This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.
Participants will be randomized to 1 of 3 cohorts depending upon prior vaccinations. Prior vaccinations by cohort include: PPSV23 (pneumococcal vaccine, polyvalent \[23-valent\], PNEUMOVAX™23) for Cohort 1; PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) for Cohort 2; PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™), PCV20 (pneumococcal 20-valent conjugate vaccine; PREVNAR 20™), PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 for Cohort 3.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
717
Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, and 4 μg of 6B in each 0.5 mL sterile suspension
Pneumococcal 23-valent vaccine with 25 μg of each of the 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 in each 0.5 mL sterile solution
Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any injection with either V116, PCV15, or PPSV23 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were erythema, pain, and swelling.
Time frame: Up to 5 days post-vaccination
Percentage of Participants With Solicited Systemic AEs
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any of the injections with either V116, PCV15, or PPSV23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia.
Time frame: Up to 5 days post-vaccination
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, 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. The percentage of participants with one or more SAE that were assessed by the investigator to be at least possibly related to the study vaccination are presented.
Time frame: Up to ~180 days
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
OPA for the serotypes contained in V116 were determined using a multiplex opsonophagocytic assay (MOPA). GMT is defined as geometric mean titer (1/dil). Serotype-specific OPA GMTs with 95% confidence intervals are presented.
Time frame: 30 Days post-vaccination
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Central Research Associates ( Site 0024)
Birmingham, Alabama, United States
Lenzmeier Family Medicine/CCT Research ( Site 0008)
Glendale, Arizona, United States
Fiel Family and Sports Medicine, PC/CCT Research ( Site 0006)
Tempe, Arizona, United States
Southland Clinical Research Center ( Site 0026)
Fountain Valley, California, United States
Diablo Clinical Research, Inc. ( Site 0019)
Walnut Creek, California, United States
Alliance for Multispecialty Research, LLC ( Site 0020)
Coral Gables, Florida, United States
Indago Research & Health Center, Inc ( Site 0005)
Hialeah, Florida, United States
Advanced Medical Research Institute ( Site 0018)
Miami, Florida, United States
Solaris Clinical Research ( Site 0025)
Meridian, Idaho, United States
Centennial Medical Group ( Site 0002)
Elkridge, Maryland, United States
...and 41 more locations
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in V116 was determined using a pneumococcal electrochemiluminescence (PnECL) assay. Serotype-specific pneumococcal IgG GMCs with 95% confidence intervals are presented.
Time frame: 30 Days post-vaccination
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Activity for the serotypes contained in V116 was determined using a multiplex opsonophagocytic assay (MOPA). Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. The GMFRs in OPA responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented.
Time frame: Day 1 (Baseline) and 30 days post-vaccination
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Activity for the serotypes contained in V116 was determined using a MOPA. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for OPA responses with 95% confidence intervals are presented.
Time frame: Day 1 (Baseline) and 30 days post-vaccination
Geometric Mean Fold Rise of Serotype-specific IgG
Activity for the serotypes contained in V116 was determined using a PnECL assay. Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. The GMFRs IgG responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented.
Time frame: Day 1 (Baseline) and 30 days post-vaccination
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Activity for the serotypes contained in V116 was determined using a PnECL assay. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for IgG responses with 95% confidence intervals are presented.
Time frame: Day 1 (Baseline) and 30 days post-vaccination