Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-DT): A Multicenter, Open-label, Non-randomized, Phase III Clinical Trial.
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Date
2014-06
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Abstract
Objective: To assess the safety and immunogenicity of a
quadrivalent meningococcal (groups A,C,Y,W) polysaccharide
diphtheria toxoid conjugate vaccine (MenACYW-DT) in India.
Design: Open-label, descriptive, non-randomized study.
Setting: Three medical college hospitals, one each in New Delhi,
Bengaluru and Mumbai, India.
Participants: 300 healthy, vaccine-naïve participants (100
children aged 2-11 years, 100 adolescents aged 12-17 years, and
100 adults aged 18-55 years).
Intervention: One dose (0.5 mL) of MenACYW-DT administered
intramuscularly.
Main outcome measures: Serum bactericidal antibody titers
against A, C, Y, and W were measured before and after
MenACWY-DT vaccination. Safety data were also collected
Results: Thirty days post-vaccination, geometric mean titers rose
across all serogroups. Most participants had protective titers ≥8
(1/dil) across the four serogroups. The percentage (95% CI)
achieving ≥8 (1/dil) in the Adolescent Group was typical – A:
96.9% (91.2%; 99.4%); C: 96.9% (91.2%; 99.4%); Y:100%
(96.3%; 100%); W:100% (96.3%; 100%). In general, solicited
reactions were mild and short-lived. Unsolicited events were
uncommon and unrelated to vaccination.
Conclusions: MenACYW-DT was well tolerated and elicited a
robust and protective immune response 30 days post-vaccination
against meningococcal serogroups A, C, Y, and W-135 in the
Indian study participants aged 2-55 years.
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Keywords
Efficacy, Immunization, Neisseria meningitidis, Protection, Vaccine
Citation
Yadav Sangeeta, Manglani M V, Narayan D H Ashwath, Sharma S, Ravish H S, Arora R, Castells V Bosch, Arya S, Oster P. Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-DT): A Multicenter, Open-label, Non-randomized, Phase III Clinical Trial. Indian Pediatrics. 2014 June; 51(6): 451-456.