Study of Meninigococcal Conjugate Vaccine Containing Serogroups A,C,Y,W and X (MCV5) in Healthy Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

August 1, 2016

Primary Completion Date

October 13, 2017

Study Completion Date

October 13, 2017

Conditions
Meningococcal Vaccines
Interventions
BIOLOGICAL

Adjuvanted MCV-5

Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM), and 125 μg Al3+adjuvant.

BIOLOGICAL

Non-Adjuvanted MCV-5

Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, and 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM).

BIOLOGICAL

Menactra®

Menactra® vaccine was a clear to slightly turbid solution supplied in a 0.5 mL single dose vial. Each 0.5 mL dose of vaccine was formulated in sodium phosphate buffered isotonic sodium chloride solution to contain four mcg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 μg of diphtheria toxoid protein carrier and residual amounts of formaldehyde of less than 2.66 μg (0.000532%), by calculation.

Trial Locations (1)

21201

Center for Vaccine Development, Baltimore

All Listed Sponsors
lead

PATH

OTHER

NCT02810340 - Study of Meninigococcal Conjugate Vaccine Containing Serogroups A,C,Y,W and X (MCV5) in Healthy Adults | Biotech Hunter | Biotech Hunter