This study will evaluate the safety, tolerability and immunogenicity of study vaccines 13vPnC and 23vPS in older, healthy subjects who have previously received a dose of 23vPS at least 5 years ago. It will also evaluate the safety, tolerability and immunogenicity to a dose of 13vPnC 1 year after the initial dose of study vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
938
0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1
0.5-mL dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 1
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0)
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Time frame: 1 month after Vax 1 / Year 0
Percentage of Participants Achieving a ≥ 4-fold Rise for Serotype 6A OPA Titer for 13vPnC Relative to 23vPS (Vax 1 / Year 0)
OPA titer for the 6A serotype measured for at least a 4-fold increase from the prevaccination to postvaccination blood sample collection. Exact 2-sided CI (Clopper and Pearson) based upon the observed percentage of participants.
Time frame: Baseline, 1 month after Vax 1 / Year 0
Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC Relative to 23vPS (Vax 1 / Year 0)
Antibody geometric mean titer as measured by OPA assay for the 6A pneumococcal serotype. Confidence intervals for the GMT are back transformation of a CI based on the Student t distribution for the mean logarithm of the titer.
Time frame: 1 month after Vax 1 / Year 0
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)
Antibody geometric mean titers as measured by OPA assays for the 13 serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Time frame: 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)
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Pfizer Investigational Site
Mobile, Alabama, United States
Pfizer Investigational Site
Mesa, Arizona, United States
Pfizer Investigational Site
Mesa, Arizona, United States
Pfizer Investigational Site
Fountain Valley, California, United States
Pfizer Investigational Site
Denver, Colorado, United States
Pfizer Investigational Site
Waterbury, Connecticut, United States
Pfizer Investigational Site
Clearwater, Florida, United States
Pfizer Investigational Site
Coral Gables, Florida, United States
Pfizer Investigational Site
Jacksonville, Florida, United States
Pfizer Investigational Site
Pinellas Park, Florida, United States
...and 48 more locations
Antibody geometric mean titers as measured by OPA assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Time frame: 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1
Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)
Antibody geometric mean titer as measured by OPA assay for the 6A serotype. Confidence intervals (CI) for the GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titer.
Time frame: 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1