Out of the 13 identified serogroups of Neisseria meningitidis (Nm) the six serogroups (A, B, C, W, Y and X) are responsible for majority of infections. Presently available vaccines effectively protect against A, B, C, W and Y serogroups; but no vaccine that is protective against serogroup X is available yet. Serum Institute of India Private Limited (SIIPL) has developed a conjugate vaccine against serogroups A, C, Y, W and X (NmCV-5). The first-in-human Phase 1 study was among 60 healthy adults in USA did not show no any safety issues. This phase 2 study is designed to evaluate safety and immunogenicity of the non-adjuvanted and adjuvanted formulations of NmCV-5 in healthy children 12-16 months of age, in comparison with the licensed quadrivalent meningococcal conjugate vaccine (Menactra®). Both vaccines will be administered in two dose schedule 3 months apart. among vaccine-naïve healthy subjects in Mali. Safety will be assessed by collecting solicited reactions till day 7 post each dose whereas adverse events will be collected throughout the study. Each subject will be followed up for 84 days post each vaccine dose. The vaccine immunogenicity will measured using a rabbit complement serum bactericidal activity assay (rSBA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
375
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.
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
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.
Centre pour le Développement des Vaccins du Mali, ex-Institut Marchoux, Ministry of Health, BP251
Bamako, Mali
Severe Solicited Adverse Event
Number and Percentage of subjects with at least one severe solicited AE within 7 days after any study vaccination (Days 0-6 and Days 84-90)
Time frame: 7 days post each vaccination
Seroprotective rSBA Titres
Percentage of subjects with rSBA titer ≥ 8 against serogroups A, C, W, Y and X at Visits Day 0 (Baseline), Day 28 (28 days after dose 1), Day 84 (prior to dose 2) and Day 112 (28 days after dose 2)
Time frame: 112 days
Long Term Protective rSBA Titres
Percentage of subjects with rSBA titer ≥ 128 against serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112
Time frame: 112 days
Rise in rSBA Titres
Percentage of subjects with fourfold rise in rSBA titers against serogroups A, C, W, Y and X at Visits Day 28 and Day 112. * For subjects with a pre-vaccination rSBA titer \< 8, a post-vaccination titer of ≥ 32; * For subjects with a pre-vaccination rSBA titer ≥ 8, an increase in rSBA titer of at least 4 times the pre-vaccination titer
Time frame: 112 days
Geometric Mean of rSBA Titres
rSBA GMT for serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112
Time frame: 112 Days
Solicited Reactions
Solicited local and systemic AEs reported during the 7 days after each vaccination (Days 0-6 and Days 84-90);
Time frame: 7 days post each vaccination
Adverse Events
Unsolicited AEs reported during 28 days after each vaccination (Days 0-27 and Days 84-111);
Time frame: 112 Days
Other Adverse Events
AEs leading to premature withdrawal during the entire study period;
Time frame: 168 Days
Serious Adverse Events
SAEs reported during the entire study period
Time frame: 168 Days
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