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.
Overview
- Phase
- Phase 3
- Intervention
- V114
- Conditions
- Pneumococcal Disease
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 58
- Locations
- 19
- Primary Endpoint
- Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G ≥0.35 µg/mL
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
V114
Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age.
Intervention: V114
Outcomes
Primary Outcomes
Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G ≥0.35 µg/mL
Time Frame: 30 days after vaccination 3 (Up to a total of ~5 months)
The percentage of participants with immunoglobulin G (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) at 30 days postdose 3 is reported. The multiplex, pneumococcal electrochemiluminescence (PnECL) v2.0 assay was used to quantify IgG serotype-specific antibodies.
Percentage of Participants With ≥1 Solicited Systemic Adverse Events
Time Frame: Up to 7 days after any vaccination, up to a total of ~ 13 months
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.
Percentage of Participants With ≥1 Vaccine-related Serious Adverse Events
Time Frame: Up to approximately 14.5 months
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.
Percentage of Participants Discontinuing Study Therapy Due to an Adverse Event
Time Frame: Up to approximately 13 months
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.
Percentage of Participants With ≥1 Solicited Injection-site Adverse Events
Time Frame: Up to 7 days after any vaccination, up to a total of ~ 13 months
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.
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 3
Time Frame: 30 days after vaccination 3 (Up to a total of ~5 months)
The anti-pneumococcal polysaccharides (PnPs) serotype-specific IgG geometric mean concentrations (GMCs) at 30 days postdose 3 for each serotype-specific were reported. The multiplex, electrochemiluminescence (ECL)-based PnECL v2.0 assay was used to quantify IgG serotype-specific antibodies.
Secondary Outcomes
- Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 4(30 days after vaccination 4 (Up to a total of ~14 months))