Safety and Immunogenicity of V114 in Healthy Infants in South Korea (V114-036)

Study Overview
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Brief Summary
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The primary purpose of this phase 3, single-arm, open-label study is to evaluate the safety and immunogenicity of a 4-dose regimen of V114 administered to healthy infants in South Korea.

Official Title
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A Phase 3, Single-Arm, Open-label Clinical Study to Evaluate the Safety and Immunogenicity of 4 Doses of V114 Administered to Healthy Infants in South Korea.

Conditions
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Pneumococcal Disease

Intervention / Treatment
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* Biological: V114


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: is a healthy South Korean male or female who is 42 to 90 days of age at the time of signing informed consent has a parent or legally acceptable representative who understands study procedures, alternative treatments available, and risks involved and voluntarily agrees to participate by signing informed consent Exclusion Criteria: has a history of invasive pneumococcal disease or known history of other culture positive pneumococcal disease has known hypersensitivity to pneumococcal conjugate vaccine, any licensed pediatric vaccine to be administered concomitantly, or any diphtheria toxoid-containing vaccine has had a recent febrile illness (rectal temperature ≥38.1°C [≥100.5°F] or axillary temperature ≥37.8°C [≥100.0°F]) within 72 hours prior to receipt of study vaccine has known or suspected impairment of immunological function has or his/her mother has human immunodeficiency virus (HIV) infection has or his/her mother has hepatitis B surface antigen-positive test has known or history of functional or anatomic asplenia has a history of autoimmune disease has a history or suspected history of neurological disorder has received a pneumococcal vaccine prior to study entry has received, or is anticipated to need, corticosteroid therapy has received a blood transfusion of immunoglobulin products has participated in another clinical study of an investigational product

Ages Eligible for Study
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Minimum Age: 42 Days
Maximum Age: 90 Days

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V114<br>Participants receive 4 total doses of V114, administered at  2, 4, 6, and 12-15 months of age. | Biological: V114<br>* V114 0.5 mL sterile suspension for intramuscular injection.<br>* Other names: Pneumococcal 15-Valent Conjugate Vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with ≥1 solicited injection-site adverse events (AEs) | Solicited injection-site AEs consist of swelling, redness, pain or tenderness, and hard lump. | Up to 7 days after any vaccination | 
| Percentage of participants with ≥1 solicited systemic AEs | Solicited systemic AEs consist of irritability, drowsiness, loss of appetite, and hives or welts. | Up to 7 days after any vaccination | 
| Percentage of participants with ≥1 vaccine-related serious adverse events (SAEs) | An SAE is an untoward medical occurrence in a clinical study participant that results in death, is life-threatening, requires/prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital birth defect, or other important medical event. | Up to approximately 14.5 months | 
| Percentage of participants discontinuing study therapy due to AE(s) | An AE is an 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. | Up to 13 months | 
| Percentage of participants with anti-pneumococcal polysaccharides (PnPs) serotype-specific immunoglobulin G (IgG) ≥0.35 µg/mL | The percentage of participants with IgG threshold values of ≥0.35 µg/mL for the 15 serotypes contained in V114 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) will be reported. The multiplex, electrochemiluminescence (ECL)-based PnECL v2.0 assay will be used to quantify IgG serotype-specific antibodies. | 30 days after vaccination 3 | 
| Geometric mean concentrations (GMCs) of anti-PnPs serotype-specific IgG | The GMCs of each serotype-specific IgG will be reported. | 30 days after vaccination 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean concentrations (GMCs) of anti-PnPs serotype-specific IgG | The GMCs of each serotype-specific IgG will be reported. | 30 days after vaccination 4 |