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COMPLETED 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

NCT04142242 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 471 participants
Start Date 2019-10-04
Est. Completion 2022-05-25
Phase Phase 3

Sponsor

Sanofi Pasteur, a Sanofi Company

43 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 43 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04142242 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, North Carolina, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04142242?

This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 43 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial