PNEU-PED-KOR: Safety and Immunogenicity of V114 in Healthy Infants in South Korea (V114-036)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: V114 Participants receive 4 total doses of V114, administered at ~2, 4, 6, and 12-15 months of age. |
Biological: V114
V114 0.5 mL sterile suspension for intramuscular injection.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants with ≥1 solicited injection-site adverse events (AEs) [Up to 7 days after any vaccination]
Solicited injection-site AEs consist of swelling, redness, pain or tenderness, and hard lump.
- Percentage of participants with ≥1 solicited systemic AEs [Up to 7 days after any vaccination]
Solicited systemic AEs consist of irritability, drowsiness, loss of appetite, and hives or welts.
- Percentage of participants with ≥1 vaccine-related serious adverse events (SAEs) [Up to approximately 14.5 months]
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.
- Percentage of participants discontinuing study therapy due to AE(s) [Up to 13 months]
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.
- Percentage of participants with anti-pneumococcal polysaccharides (PnPs) serotype-specific immunoglobulin G (IgG) ≥0.35 µg/mL [30 days after vaccination 3]
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.
- Geometric mean concentrations (GMCs) of anti-PnPs serotype-specific IgG [30 days after vaccination 3]
The GMCs of each serotype-specific IgG will be reported.
Secondary Outcome Measures
- Geometric mean concentrations (GMCs) of anti-PnPs serotype-specific IgG [30 days after vaccination 4]
The GMCs of each serotype-specific IgG will be reported.
Eligibility Criteria
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
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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
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has known or suspected impairment of immunological function
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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
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has a history of autoimmune disease
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jeonbuk National University Hospital ( Site 0008) | Jeonju-si | Jeonrabugdo | Korea, Republic of | 54907 |
| 2 | Korea University Ansan Hospital ( Site 0006) | Ansan-si | Kyonggi-do | Korea, Republic of | 15355 |
| 3 | Hallym University Sacred Heart Hospital ( Site 0011) | Anyang-si | Kyonggi-do | Korea, Republic of | 14068 |
| 4 | Hallym University Dongtan Sacred Heart Hospital ( Site 0013) | Hwaseong-si | Kyonggi-do | Korea, Republic of | 18450 |
| 5 | CHA Bundang Medical Center CHA University ( Site 0020) | Seongnam si | Kyonggi-do | Korea, Republic of | 13496 |
| 6 | Changwon Fatima Hospital ( Site 0015) | Changwon | Kyongsangnam-do | Korea, Republic of | 51394 |
| 7 | Pusan National University Yangsan Hospital ( Site 0009) | Yangsan-si | Kyongsangnam-do | Korea, Republic of | 50612 |
| 8 | Kyungpook National University Hospital ( Site 0014) | Daegu | Taegu-Kwangyokshi | Korea, Republic of | 41944 |
| 9 | The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 0012) | Incheon | Korea, Republic of | 21431 | |
| 10 | Gachon University Gil Medical Center ( Site 0019) | Incheon | Korea, Republic of | 21565 | |
| 11 | Inha University Hospital ( Site 0001) | Incheon | Korea, Republic of | 22332 | |
| 12 | Korea Cancer Center Hospital ( Site 0017) | Seoul | Korea, Republic of | 01812 | |
| 13 | Nowon Eulji Medical Center, Eulji University ( Site 0005) | Seoul | Korea, Republic of | 01830 | |
| 14 | Severance Hospital Yonsei University Health System ( Site 0002) | Seoul | Korea, Republic of | 03722 | |
| 15 | Samsung Medical Center ( Site 0007) | Seoul | Korea, Republic of | 06351 | |
| 16 | The Catholic University of Korea ( Site 0003) | Seoul | Korea, Republic of | 06591 | |
| 17 | Chung-Ang University Hospital ( Site 0016) | Seoul | Korea, Republic of | 06973 | |
| 18 | Ewha Womans University Seoul Hospital ( Site 0010) | Seoul | Korea, Republic of | 07804 | |
| 19 | Korea University Guro Hospital ( Site 0021) | Seoul | Korea, Republic of | 08308 |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- V114-036
- V114-036
- 2020-003181-39