drugset / Trial / NCT01897402

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

NCT01897402 ↗

Phase 2 Completed 525 enrolled JN-International Medical Corporation
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Meningococcal (Groups A,C,Y,W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine Vaccine 0.5 ml Intramuscular
Subject NmVac4-A/C/Y/W-135-DT™ Vaccine 0.5 ml Intramuscular