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

Primary Purpose

Pneumococcal Disease

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
V114
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Disease

Eligibility Criteria

42 Days - 90 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jeonbuk National University Hospital ( Site 0008)
  • Korea University Ansan Hospital ( Site 0006)
  • Hallym University Sacred Heart Hospital ( Site 0011)
  • Hallym University Dongtan Sacred Heart Hospital ( Site 0013)
  • CHA Bundang Medical Center CHA University ( Site 0020)
  • Changwon Fatima Hospital ( Site 0015)
  • Pusan National University Yangsan Hospital ( Site 0009)
  • Kyungpook National University Hospital ( Site 0014)
  • The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 0012)
  • Gachon University Gil Medical Center ( Site 0019)
  • Inha University Hospital ( Site 0001)
  • Korea Cancer Center Hospital ( Site 0017)
  • Nowon Eulji Medical Center, Eulji University ( Site 0005)
  • Severance Hospital Yonsei University Health System ( Site 0002)
  • Samsung Medical Center ( Site 0007)
  • The Catholic University of Korea ( Site 0003)
  • Chung-Ang University Hospital ( Site 0016)
  • Ewha Womans University Seoul Hospital ( Site 0010)
  • Korea University Guro Hospital ( Site 0021)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

V114

Arm Description

Participants receive 4 total doses of V114, administered at ~2, 4, 6, and 12-15 months of age.

Outcomes

Primary Outcome Measures

Percentage of participants with ≥1 solicited injection-site adverse events (AEs)
Solicited injection-site AEs consist of swelling, redness, pain or tenderness, and hard lump.
Percentage of participants with ≥1 solicited systemic AEs
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)
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)
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
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
The GMCs of each serotype-specific IgG will be reported.

Secondary Outcome Measures

Geometric mean concentrations (GMCs) of anti-PnPs serotype-specific IgG
The GMCs of each serotype-specific IgG will be reported.

Full Information

First Posted
November 11, 2020
Last Updated
December 22, 2022
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04633226
Brief Title
Safety and Immunogenicity of V114 in Healthy Infants in South Korea (V114-036)
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
November 4, 2022 (Actual)
Study Completion Date
November 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
V114
Arm Type
Experimental
Arm Description
Participants receive 4 total doses of V114, administered at ~2, 4, 6, and 12-15 months of age.
Intervention Type
Biological
Intervention Name(s)
V114
Other Intervention Name(s)
VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine
Intervention Description
V114 0.5 mL sterile suspension for intramuscular injection.
Primary Outcome Measure Information:
Title
Percentage of participants with ≥1 solicited injection-site adverse events (AEs)
Description
Solicited injection-site AEs consist of swelling, redness, pain or tenderness, and hard lump.
Time Frame
Up to 7 days after any vaccination
Title
Percentage of participants with ≥1 solicited systemic AEs
Description
Solicited systemic AEs consist of irritability, drowsiness, loss of appetite, and hives or welts.
Time Frame
Up to 7 days after any vaccination
Title
Percentage of participants with ≥1 vaccine-related serious adverse events (SAEs)
Description
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.
Time Frame
Up to approximately 14.5 months
Title
Percentage of participants discontinuing study therapy due to AE(s)
Description
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.
Time Frame
Up to 13 months
Title
Percentage of participants with anti-pneumococcal polysaccharides (PnPs) serotype-specific immunoglobulin G (IgG) ≥0.35 µg/mL
Description
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.
Time Frame
30 days after vaccination 3
Title
Geometric mean concentrations (GMCs) of anti-PnPs serotype-specific IgG
Description
The GMCs of each serotype-specific IgG will be reported.
Time Frame
30 days after vaccination 3
Secondary Outcome Measure Information:
Title
Geometric mean concentrations (GMCs) of anti-PnPs serotype-specific IgG
Description
The GMCs of each serotype-specific IgG will be reported.
Time Frame
30 days after vaccination 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Days
Maximum Age & Unit of Time
90 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Jeonbuk National University Hospital ( Site 0008)
City
Jeonju-si
State/Province
Jeonrabugdo
ZIP/Postal Code
54907
Country
Korea, Republic of
Facility Name
Korea University Ansan Hospital ( Site 0006)
City
Ansan-si
State/Province
Kyonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
Hallym University Sacred Heart Hospital ( Site 0011)
City
Anyang-si
State/Province
Kyonggi-do
ZIP/Postal Code
14068
Country
Korea, Republic of
Facility Name
Hallym University Dongtan Sacred Heart Hospital ( Site 0013)
City
Hwaseong-si
State/Province
Kyonggi-do
ZIP/Postal Code
18450
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center CHA University ( Site 0020)
City
Seongnam si
State/Province
Kyonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Changwon Fatima Hospital ( Site 0015)
City
Changwon
State/Province
Kyongsangnam-do
ZIP/Postal Code
51394
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital ( Site 0009)
City
Yangsan-si
State/Province
Kyongsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital ( Site 0014)
City
Daegu
State/Province
Taegu-Kwangyokshi
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 0012)
City
Incheon
ZIP/Postal Code
21431
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center ( Site 0019)
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Inha University Hospital ( Site 0001)
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Korea Cancer Center Hospital ( Site 0017)
City
Seoul
ZIP/Postal Code
01812
Country
Korea, Republic of
Facility Name
Nowon Eulji Medical Center, Eulji University ( Site 0005)
City
Seoul
ZIP/Postal Code
01830
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System ( Site 0002)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center ( Site 0007)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea ( Site 0003)
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital ( Site 0016)
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Facility Name
Ewha Womans University Seoul Hospital ( Site 0010)
City
Seoul
ZIP/Postal Code
07804
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital ( Site 0021)
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php

Learn more about this trial

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

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