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Clinical Trial Summary

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).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03295318
Study type Interventional
Source Serum Institute of India Pvt. Ltd.
Contact
Status Completed
Phase Phase 2
Start date November 15, 2017
Completion date August 31, 2018

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