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COMPLETED Phase 3

Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine

NCT02752906 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 810 participants
Start Date 2016-04-15
Est. Completion 2016-12-19
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 NCT02752906

The ClinicalTrials.gov registry entry for NCT02752906 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 810 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 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. 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: NCT02752906 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Alabama, Kentucky. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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

Who is sponsoring clinical trial NCT02752906?

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 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.

Related

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