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A Phase 3, Randomized, Active-Controlled, Modified Double-Blind Trial, Evaluating the Safety, Tolerability, and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine Compared With a 23-Valent P...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-004465-18

A Phase 3, Randomized, Active-Controlled, Modified Double-Blind Trial, Evaluating the Safety, Tolerability, and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine Compared With a 23-Valent Pneumococcal Polysaccharide Vaccine (23vPS) in Ambulatory Elderly Individuals Aged 70 Years and Older Who Received 1 Dose of 23vPS at Least 5 Years Before Study Enrollment

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Extrait

[1] To demonstrate that 13vPnC is as immunogenic as 23vPS for the 12 common serotypes contained in 13vPnC as measured by serotype-specific opsonophagocytic assay (OPA) titers 1 month after initial study vaccination (year 0). [2] To show that the proportion of subjects receiving 13vPnC and exhibiting a 4-fold rise in the 6A OPA titer is statistically significantly greater than the proportion of subjects receiving 23vPS exhibiting the same 4-fold rise, measured 1 month after initial study vaccination (year 0).

Critère d'inclusion

  • Pneumococcal infection

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