This observer-blind, randomized, active controlled trial will be conducted among 2-29 year olds in two sites (Mali and The Gambia). The objectives of the study are to assess and compare the immunogenicity and safety of NmCV-5 with that of Menactra. A total of 1800 eligible participants (who or their parents/guardians have given written informed consent) will be randomised 2:1 (NmCV-5: Menactra) in each of the three age strata 18-29 years, 11-17 years \& 2-10 years (400 NmCV-5 recipients \& 200 Menactra recipients in each age strata). Each subject will receive a single dose of study vaccine and will be followed up for 6 months post vaccination during which solicited reactions (for seven days), unsolicited AEs (28 days) and SAEs (until the end of study i.e. 168 days after vaccination) will be collected. A blood sample will be collected at baseline (pre-vaccination) and at day 28 post-vaccination for immunogenicity assessment by a Serum Bactericidal Activity assay using rabbit complement (rSBA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,800
Polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to C reactive material (CRM) protein. The diluent is Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
Menactra is available as ready to use solution containing polysaccharide antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine
Centre pour le Développement des Vaccins du Mali, ex-Institut Marchoux, Ministry of Health, BP251
Bamako, Mali
Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine
Fajara, The Gambia
Seroresponse
Percentage of subjects with seroresponse, measured by rabbit complement serum bactericidal activity (rSBA) against serogroups A, C, Y, W and X. \[Seroresponse is defined as a post-immunization (Day 29) rSBA titer of 32 or greater if the subject's pre-immunization (Day 1) rSBA titer was \< 8; or a ≥ four-fold increase over baseline at Day 29 post-immunization if the subject's pre-immunization (Day 1) rSBA titer was ≥ 8\].
Time frame: 28 Days post vaccination
Geometric mean titres
Geometric mean titers (GMTs) measured by rSBA against serogroups A, C, Y, W and X on Day 29
Time frame: 28 Days post vaccination
Solicited adverse events
Solicited AEs for 7 days following vaccination
Time frame: 7 days post vaccination
Unsolicited adverse events
Unsolicited AEs for 28 days following vaccination
Time frame: 28 days post vaccination
Serious adverse events (SAEs)
SAEs for 6 months following vaccination
Time frame: 6 months post vaccination
Seroprotective rSBA titres
Percentage of subjects with rSBA titer of ≥ 8 against serogroups A, C, Y, W, and X at Day 1 and Day 29
Time frame: 28 days post vaccination
Long term protective rSBA titres
Percentage of subjects with rSBA titer of ≥ 128 against serogroups A, C, Y, W, and X at Day 1 and Day 29
Time frame: 28 days post vaccination
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