At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Active-controlled, Modified Double-blind Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-valent Pneumococcal Conjugate Vaccine (13vpnc) Compared To A 23-valent Pneumococcal Polysaccharide Vaccine (23vps) In Adults 60 To 64 Years Old Who Are Naive To 23vps And The Safety, Tolerability, And Immunogenicity Of 13vpnc In Adults 18-59 Years Old Who Are Naïve To 23vps
In Brief
A Phase 3 clinical trial evaluating 13-valent pneumococcal conjugate vaccine (13vPnC) and 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) for Pneumococcal Infections. Completed, enrolled 2,141 participants across 26 sites.
Detailed Summary
This study will assess the safety, tolerability and immune response of 13-valent pneumococcal conjugate vaccine (13vPnC) compared with 23-valent Pneumococcal Polysaccharide Vaccine (23vPS). Although the study started with only 1 population, amendments to the original protocol will now reflect three participant populations. Three age cohorts will be enrolled. The first cohort (age 60-64) will be blinded. Cohort 2 (age 50-59) and cohort 3 (age 18-49) are open label. Subjects in cohorts 1 and 2 will receive 2 vaccinations 3-4 years apart. Subjects in cohort 3 will receive 1 vaccination. All participants should be naïve of 23vPS. Comparisons of immune responses from the different cohorts will be done.
Study Details
Timeline
Interventions
0.5 mL dose administered on day 1
0.5 mL dose administered on day 1
0.5 mL dose administered on day 1
0.5 mL dose administered on day 1
0.5 mL dose administered 3-4 years after dose 1
0.5 mL dose administered 3-4 years after dose 1
0.5 mL dose administered 3-4 years after dose 1