Safety and Immunogenicity of V114 in Healthy Infants in South Korea (V114-036)
- Registration Number
- NCT04633226
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description V114 V114 Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G ≥0.35 µg/mL 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 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 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 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 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 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 Outcome Measures
Name Time Method 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) The anti-PnPs serotype-specific IgG GMCs at 30 days postdose 4 for each serotype-specific were reported. The multiplex, ECL-based PnECL v2.0 assay was used.
Trial Locations
- Locations (19)
Jeonbuk National University Hospital ( Site 0008)
🇰🇷Jeonju-si, Jeonrabugdo, Korea, Republic of
Hallym University Dongtan Sacred Heart Hospital ( Site 0013)
🇰🇷Hwaseong-si, Kyonggi-do, Korea, Republic of
CHA Bundang Medical Center CHA University ( Site 0020)
🇰🇷Seongnam si, Kyonggi-do, Korea, Republic of
Korea University Ansan Hospital ( Site 0006)
🇰🇷Ansan-si, Kyonggi-do, Korea, Republic of
Hallym University Sacred Heart Hospital ( Site 0011)
🇰🇷Anyang-si, Kyonggi-do, Korea, Republic of
Gachon University Gil Medical Center ( Site 0019)
🇰🇷Incheon, Korea, Republic of
The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 0012)
🇰🇷Incheon, Korea, Republic of
Pusan National University Yangsan Hospital ( Site 0009)
🇰🇷Yangsan-si, Kyongsangnam-do, Korea, Republic of
Inha University Hospital ( Site 0001)
🇰🇷Incheon, Korea, Republic of
Kyungpook National University Hospital ( Site 0014)
🇰🇷Daegu, Taegu-Kwangyokshi, Korea, Republic of
Korea Cancer Center Hospital ( Site 0017)
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 0002)
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital ( Site 0016)
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center ( Site 0007)
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea ( Site 0003)
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Seoul Hospital ( Site 0010)
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital ( Site 0021)
🇰🇷Seoul, Korea, Republic of
Nowon Eulji Medical Center, Eulji University ( Site 0005)
🇰🇷Seoul, Korea, Republic of
Changwon Fatima Hospital ( Site 0015)
🇰🇷Changwon, Kyongsangnam-do, Korea, Republic of