This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-naïve Japanese adults 65 years of age and older. The polyvalent (23-valent) pneumococcal vaccine, PPSV23, is the active comparator. In addition to studying safety/tolerability, it is hypothesized that, at 30 days postvaccination, the immunogenicity of V116 is noninferior to PPSV23 for the 12 common serotypes in V116 and PPSV23 and the cross-reactive serotype 15B in V116, and that the immunogenicity of V116 is superior to PPSV23 for the unique serotype 15C in V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of participants with ≥4-fold rise from baseline in the 8 unique V116 serotypes (except for 15C), as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
450
Sterile 0.5 mL solution in prefilled syringe containing 4 μg of each pneumococcal polysaccharide (PnPs) antigen 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B.
Sterile 0.5 mL solution in prefilled syringe containing 25 μg of each PnPs antigen 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F.
Medical Corporation Heishinkai OPHAC Hospital ( Site 1008)
Osaka, Osaka, Japan
Medical Corporation Heishinkai OCROM Clinic ( Site 1003)
Suita-shi, Osaka, Japan
P-One Clinic ( Site 1001)
Hachiōji, Tokyo, Japan
Heishinkai Medical Group ToCROM Clinic ( Site 1004)
Shinjuku-ku, Tokyo, Japan
Medical Corporation Shinanokai Shinanozaka Clinic ( Site 1006)
Shinjuku-ku, Tokyo, Japan
Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 1005)
Toshima City, Tokyo, Japan
PS Clinic ( Site 1002)
Fukuoka, Japan
Nishikumamoto Hospital ( Site 1007)
Kumamoto, Japan
Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain.
Time frame: Up to 5 days postvaccination
Percentage of Participants With Solicited Systemic AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The solicited systemic AEs were muscle pain/myalgia, headache, and tiredness/fatigue.
Time frame: Up to 5 days postvaccination
Percentage of Participants With Vaccine-related Serious AEs (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were summarized.
Time frame: Up to 30 days postvaccination
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)
The serotype-specific OPA GMTs for the 12 common serotypes contained in V116 and PPSV23, the unique serotype 15C in V116, and the cross-reactive serotype 15B were determined using the multiplex opsonophagocytic assay (MOPA).
Time frame: Day 30 postvaccination
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs (Unique to V116)
The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs for the 8 unique serotypes contained in V116 (except for 15C) were determined.
Time frame: Baseline (Day 1) and Day 30 postvaccination
Serotype-specific OPA GMTs (Unique Serotypes)
The serotype-specific OPA GMTs for the 8 unique serotypes contained in V116 (except for serotype 15C) and the cross-reactive serotype 6C in V116 were determined using MOPA.
Time frame: Day 30 postvaccination
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
The GMCs for serotype-specific IgG antibodies were determined using pneumococcal electrochemiluminescence (PnECL).
Time frame: Day 30 postvaccination
Serotype-specific Geometric Mean Fold Rise (GMFR) in OPA GMT
The GMFR from baseline in serotype-specific OPA GMTs was determined using MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.
Time frame: Baseline (Day 1) and Day 30 postvaccination
Serotype-specific GMFR in IgG GMCs
The GMFR from baseline in GMCs for serotype-specific IgG antibodies was determined using PnECL. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.
Time frame: Baseline (Day 1) and Day 30 postvaccination
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPA GMTs (All Serotypes)
Activity for the serotypes contained in V116 and PPSV23 were determined using MOPA. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Time frame: Baseline (Day 1) and Day 30 postvaccination
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs (All Serotypes)
Activity for the serotypes contained in V116 and PPSV23 were determined using PnECL. The percentage of participants who had ≥4-fold rise in IgG titers were calculated from baseline to postvaccination.
Time frame: Baseline (Day 1) and Day 30 postvaccination
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