Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine (V116) in Japanese Adults (V116-002)

Study Overview
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Brief Summary
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The 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.

Official Title
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A Phase 1, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults.

Conditions
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Pneumococcal Infection

Intervention / Treatment
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* Biological: V116
* Biological: PNEUMOVAX™23


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: is a healthy Japanese male or female ≥20 years of age at time of randomization male participants must agree to be abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention female participants must not be pregnant or breastfeeding, and is either: not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to remain abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention Exclusion Criteria: has a history of invasive pneumococcal disease (IPD) within 3 years of Day 1 has a known hypersensitivity to any vaccine components has impaired immunological function has a coagulation disorder had a recent febrile illness (axillary temperature ≥37.5°C or equivalent) within 72 hours before Day 1 has a known malignancy that is progressing/requiring treatment has received, or is expected to receive, a pneumococcal vaccine outside the study protocol has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed the regimen for ≥30 days prior to Day 1 is receiving immunosuppressive therapy has received any non-live vaccine from 14 days prior to Day 1 other than inactivated influenza vaccine has received any live vaccine from 30 days prior to Day 1 has received a blood transfusion or blood products has participated in another clinical trial within 2 months of this study has clinically relevant drug or alcohol abuse has any condition that, in the opinion of the investigator, precludes participation in this study

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V116<br>Participants receive a single 1.0 mL intramuscular (IM) injection of V116 on Day 1. | Biological: V116<br>* Pneumococcal 21-valent conjugate vaccine with 2 μg of each of the following 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<br>* Other names: Pneumococcal 21-valent Conjugate Vaccine;|
| Active Comparator: PNEUMOVAX™23<br>Participants receive a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1. | Biological: PNEUMOVAX™23<br>* Pneumococcal 23-valent polyvalent vaccine with 25 μg of each of the following 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<br>* Other names: PPSV23;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | 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. Solicited injection-site AEs included tenderness/pain, redness/erythema, and swelling. The percentage of participants with one or more solicited injection-site AE was reported for each arm. | Up to 5 days postvaccination | 
| Percentage of Participants With a Solicited Systemic AE | 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. Solicited systemic AEs included headache, muscle pain/myalgia, joint pain/arthralgia, and tiredness/fatigue. The percentage of participants with one or more solicited systemic AE was reported for each arm. | Up to 5 days postvaccination | 
| Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) | An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were reported. | Up to 62 days postvaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 | The serotype-specific OPA GMTs for serotypes common to V116 and PNEUMOVAX™23 were determined using the multiplex opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group measures of dispersion (MOD) were not calculated. | Day 30 postvaccination | 
| Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 | The GMCs for serotype-specific pneumococcal IgG antibodies were measured using pneumococcal electrochemiluminescence (PnECL). Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated. | Day 30 postvaccination | 
| Serotype-specific OPA GMTs for the Unique Serotypes in V116 | The serotype-specific OPA GMTs for serotypes unique to V116 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated. | Day 30 postvaccination | 
| Serotype-specific IgG GMCs for the Unique Serotypes in V116 | The GMCs for serotype-specific pneumococcal IgG antibodies unique to V116 were measured using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated. | Day 30 postvaccination | 
| Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA | GMTs for the serotypes in V116 and PNEUMOVAX™23 were determined using the MOPA at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMT/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal serotype was calculated. | Baseline (Day 1) and Day 30 postvaccination | 
| GMFR From Baseline in Serotype-specific IgG GMCs | GMCs for the serotypes in V116 and PNEUMOVAX™23 were measured by PnECL at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMC/Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal serotype was calculated. | Baseline (Day 1) and Day 30 postvaccination |