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A Phase III Double-Blind, Randomized Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of ZOSTAVAX administered comcomitantly versus Non-concomitantly with PNEUMOVAX 23 in subj...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-000344-26

A Phase III Double-Blind, Randomized Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of ZOSTAVAX administered comcomitantly versus Non-concomitantly with PNEUMOVAX 23 in subjects 60 years of age and older

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Extrait

1. To determine whether ZOSTAVAX™ administered concomitantly with PNEUMOVAX™ 23 elicits a VZV antibody response that is noninferior to that of ZOSTAVAX™ administered nonconcomitantly. 2. To demonstrate whether ZOSTAVAX™ elicits an acceptable VZV antibody response when administered concomitantly with PNEUMOVAX™ 23. 3. To assess whether PNEUMOVAX™ 23 administered concomitantly with ZOSTAVAX™ elicits serotype-specific pneumococcal antibody responses for serotypes 3, 14, 19A, and 22F that are noninferior to those of PNEUMOVAX™ 23 administered nonconcomitantly

Critère d'inclusion

  • herpes zoster, pneumococcal infection

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