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A Phase 3, Randomized, Double-blind Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine When Administered Concomitantly With Trivalent Inactiva...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-002326-29

A Phase 3, Randomized, Double-blind Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine When Administered Concomitantly With Trivalent Inactivated Influenza Vaccine in Healthy Adults 65 Years of Age or Older Who Are Naive to 23-Valent Pneumococcal Polysaccharide Vaccine

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Extrait

[1] To demonstrate that the immune responses induced by TIV when administered concomitantly with 13vPnC are noninferior to the immune responses induced by TIV alone [2] To demonstrate that the immune responses to the 13vPnC serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) induced by 13vPnC when administered concomitantly with TIV are noninferior to the immune responses induced by 13vPnC administered 1 month after TIV [3] To evaluate the acceptability of the safety profile of 13vPnC+TIV given concomitantly and 13vPnC given alone

Critère d'inclusion

  • Pneumococcal infection

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