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

NCT04633226 | Completed Phase 3 Results

• 2 other identifiers: V114-0362020-003181-39
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 19

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.

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 4

  30 days after vaccination 4 (Up to a total of ~14 months)

Study Arms (1)

V114

EXPERIMENTAL

Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age.

Biological: V114

Interventions

V114 BIOLOGICAL

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.

Also known as: VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine

V114

Eligibility Criteria

• Age: 42 Days - 90 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (19)

Jeonbuk National University Hospital ( Site 0008)

Jeonju, Jeonrabugdo, 54907, South Korea

Location

Korea University Ansan Hospital ( Site 0006)

Ansan-si, Kyonggi-do, 15355, South Korea

Location

Hallym University Sacred Heart Hospital ( Site 0011)

Anyang-si, Kyonggi-do, 14068, South Korea

Location

Hallym University Dongtan Sacred Heart Hospital ( Site 0013)

Hwaseong-si, Kyonggi-do, 18450, South Korea

Location

CHA Bundang Medical Center CHA University ( Site 0020)

Seongnam-si, Kyonggi-do, 13496, South Korea

Location

Changwon Fatima Hospital ( Site 0015)

Changwon, Kyongsangnam-do, 51394, South Korea

Location

Pusan National University Yangsan Hospital ( Site 0009)

Yangsan, Kyongsangnam-do, 50612, South Korea

Location

Kyungpook National University Hospital ( Site 0014)

Daegu, Taegu-Kwangyokshi, 41944, South Korea

Location

The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 0012)

Incheon, 21431, South Korea

Location

Gachon University Gil Medical Center ( Site 0019)

Incheon, 21565, South Korea

Location

Inha University Hospital ( Site 0001)

Incheon, 22332, South Korea

Location

Korea Cancer Center Hospital ( Site 0017)

Seoul, 01812, South Korea

Location

Nowon Eulji Medical Center, Eulji University ( Site 0005)

Seoul, 01830, South Korea

Location

Severance Hospital Yonsei University Health System ( Site 0002)

Seoul, 03722, South Korea

Location

Samsung Medical Center ( Site 0007)

Seoul, 06351, South Korea

Location

The Catholic University of Korea ( Site 0003)

Seoul, 06591, South Korea

Location

Chung-Ang University Hospital ( Site 0016)

Seoul, 06973, South Korea

Location

Ewha Womans University Seoul Hospital ( Site 0010)

Seoul, 07804, South Korea

Location

Korea University Guro Hospital ( Site 0021)

Seoul, 08308, South Korea

Location

Related Publications (1)

• 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.

  PMID: 38497448 RESULT

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 18, 2020
• Study Start: February 10, 2021
• Primary Completion: November 4, 2022
• Study Completion: November 4, 2022
• Last Updated: September 24, 2024
• Results First Posted: April 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

KR (19)