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

Pneumococcal Disease Clinical Trial

— PNEU-PED-KOR  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04633226
• Other study ID #: V114-036
• Secondary ID: V114-0362020-003
• Status: Completed
• Phase: Phase 3
• Start date: February 10, 2021
• Est. completion date: November 4, 2022

Study information

• Verified date: April 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 4, 2022
• Est. primary completion date: November 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 42 Days to 90 Days

Eligibility

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

Related Conditions & MeSH terms

• Pneumococcal Disease
• Pneumococcal Infections

Intervention

Biological:
• V114
15-valent pneumococcal conjugate vaccine (PCV) containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in Prevnar 13™ plus 2 additional serotypes (22F, 33F) in each 0.5 mL sterile suspension for intramuscular injection.

Locations

Country	Name	City	State
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	Changwon Fatima Hospital ( Site 0015)	Changwon	Kyongsangnam-do
Korea, Republic of	Kyungpook National University Hospital ( Site 0014)	Daegu	Taegu-Kwangyokshi
Korea, Republic of	Hallym University Dongtan Sacred Heart Hospital ( Site 0013)	Hwaseong-si	Kyonggi-do
Korea, Republic of	Gachon University Gil Medical Center ( Site 0019)	Incheon
Korea, Republic of	Inha University Hospital ( Site 0001)	Incheon
Korea, Republic of	The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 0012)	Incheon
Korea, Republic of	Jeonbuk National University Hospital ( Site 0008)	Jeonju-si	Jeonrabugdo
Korea, Republic of	CHA Bundang Medical Center CHA University ( Site 0020)	Seongnam si	Kyonggi-do
Korea, Republic of	Chung-Ang University Hospital ( Site 0016)	Seoul
Korea, Republic of	Ewha Womans University Seoul Hospital ( Site 0010)	Seoul
Korea, Republic of	Korea Cancer Center Hospital ( Site 0017)	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	Samsung Medical Center ( Site 0007)	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System ( Site 0002)	Seoul
Korea, Republic of	The Catholic University of Korea ( Site 0003)	Seoul
Korea, Republic of	Pusan National University Yangsan Hospital ( Site 0009)	Yangsan-si	Kyongsangnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With =1 Solicited Injection-site Adverse Events	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.	Up to 7 days after any vaccination, up to a total of ~ 13 months
Primary	Percentage of Participants With =1 Solicited Systemic Adverse Events	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.	Up to 7 days after any vaccination, up to a total of ~ 13 months
Primary	Percentage of Participants With =1 Vaccine-related Serious Adverse Events	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.	Up to approximately 14.5 months
Primary	Percentage of Participants Discontinuing Study Therapy Due to an Adverse Event	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.	Up to approximately 13 months
Primary	Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G =0.35 µg/mL	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.	30 days after vaccination 3 (Up to a total of ~5 months)
Primary	Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 3	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.	30 days after vaccination 3 (Up to a total of ~5 months)
Secondary	Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 4	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.	30 days after vaccination 4 (Up to a total of ~14 months)

External Links

•   Merck Clinical Trials Information
•   Plain Language Summary