Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds

PHASE2CompletedINTERVENTIONAL
Enrollment

375

Participants

Timeline

Start Date

November 15, 2017

Primary Completion Date

August 31, 2018

Study Completion Date

August 31, 2018

Conditions
Meningitis, Meningococcal
Interventions
BIOLOGICAL

Non-adjuvanted study formulation NmCV-5

Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.

BIOLOGICAL

Adjuvanted study formulation NmCV-5

Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine

BIOLOGICAL

Menactra

Menactra is available as ready to used solution containing polysacchride antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.

Trial Locations (1)

BP251

Centre pour le Développement des Vaccins du Mali, ex-Institut Marchoux, Ministry of Health, BP251, Bamako

All Listed Sponsors
collaborator

PATH

OTHER

lead

Serum Institute of India Pvt. Ltd.

INDUSTRY

NCT03295318 - Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds | Biotech Hunter | Biotech Hunter