Clinical trial NCT04633226: Safety and Immunogenicity of V114 in Healthy Infants in South Korea (V114-036)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2020-11-18
Enrollment: 58
Sex: ALL
Minimum age (years): 42
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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
* 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

Primary outcomes:
measure: Percentage of Participants With ≥1 Solicited Injection-site Adverse Events
timeFrame: Up to 7 days after any vaccination, up to a total of ~ 13 months
measure: Percentage of Participants With ≥1 Solicited Systemic Adverse Events
timeFrame: Up to 7 days after any vaccination, up to a total of ~ 13 months
measure: Percentage of Participants With ≥1 Vaccine-related Serious Adverse Events
timeFrame: Up to approximately 14.5 months
measure: Percentage of Participants Discontinuing Study Therapy Due to an Adverse Event
timeFrame: Up to approximately 13 months
measure: Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G ≥0.35 µg/mL
timeFrame: 30 days after vaccination 3 (Up to a total of ~5 months)
measure: Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 3
timeFrame: 30 days after vaccination 3 (Up to a total of ~5 months)
Secondary outcomes:
measure: Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 4
timeFrame: 30 days after vaccination 4 (Up to a total of ~14 months)
Other outcomes:
Locations:
city: Jeonju-si
country: Korea, Republic of
facility: Jeonbuk National University Hospital ( Site 0008)
state: Jeonrabugdo
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital ( Site 0006)
state: Kyonggi-do
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital ( Site 0011)
state: Kyonggi-do
city: Hwaseong-si
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital ( Site 0013)
state: Kyonggi-do
city: Seongnam si
country: Korea, Republic of
facility: CHA Bundang Medical Center CHA University ( Site 0020)
state: Kyonggi-do
city: Changwon
country: Korea, Republic of
facility: Changwon Fatima Hospital ( Site 0015)
state: Kyongsangnam-do
city: Yangsan-si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital ( Site 0009)
state: Kyongsangnam-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital ( Site 0014)
state: Taegu-Kwangyokshi
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 0012)
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center ( Site 0019)
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital ( Site 0001)
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital ( Site 0017)
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University ( Site 0005)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 0002)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 0007)
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea ( Site 0003)
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital ( Site 0016)
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Seoul Hospital ( Site 0010)
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital ( Site 0021)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Maestri A, Park SE, Fernandes F, Li ZL, Kim YJ, Kim YK, Lee J, Park JY, Kim DH, Yang G, Lim H, Kim JO, Lupinacci R, Sterling TM, Wilck M, Esteves-Jaramillo A, Banniettis N. A phase 3, single-arm, open-label study to evaluate the safety, tolerability, and immunogenicity of a 15-valent pneumococcal conjugate vaccine, V114, in a 3+1 regimen in healthy infants in South Korea (PNEU-PED-KOR). Hum Vaccin Immunother. 2024 Dec 31;20(1):2321035. doi: 10.1080/21645515.2024.2321035. Epub 2024 Mar 18.