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What were the results from the pivotal clinical trial?

April 26, 2017clinical trial Pivotal results

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What were the results from the pivotal clinical trial?

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Among adolescents (aged 11 to 18 years) enrolled in the pivotal trial, Menveo demonstrated noninferiority to Menactra for all 4 serogroups using the primary endpoint (hSBA seroresponse). The percentage of subjects with hSBA seroresponse was statistically higher for serogroups A, W-135, and Y in the Menveo group, as compared to the Menactra group.1 The clinical relevance of higher postvaccination immune responses is not known. Among adults (aged 19 to 55 years) enrolled in the pivotal trial, Menveo demonstrated noninferiority to Menactra for all 4 serogroups using the primary endpoint (hSBA seroresponse). The percentage of subjects with hSBA seroresponse was statistically higher for serogroups C, W-135, and Y in the Menveo group, as compared to the Menactra group.1 The clinical relevance of higher postvaccination immune responses is not known.