Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-DT): A Multicenter, Open-label, Non-randomized, Phase III Clinical Trial.
| dc.contributor.author | Yadav, Sangeeta | |
| dc.contributor.author | Manglani, M V | |
| dc.contributor.author | Narayan, D H Ashwath | |
| dc.contributor.author | Sharma, S | |
| dc.contributor.author | Ravish, H S | |
| dc.contributor.author | Arora, R | |
| dc.contributor.author | Castells, V Bosch | |
| dc.contributor.author | Arya, S | |
| dc.contributor.author | Oster, P | |
| dc.date.accessioned | 2016-01-20T05:13:44Z | |
| dc.date.available | 2016-01-20T05:13:44Z | |
| dc.date.issued | 2014-06 | |
| dc.description.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. | en_US |
| dc.identifier.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. | en_US |
| dc.identifier.uri | https://imsear.searo.who.int/handle/123456789/170642 | |
| dc.language.iso | en | en_US |
| dc.source.uri | https://www.indianpediatrics.net/june2014/june-451-456.htm | en_US |
| dc.subject | Efficacy | en_US |
| dc.subject | Immunization | en_US |
| dc.subject | Neisseria meningitidis | en_US |
| dc.subject | Protection | en_US |
| dc.subject | Vaccine | en_US |
| dc.title | Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-DT): A Multicenter, Open-label, Non-randomized, Phase III Clinical Trial. | en_US |
| dc.type | Article | en_US |