Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-028)
A Phase I, Double-Blind, Randomized, Multicenter Trial of the Safety,Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants
2 other identifiers
interventional
133
1 country
14
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 administered subcutaneously or intramuscularly in healthy Japanese infants (3 months of age).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2019
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2019
CompletedFirst Posted
Study publicly available on registry
February 20, 2019
CompletedStudy Start
First participant enrolled
April 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2020
CompletedResults Posted
Study results publicly available
October 11, 2023
CompletedJanuary 15, 2025
January 1, 2025
1.2 years
February 19, 2019
December 9, 2022
January 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
An 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. Solicited injection-site AEs were injection site erythema (redness), injection site induration (hard lump), injection site pain and injection site swelling.
Day 1 to Day 14 post each vaccination
Percentage of Participants With a Solicited Systemic Adverse Event
An 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. Solicited systemic AEs were decreased appetite (appetite loss), somnolence (drowsiness), irritability and urticaria (hives/welts).
Day 1 to Day 14 post each vaccination
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)
An 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. Relatedness of an SAE to the study vaccine was determined by the investigator.
Up to 4 weeks post vaccination 4 (~14.5 months)
Secondary Outcomes (3)
Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL
One month post vaccination 3 (~3 months after Vaccination 1)
Serotype-specific IgG Geometric Mean Concentrations (GMCs)
1 month post vaccination 3 (~3 months after Vaccination 1)
Percentage of Participants Meeting Threshold Values for Protective Responses to DTaP-IPV (Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA) and Polio Virus Type 1/2/3)
1 month post vaccination 3 (~3 months after Vaccination 1)
Study Arms (3)
V114-SC
EXPERIMENTALInfant participants will receive a single 0.5 mL subcutaneous (SC) injection of V114 on Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age). Infant participants will receive a single 0.5 mL SC injection of concomitant study vaccine \[Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV) at the same time as V114-SC.
V114-IM
EXPERIMENTALInfant participants will receive a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age). Infant participants will receive a single 0.5 mL SC injection of concomitant study vaccine (DTaP-IPV) at the same time as V114-IM.
PCV13-SC
ACTIVE COMPARATORInfant participants will receive a single 0.5 mL subcutaneous (SC) injection of pneumococcal 13-valent conjugate vaccine (PCV13) at Visit 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age). Infant participants will receive a single 0.5 mL SC injection of concomitant study vaccine (DTaP-IPV) at the same time as PCV13-SC.
Interventions
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B in each 0.5. mL dose.
Single SC dose of 0.5 mL at Visits 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
Eligibility Criteria
You may qualify if:
- Healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator.
- Male or female 3 months of age inclusive (3 months of age to1 day prior to 4 months of age), at the time of obtaining the informed consent.
- Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.
You may not qualify if:
- Has a history of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
- Has a known hypersensitivity to vaccines, any component of the pneumococcal conjugate vaccine or any diphtheria toxoid-containing vaccine
- Has any contraindication to the PCV13 and/or diphtheria, tetanus, acellular pertussis, inactivated polio vaccine (DTaP-IPV) being administered in the study (Refer to approved labeling for contraindication details on PCV13 and DTaPIPV vaccine).
- Has a recent febrile illness (axillary temperature ≥37.5°C) occurring within 72 hours prior to receipt of study vaccine.
- Has a known or suspected impairment of immunological function.
- Has a history of congenital or acquired immunodeficiency.
- Has or his/her mother has a documented hepatitis B surface antigen - positive test.
- Has a known functional or anatomic asplenia.
- Has failure to thrive based on the clinical judgement of the investigator.
- Has thrombocytopenia or a known coagulation disorder contraindicating intramuscular vaccination.
- Has a history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Bechet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders).
- Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders.
- Has received a dose of any pneumococcal and/or DTaP-IPV vaccine (or vaccine containing any DTaP-IPV component) prior to study entry.
- Has received other licensed non-live vaccines within the 14 days before receipt of first dose of study vaccine.
- Has received a licensed live virus vaccine within the 28 days before receipt of first dose of study vaccine.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Meitetsu Hospital ( Site 2805)
Nagoya, Aichi-ken, 451-8511, Japan
Sotobo Children's Clinic ( Site 2807)
Isumi, Chiba, 299-4503, Japan
Hidaka Children's Clinic ( Site 2803)
Dazaifu, Fukuoka, 818-0134, Japan
Isesaki Municipal Hospital ( Site 2806)
Isesaki, Gunma, 372-0817, Japan
Kawasaki Municipal Hospital ( Site 2802)
Kawasaki, Kanagawa, 210-0013, Japan
Yokosuka Kyosai Hospital ( Site 2804)
Yokosuka, Kanagawa, 238-8558, Japan
Suita Municipal Hospital ( Site 2801)
Suita, Osaka, 564-8567, Japan
Kobayashi Pediatric Clinic ( Site 2816)
Fujieda, Shizuoka, 426-0067, Japan
Nishida Kodomo Clinic ( Site 2811)
Tama, Tokyo, 206-0025, Japan
Fukui Aiiku Hospital ( Site 2809)
Fukui, 910-0833, Japan
Fukui-ken Saiseikai Hospital ( Site 2813)
Fukui, 918-8503, Japan
Kubota Children's Clinic ( Site 2815)
Osaka, 544-0033, Japan
Japanese Red Cross Shizuoka Hospital ( Site 2817)
Shizuoka, 420-0853, Japan
Hosaka Children's Clinic ( Site 2814)
Tokyo, 112-0001, Japan
Related Publications (2)
Ishihara Y, Kuroki H, Hidaka H, Iwai K, Wan K, Shirakawa M, Sawata M. Safety and immunogenicity of a 15-valent pneumococcal conjugate vaccine in Japanese healthy infants: A Phase I study (V114-028). Hum Vaccin Immunother. 2023 Dec 31;19(1):2180973. doi: 10.1080/21645515.2023.2180973. Epub 2023 Mar 7.
PMID: 36882898RESULTWan K, Shirakawa M, Sawata M. Descriptive analysis of safety and immunogenicity profiles of a 15-valent pneumococcal conjugate vaccine between subcutaneous and intramuscular administration in a phase 1 study of healthy Japanese infants (V114-028). J Infect Chemother. 2025 Feb;31(2):102539. doi: 10.1016/j.jiac.2024.10.007. Epub 2024 Oct 9.
PMID: 39384037RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme LLC
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2019
First Posted
February 20, 2019
Study Start
April 2, 2019
Primary Completion
June 24, 2020
Study Completion
June 24, 2020
Last Updated
January 15, 2025
Results First Posted
October 11, 2023
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf