The purpose of this study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine compared to a single dose of 23-valent pneumococcal polysaccharide vaccine in Japanese adults aged 65 years old and older.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
764
A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
Medical Co.LTA PS Clinic
Fukuoka, Fukuoka, Japan
Seishinkai Inoue Hospital
Itoshima, Fukuoka, Japan
Yokohama Minoru Clinic
Yokohama, Kanagawa, Japan
Uzumasa Medical Clinic
Kyoto, Kyoto, Japan
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination
Antibody-mediated serum OPA against each of the 12 pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolony OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Time frame: One month after vaccination
Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 Month After Vaccination
For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
Time frame: One month after vaccination
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination
Antibody-mediated serum OPA against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolonoy OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Time frame: One month after vaccination
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Senbon Hospital
Osaka, Osaka, Japan
Oda Clinic
Shinjuku-ku, Tokyo, Japan
Sone Clinic
Shinjuku-ku, Tokyo, Japan
Medical Co. LTA Sumida Hospital
Sumida-ku, Tokyo, Japan