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

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.

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.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Disease
• Intervention / Treatment: Biological: V114

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of, 21431
    • The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 0012)
  • Incheon, Korea, Republic of, 21565
    • Gachon University Gil Medical Center ( Site 0019)
  • Incheon, Korea, Republic of, 22332
    • Inha University Hospital ( Site 0001)
  • Seoul, Korea, Republic of, 01812
    • Korea Cancer Center Hospital ( Site 0017)
  • Seoul, Korea, Republic of, 01830
    • Nowon Eulji Medical Center, Eulji University ( Site 0005)
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital Yonsei University Health System ( Site 0002)
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center ( Site 0007)
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea ( Site 0003)
  • Seoul, Korea, Republic of, 06973
    • Chung-Ang University Hospital ( Site 0016)
  • Seoul, Korea, Republic of, 07804
    • Ewha Womans University Seoul Hospital ( Site 0010)
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital ( Site 0021)
  • Jeonrabugdo
    • Jeonju-si, Jeonrabugdo, Korea, Republic of, 54907
      • Jeonbuk National University Hospital ( Site 0008)
  • Kyonggi-do
    • Ansan-si, Kyonggi-do, Korea, Republic of, 15355
      • Korea University Ansan Hospital ( Site 0006)
    • Anyang-si, Kyonggi-do, Korea, Republic of, 14068
      • Hallym University Sacred Heart Hospital ( Site 0011)
    • Hwaseong-si, Kyonggi-do, Korea, Republic of, 18450
      • Hallym University Dongtan Sacred Heart Hospital ( Site 0013)
    • Seongnam si, Kyonggi-do, Korea, Republic of, 13496
      • CHA Bundang Medical Center CHA University ( Site 0020)
  • Kyongsangnam-do
    • Changwon, Kyongsangnam-do, Korea, Republic of, 51394
      • Changwon Fatima Hospital ( Site 0015)
    • Yangsan-si, Kyongsangnam-do, Korea, Republic of, 50612
      • Pusan National University Yangsan Hospital ( Site 0009)
  • Taegu-Kwangyokshi
    • Daegu, Taegu-Kwangyokshi, Korea, Republic of, 41944
      • Kyungpook National University Hospital ( Site 0014)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 months (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: V114; Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age.	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.; Other Names: VAXNEUVANCE™; Pneumococcal 15-Valent Conjugate Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2021
• Primary Completion (Actual): November 4, 2022
• Study Completion (Actual): November 4, 2022

Study Registration Dates

• First Submitted: November 11, 2020
• First Submitted That Met QC Criteria: November 11, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: V114-036 (Other Identifier: Merck); 2020-003181-39 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No