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

Merck Sharp & Dohme LLC58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Pneumococcal Disease

Interventions

V114BIOLOGICAL

15-valent pneumococcal conjugate vaccine (PCV) containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in Prevnar 13™ plus 2 additional serotypes (22F, 33F) in each 0.5 mL sterile suspension for intramuscular injection.

Eligibility

Sex: ALLMin age: 42 DaysMax age: 90 DaysHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (19)

Jeonbuk National University Hospital ( Site 0008)

Jeonju, Jeonrabugdo, South Korea

Outcomes

Primary Outcomes

Percentage of Participants With ≥1 Solicited Injection-site Adverse Events

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the doses of V114, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs consist of erythema, induration, pain, and swelling.

Time frame: Up to 7 days after any vaccination, up to a total of ~ 13 months

Percentage of Participants With ≥1 Solicited Systemic Adverse Events

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the doses of V114, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs consist of decreased appetite, irritability, somnolence, and urticaria.

Time frame: Up to 7 days after any vaccination, up to a total of ~ 13 months

Percentage of Participants With ≥1 Vaccine-related Serious Adverse Events

A serious adverse event (SAE) is an AE that 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. The percentage of participants with a vaccine-related SAE following any dose of V114 was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 through completion of study.

Time frame: Up to approximately 14.5 months

Percentage of Participants Discontinuing Study Therapy Due to an Adverse Event

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who discontinued study treatment due to an AE is reported.

Data from ClinicalTrials.gov

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