drugset
drugset / Trial / NCT01482052

Safety Study of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine for Meningitis

NCT01482052 ↗

Phase 1 Completed 60 enrolled JN-International Medical Corporation
RandomizedParallel-groupTriple-blindPrevention

Summary

The purpose of this study is to evaluate the safety of a new conjugate vaccine, NmVac4-A/C/Y/W-135-DT, compared to the safety of a similar, licensed meningococcal A/C/Y/W-135-DT conjugate vaccine. The investigators will also evaluate the production of antibodies to of NmVac4-A/C/Y/W-135-DT™ conjugate vaccine compared to the licensed vaccine, as a measure of vaccine effectiveness.

Timeline

Start
2011-11
Primary completion
2013-01
Completion
2013-01

Drugs

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

Indications

meningococcal meningitis