MedTrace Logo

Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older

NCT01732627 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2022-04-04

Study results available
· View outcomes & findings →

Summary

Primary objectives:

* To describe the antibody responses to meningococcal serogroups A, C, Y, and W 135, measured by serum bactericidal assay using human complement (hSBA) and baby rabbit complement (rSBA), induced by a single dose of Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein (MenACYW) Conjugate vaccine or Menomune® - A/C/Y/W 135.
* To describe the safety profile of a single dose of MenACYW Conjugate vaccine or Menomune® - A/C/Y/W 135.

Conditions

  • Meningitis
  • Meningococcal Meningitis
  • Meningococcal Infections
  • Invasive Meningococcal Disease

Interventions

BIOLOGICAL

Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate Vaccine

0.5 milliliter (mL), Intramuscular (IM)

BIOLOGICAL

Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W 135 Combined

0.5 mL, Subcutaneous (SC)

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
56 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-12
Primary Completion
2013-01-17
Completion
2013-01-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01732627 on ClinicalTrials.gov