Clinical trial NCT03848065: Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-028)
Official title: A Phase I, Double-Blind, Randomized, Multicenter Trial of the Safety,Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pneumococcal Infections
Keywords: Pneumococcal Vaccines
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2019-02-20
Enrollment: 133
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Meets one or more of the following systemic corticosteroid exclusion criteria: has received systemic corticosteroids (equivalent of ≥ 2 mg/kg total daily dose of prednisone or ≥ 20 mg/d for persons weighing \> 10 kg) for ≥ 14 consecutive days and has not completed this course of treatment at least 30 days prior to trial randomization, has received systemic corticosteroids within 14 days prior to the first dose of study vaccine at randomization, and is expected to require systemic corticosteroids (equivalent of ≥ 2 mg/kg total daily dose of prednisone or ≥ 20 mg/d for persons weighing \> 10 kg) for ≥ 14 consecutive days within 14 days prior to or 30 days after each vaccination during conduct of the study.(Topical, ophthalmic and inhaled steroids are permitted.)
* 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.
* Has received a blood transfusion or blood products, including immunoglobulins before receipt of first dose of study vaccine.
* Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included; these will be reviewed on a case by case basis for approval by the Sponsor.
* Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study. (Refer to the Vaccination Guideline in Japan). Reasons may include, but are not limited to, being unable to keep appointments or planning to relocate during the study.
* Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

Primary outcomes:
measure: Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
timeFrame: Day 1 to Day 14 post each vaccination
measure: Percentage of Participants With a Solicited Systemic Adverse Event
timeFrame: Day 1 to Day 14 post each vaccination
measure: Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)
timeFrame: Up to 4 weeks post vaccination 4 (~14.5 months)
Secondary outcomes:
measure: Percentage of Participants Meeting the Serotype-specific Immunoglobulin G (IgG) Threshold of ≥0.35 µg/mL
timeFrame: One month post vaccination 3 (~3 months after Vaccination 1)
measure: Serotype-specific IgG Geometric Mean Concentrations (GMCs)
timeFrame: 1 month post vaccination 3 (~3 months after Vaccination 1)
measure: 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)
timeFrame: 1 month post vaccination 3 (~3 months after Vaccination 1)
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Meitetsu Hospital ( Site 2805)
state: Aichi
city: Isumi
country: Japan
facility: Sotobo Children's Clinic ( Site 2807)
state: Chiba
city: Dazaifu
country: Japan
facility: Hidaka Children's Clinic ( Site 2803)
state: Fukuoka
city: Isesaki
country: Japan
facility: Isesaki Municipal Hospital ( Site 2806)
state: Gunma
city: Kawasaki
country: Japan
facility: Kawasaki Municipal Hospital ( Site 2802)
state: Kanagawa
city: Yokosuka
country: Japan
facility: Yokosuka Kyosai Hospital ( Site 2804)
state: Kanagawa
city: Suita
country: Japan
facility: Suita Municipal Hospital ( Site 2801)
state: Osaka
city: Fujieda
country: Japan
facility: Kobayashi Pediatric Clinic ( Site 2816)
state: Shizuoka
city: Tama
country: Japan
facility: Nishida Kodomo Clinic ( Site 2811)
state: Tokyo
city: Fukui
country: Japan
facility: Fukui Aiiku Hospital ( Site 2809)
city: Fukui
country: Japan
facility: Fukui-ken Saiseikai Hospital ( Site 2813)
city: Osaka
country: Japan
facility: Kubota Children's Clinic ( Site 2815)
city: Shizuoka
country: Japan
facility: Japanese Red Cross Shizuoka Hospital ( Site 2817)
city: Tokyo
country: Japan
facility: Hosaka Children's Clinic ( Site 2814)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Wan 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.