Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine (V116) in...
Pneumococcal InfectionThe purpose of this study is to compare the safety, tolerability, and immunogenicity of a polyvalent pneumococcal conjugate vaccine (V116) with that of PNEUMOVAX™23 in healthy Japanese adults.
Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults
Pneumococcal DiseaseThe safety and immunogenicity of EuPCV15 compared to Prevenar13 are assessed in healthy adults.
Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE)
Pneumococcal InfectionsThe purpose of this study is to 1) evaluate the safety and tolerability of V114 and 2) to compare the immune responses of the 15 serotypes contained in V114 with V114 versus Prevnar 13™. The primary hypotheses are that 1) V114 is noninferior to Prevnar 13™ as measured by the serotype specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for 13 shared serotypes at 30 days postvaccination and that 2) V114 is superior to Prevnar 13™ as measured by serotype-specific OPA GMTs for 2 unique serotypes in V114 at 30 days postvaccination.
Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-028)
Pneumococcal InfectionsThe purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 administered subcutaneously or intramuscularly in healthy Japanese infants (3 months of age).
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic...
Pneumococcal InfectionsThe purpose of this study is to 1) evaluate the safety and tolerability, and immunogenicity of blinded V114 and Prevnar 13™ within each vaccination group, and 2) evaluate the safety and tolerability, and immunogenicity of PNEUMOVAX™23 (administered as open label, 12 months after allogeneic hematopoietic stem cell transplant [allo-HSCT] in participants who do not develop chronic graft-versus-host disease [GVHD]).
Immunogenicity and Safety of a Tetanus-diphtheria Vaccine and a 13-valent Pneumococcal Conjugate...
TetanusDiphtheria1 moreWhen two or more vaccines are administered concurrently, there is a concern on vaccine interaction, which can either enhance or suppress immune response to vaccine antigens. This study is designed to evaluate the immunogenicity and safety of tetanus-diphtheria (Td) and pneumococcal vaccines after concomitant administration in adults aged 50 years and older.
Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine...
Pneumococcal DiseaseThis is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18 through 49 years of age with no history of pneumococcal vaccination will be randomized in a 2:2:2:1 ratio to receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or 13vPnC.
A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults...
Pneumococcal DiseaseThis study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of age. The primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days postvaccination for all serotypes included in V116.
Lot-to-lot Consistency of 23-valent Pneumococcal Polysaccharide Vaccine
Pneumococcal InfectionsThis study is a randomized, double-blind phase Ⅳ clinical trial of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the consistency of three consecutive lots, immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine of commercial scale in participants aged 40-65 years.
Safety and Immunogenicity of V116 in Vaccine-naïve Japanese Older Adults (V116-009, STRIDE-9)
Pneumococcal DiseaseThis 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).