At a glance
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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 (13vpnc) When Administered Concomitantly With Trivalent Inactivated Influenza Vaccine In Healthy Adults 50-59 Years Of Age Who Are Naive To 23-valent Pneumococcal Polysaccharide Vaccine And To Evaluate The Immune Response Of A Second Dose Of 13vpnc Administered 5 Years After Initial 13vpnc Vaccination
In Brief
A Phase 3 clinical trial evaluating 13 valent pneumococcal conjugate vaccine for Influenza. Completed, enrolled 1,116 participants across 41 sites.
Detailed Summary
This study is to evaluate the safety, tolerability and immune response when 13-valent pneumococcal conjugate vaccine (13vPnC) and the trivalent inactivated flu vaccine (TIV) are given together to healthy adults aged 50-59 years who are naive to 23-valent pneumococcal polysaccharide vaccine (23vPS), or when the vaccines are given 1 month apart. It will also evaluate the immune response to 13vPnC once per year for 4 years and then to a second dose of 13vPnC given 5 years after the first dose.
Study Details
Timeline
Interventions
TIV +13vPnC at dose 1 placebo at dose 2, one month after dose 1 13vPnC at year 5
TIV + placebo at dose 1 13vPnC at dose 2, one month after dose 1 and 13vPnC at year 5