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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Disease

Treatments: Biological: V114

Study type: Interventional

Funder types: Industry

Identifiers

NCT04633226

2020-003181-39 (EudraCT Number)

V114-036 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 42 to 90 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

V114

Experimental group

Description:

Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age.

Treatment:

Biological: V114