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Immunogenicity and Safety of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine

NCT01897402 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 525

Last updated 2015-04-23

Study results available
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Summary

The purpose of this study is to evaluate the production of antibodies to a new conjugate vaccine, NmVac4-A/C/Y/W-135-DT, as a measure of vaccine effectiveness, compared to the production of antibodies to a similar, licensed meningococcal (Groups A, C, Y, W-135) polysaccharide diphtheria toxoid (DT) conjugate vaccine. The investigators will also evaluate the safety of NmVac4-A/C/Y/W-135-DT™ conjugate vaccine compared to the licensed vaccine. The hypothesis is that the test vaccine is comparable to the licensed active control vaccine.

Conditions

  • Meningococcal Meningitis
  • Meningococcal Infections

Interventions

BIOLOGICAL

Test Vaccine

NmVac4-A/C/Y/W-135-DT™ conjugate is a vaccine in liquid form composed of purified polysaccharides (PS) conjugated to diphtheria toxoid. Single intramuscular 0.5 mL dose contains 4 µg each of Serogroup A, C, W-135, and Y PS conjugated to approximately 26 µg total diphtheria toxoid.

BIOLOGICAL

US Licensed Vaccine

Meningococcal (Groups A,C,Y,W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine 0.5 mL dose, intramuscular. Single dose contains 4 µg each Serogroup A, C, W-135 and Y conjugated to approximately 48 µg total diphtheria toxoid.

Sponsors & Collaborators

  • JN-International Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Alberto Yataco, MD · IRC Clinics,

  • Jeffrey E Atkinson, MD · Chesapeake Research Group

  • Myron I Murdock, MD · Mid Atlantic Urology Associates LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-05-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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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 NCT01897402 on ClinicalTrials.gov