CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 525 enrolled
Drug / intervention
Test Vaccine +1 morebiological
Likely dose
Test Vaccine 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01897402
NCT01897402Phase 2Completed
CompareCT.gov

A Phase 2 Double Blind Study to Evaluate Safety and Immunogenicity of Meningococcal Meningitis Serogroups A, C, Y & W-135 Polysaccharide Diphtheria Toxoid Conjugate Vaccine (NmVac4-A/C/Y/W-135-DT™) Compared With a Licensed Vaccine

JN-International Medical Corporation·interventional·Posted Jul 12, 2013·Updated Apr 23, 2015

In Brief

A Phase 2 clinical trial evaluating Test Vaccine and US Licensed Vaccine for Meningococcal Meningitis and Meningococcal Infections. Completed, enrolled 525 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Meningitis, Meningococcal Infections
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 12, 2013
Enrollment StartJul 1, 2013
Primary CompletionMay 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.0 years ago

Interventions

Test Vaccinebiological

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.

US Licensed Vaccinebiological

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.