At a glance
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A Phase 4, Open-label Trial Describing The Safety, Tolerability, And Immunogenicity Of The 13 Valent Pneumococcal Conjugate Vaccine In Preterm Compared To Term Infants
In Brief
A Phase 4 clinical trial evaluating 13-valent pneumococcal conjugate vaccine for 13-valent Pneumococcal Vaccine and 3 related conditions. Completed, enrolled 200 participants across 12 sites in 2 countries.
Detailed Summary
The purpose of this study is to describe the safety, tolerability, and immunogenicity of a 2,3,4 and 12 month schedule of the 13-valent pneumococcal conjugate vaccine when given to preterm infants with concomitant vaccines, compared to infants born at term.There will be a follow-up phase to assess the persistence of the antibody response at 24 and 36 months of age.
Study Details
Timeline
Interventions
13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.
13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.