigational Site - Dothan
Kentucky
- Investigational Site - Bardstown
- Investigational Site - Nicholasville
Missouri
- Investigational Site - Bridgeton
- Investigational Site - Kansas City
Arizona
- Investigational Site - Tucson
Arkansas
- Investigational Site - Jonesboro
Iowa
- Investigational Site - Council Bluffs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2017-02-17 |
| Est. Completion | 2017-10-10 |
| Phase | Phase 3 |
What the finished NCT03077438 record still lists
NCT03077438 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 545-participant average among 7 other Meningitis trials with a reported enrollment target (83% 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 is the first listed.
NCT03077438 names 20 study sites across 11 states, led by California, Ohio, Alabama.
Frequently Asked Questions
What is clinical trial NCT03077438 about?
NCT03077438 is a clinical study titled "Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Children Aged 2 to 9 Years". The purpose of the study was to evaluate the immunogenicity and describe the safety of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®) vacc...
What is the current status of trial NCT03077438?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,000 participants. The study started on 2017-02-17. Estimated completion is 2017-10-10.
What conditions does trial NCT03077438 study?
This clinical trial studies the following conditions: Meningitis, Meningococcal Infections, Meningococcal Meningitis.
What interventions are being tested in trial NCT03077438?
The interventions under investigation include: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate (BIOLOGICAL), Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03077438?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03077438 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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