A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children 2 through 17 years of age. Researchers want to learn if V116 is as good as, or is better than the PPSV23 vaccine in terms of the antibody immune response. V116 and PPSV23 will be studied in children and teenagers who have a higher risk of getting invasive pneumococcal disease (IPD).

Official Title
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A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Children and Adolescents With Increased Risk of Pneumococcal Disease

Conditions
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Pneumococcal Infection

Intervention / Treatment
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* Biological: V116
* Biological: PPSV23


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has a diagnosis and stable medical management (for at least 3 months) of one of the following risk conditions for pneumococcal disease: Diabetes mellitus, chronic compensated liver disease, chronic lung disease, chronic heart disease, or chronic kidney disease. Has completed pneumococcal conjugate vaccine regimen (PCV7, PCV10, or PCV13) at least 8 weeks before study enrollment. Exclusion Criteria: Has previously received PPSV23 vaccine Has a history of active hepatitis within 3 months before study vaccination History of invasive pneumococcal disease within 3 years before study vaccination

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V116<br>Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1 | Biological: V116<br>* Pneumococcal 21-valent conjugate vaccine with 4 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: PPSV23<br>Participants will receive a single 0.5 mL IM dose of PPSV23 on Day 1. | Biological: PPSV23<br>* Pneumococcal 23-valent conjugate 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: PNEUMOVAX™23;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. Solicited injection-site AEs include pain/tenderness, redness/erythema, and swelling. | Up to 5 days | 
| 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. Solicited systemic AEs include headache, muscle aches/myalgia, and tiredness/fatigue. | Up to 5 days | 
| Percentage of participants with vaccine-related serious adverse events (SAEs) | A vaccine-related 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. | Up to approximately 6 months | 
| Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses | Opsonophagocytic activity (OPA) for the serotypes in V116 will be determined using a multiplexed opsonophagocytic assay (MOPA) | 30 days postvaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean concentrations (GMCs) of serotype-specific Immunoglobulin G (IgG) after vaccination | The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (PnECL) | 30 days postvaccination | 
| Geometric mean fold rise (GMFR) from baseline in serotype-specific OPA GMTs | The GMFR from baseline in serotype-specific OPA GMTs will be determined using MOPA. | Baseline (Day 1) and Day 30 postvaccination | 
| Percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs GMTs | The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPA GMTs will be determined with MOPA. | Baseline (Day 1) and Day 30 postvaccination | 
| GMFR from baseline in serotype-specific IgG GMCs | The GMFR from baseline in GMCs for serotype-specific IgG antibodies will be determined using PnECL. | Baseline (Day 1) and Day 30 postvaccination | 
| Percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs | The percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs will be determined using PnECL. | Baseline (Day 1) and Day 30 postvaccination |