A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Reactogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Ambulatory Elderly Adults Aged 68 Years and Older Who R...

Update Il y a 4 ans
Reference: EUCTR2007-002683-10

A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Reactogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Ambulatory Elderly Adults Aged 68 Years and Older Who Received 1 or More Doses of 23-valent Pneumococcal Polysaccharide Vaccine at Least 3 Years Before Study Enrollment

Woman and Man

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Extract

To evaluate the acceptability of the safety profile of a single injection of 13vPnC administered at least 3 years after 1 or more nonstudy doses of 23vPS as measured by the incidence rates of local reactions, systemic events, and adverse events.


Inclusion criteria

  • Pneumococcal infection