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NCT04142242 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine in Older Adults Who Received a Primary Vaccination (3 or More Years Earlier) in Study MET49
A Phase 3 study of Meningococcal Infection (Healthy Volunteers), sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 471
- Enrollment target
- 20
- Study locations
NCT04142242 is a Phase 3 study of Meningococcal Infection (Healthy Volunteers) that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 471 participants. The trial reports 20 study locations across 11 states.
The verdict
NCT04142242, a Phase 3 study of Meningococcal Infection (Healthy Volunteers), has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 471 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary Objective: To demonstrate sufficiency of the vaccine seroresponse to meningococcal serogroups A, C, W, and Y following administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W 135) Tetanus Toxoid (MenACYW) Conjugate vaccine to Group 1 participants (who received primary vaccination with Menomune vaccine greater than or equal to \[\>= 3\] years earlier at \>= 56 years of age in Study MET49). Secondary Objectives: Secondary Objective 1 - To demonstrate sufficiency of the vaccine seroresponse to meningococcal serogroups A, C, W, and Y following administration of a single dose of MenACYW Conjugate vaccine to Group 2 participants (who received primary vaccination with MenACYW Conjugate vaccine \>= 3 years earlier at \>= 56 years of age in Study MET49). Secondary Objective 2 - To describe vaccine seroresponse rates with respect to serogroups A, C, W, and Y in serum specimens collected 6 days (window, 5-7) post-vaccination in approximately 60 participants from Group 1 (Menomune-primed) and approximately 60 participants from Group 2 (MenACYW Conjugate vaccine-primed). Secondary Objective 3 - To describe antibody persistence \>= 3 years after primary vaccination with Menomune vaccine or MenACYW Conjugate vaccine for participants from all groups.
Conditions Studied
Interventions
- OTHER Blood sample
- BIOLOGICAL Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Study Locations (20)
Florida
- Investigational Site Number 8400038 - Clearwater
- Investigational Site Number 8400023 - DeLand
- Investigational Site Number 8400007 - Jacksonville
- Investigational Site Number 8400015 - Jacksonville
- Investigational Site Number 8400022 - Ponte Vedra
- Investigational Site Number 8400032 - Port Orange
- Investigational Site Number 8400020 - West Palm Beach
North Carolina
- Investigational Site Number 8400021 - Greensboro
- Investigational Site Number 8400012 - Raleigh
- Investigational Site Number 8400033 - Winston-Salem
Kansas
- Investigational Site Number 8400027 - Newton
- Investigational Site Number 8400017 - Wichita
Arizona
- Investigational Site Number 8400026 - Chandler
California
- Investigational Site Number 8400003 - San Diego
Connecticut
- Investigational Site Number 8400028 - Waterbury
Louisiana
- Investigational Site Number 8400016 - Metairie
Maryland
- Investigational Site Number 8400010 - Elkridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 471 participants |
| Start Date | 2019-10-04 |
| Est. Completion | 2022-05-25 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04142242
The ClinicalTrials.gov registry entry for NCT04142242 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 471 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Meningococcal Infection (Healthy Volunteers) appearing as the primary indexed condition, and to 2 interventions - of which Blood sample is the first listed.
NCT04142242 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, North Carolina, Kansas.
Frequently Asked Questions
What is clinical trial NCT04142242 about?
NCT04142242 is a clinical study titled "Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine in Older Adults Who Received a Primary Vaccination (3 or More Years Earlier) in Study MET49". Primary Objective: To demonstrate sufficiency of the vaccine seroresponse to meningococcal serogroups A, C, W, and Y following administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W 135) Tetanus Toxoid (MenACYW) Conjugate vaccine to Group 1 participants (who rece...
What is the current status of trial NCT04142242?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 471 participants. The study started on 2019-10-04. Estimated completion is 2022-05-25.
What conditions does trial NCT04142242 study?
This clinical trial studies the following conditions: Meningococcal Infection (Healthy Volunteers).
What interventions are being tested in trial NCT04142242?
The interventions under investigation include: Blood sample (OTHER), Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04142242?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04142242 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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