Clinical trial NCT04384107: Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033)
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2020-05-12
Enrollment: 694
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this clinical study is to evaluate the safety and immunogenicity of a 4-dose schedule (3-dose primary series followed by a toddler dose) of V114 compared with Pneumococcal 13-valent Conjugate Vaccine (PCV13). The hypotheses are that: 1) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on the response rates at 30 days following dose 3; 2) V114 is non-inferior to PCV13 for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes at 30 days following dose 3; 3) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days following dose 3.


Eligibility criteria: Inclusion Criteria:

- Japanese male or female

Exclusion Criteria:

* Has a history of invasive pneumococcal disease (IPD)
* Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid containing 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 human immunodeficiency virus (HIV) infection
* Has or his/her mother has a documented hepatitis B surface antigen-positive test
* Has known or history of functional or anatomic asplenia
* Has a history of autoimmune disease
* Has a known neurologic or cognitive behavioral disorder
* Has received a dose of any pneumococcal vaccine prior to study entry
* Has received a blood transfusion or blood products, including immunoglobulins

Primary outcomes:
measure: Percentage of Participants With Solicited Injection-Site Adverse Events
timeFrame: Day 1 to Day 14 post any vaccination, up to a total of 13.5 months
measure: Percentage of Participants With Solicited Systemic Adverse Events
timeFrame: Day 1 to Day 14 post any vaccination, up to a total of 13.5 months
measure: Percentage of Participants With Vaccine-Related Serious Adverse Events
timeFrame: ~1 month after Dose 4, up to a total of 14 months
measure: Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3
timeFrame: 30 Days after Dose 3, up to a total of 11 months
measure: Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3
timeFrame: 30 Days after Dose 3, up to a total of 11 months
Secondary outcomes:
measure: GMC of Serotype-Specific IgG for the 2 Unique V114 Serotypes After Dose 3
timeFrame: 30 days after Dose 3, up to a total of 11 months
measure: Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4
timeFrame: 30 Days after Dose 4, up to a total of 14 months
measure: GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4
timeFrame: 30 Days after Dose 4, up to a total of 14 months
measure: Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3
timeFrame: 30 Days after Dose 3, up to a total of 11 months
measure: GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4
timeFrame: 30 Days after Dose 4, up to a total of 14 months
Other outcomes:
Locations:
city: Kasugai
country: Japan
facility: Morinaga Maternity Clinic ( Site 3345)
state: Aichi
city: Nagoya
country: Japan
facility: Social Medical Corporation Koujunkai Daido Clinic ( Site 3326)
state: Aichi
city: Funabashi
country: Japan
facility: Kyoritsu Narashinodai Hospital ( Site 3332)
state: Chiba
city: Isumi
country: Japan
facility: Sotobo Children's Clinic ( Site 3323)
state: Chiba
city: Kasuga
country: Japan
facility: Yokoyama Children's Clinic ( Site 3309)
state: Fukuoka
city: Kure
country: Japan
facility: Chugoku Rosai Hospital ( Site 3340)
state: Hiroshima
city: Tsuchiura
country: Japan
facility: Tsuchiura Kyodo General Hospital ( Site 3327)
state: Ibaraki
city: Hioki
country: Japan
facility: Kagoshima Children's Hospital ( Site 3342)
state: Kagoshima
city: Kawasaki
country: Japan
facility: Kawasaki Municipal Hospital ( Site 3302)
state: Kanagawa
city: Sagamihara
country: Japan
facility: National Hospital Organization Sagamihara National Hospital ( Site 3303)
state: Kanagawa
city: Yokohama
country: Japan
facility: JOHAS Yokohama Rosai Hospital ( Site 3343)
state: Kanagawa
city: Tsu
country: Japan
facility: National Hospital Organization Mie Chuo Medical Center ( Site 3308)
state: Mie
city: Sendai
country: Japan
facility: National Hospital Organization Sendai Medical Center ( Site 3311)
state: Miyagi
city: Ina
country: Japan
facility: Ina Central Hospital ( Site 3346)
state: Nagano
city: Matsumoto
country: Japan
facility: Aizawa Hospital ( Site 3313)
state: Nagano
city: Izumisano
country: Japan
facility: Taniguchi Hospital ( Site 3310)
state: Osaka
city: Sakai
country: Japan
facility: Medical corporation Waffle GunGunkids Clinic ( Site 3329)
state: Osaka
city: Suita
country: Japan
facility: Suita Municipal Hospital ( Site 3338)
state: Osaka
city: Takatsuki
country: Japan
facility: Takatsuki General Hospital ( Site 3318)
state: Osaka
city: Kawagoe
country: Japan
facility: Aiwa Hospital ( Site 3336)
state: Saitama
city: Kawaguchi
country: Japan
facility: Saiseikai Kawaguchi General Hospital ( Site 3304)
state: Saitama
city: Tokorozawa
country: Japan
facility: Hara Children's Clinic ( Site 3339)
state: Saitama
city: Wako
country: Japan
facility: National Hospital Organization Saitama Hospital ( Site 3312)
state: Saitama
city: Ritto
country: Japan
facility: Saiseikai Shiga Hospital ( Site 3349)
state: Shiga
city: Fujieda
country: Japan
facility: Kobayashi Pediatric Clinic ( Site 3301)
state: Shizuoka
city: Tachikawa
country: Japan
facility: Saiwai Kodomo Clinic ( Site 3331)
state: Tokyo
city: Tama
country: Japan
facility: Nishida Kodomo Clinic ( Site 3306)
state: Tokyo
city: Fukui
country: Japan
facility: Fukui Aiiku Hospital ( Site 3315)
city: Fukui
country: Japan
facility: Fukui-ken Saiseikai Hospital ( Site 3314)
city: Fukuoka
country: Japan
facility: Shindo Children's Clinic ( Site 3325)
city: Fukuoka
country: Japan
facility: Kurokawa Michiko Pediatric Clinic ( Site 3319)
city: Fukuoka
country: Japan
facility: Shimomura Pediatrics Clinic ( Site 3320)
city: Fukuoka
country: Japan
facility: INAMITSU Children's Clinic ( Site 3321)
city: Kumamoto
country: Japan
facility: Nagamine Soyokaze Clinic ( Site 3348)
city: Nagano
country: Japan
facility: Minaminagano Medical Center Shinonoi General Hospital ( Site 3344)
city: Osaka
country: Japan
facility: Saiseikai Noe Hospital ( Site 3330)
city: Osaka
country: Japan
facility: Kubota Children's Clinic ( Site 3334)
city: Osaka
country: Japan
facility: Sano Kids Clinic ( Site 3341)
city: Osaka
country: Japan
facility: Aizenbashi Hospital ( Site 3317)
city: Shizuoka
country: Japan
facility: Japanese Red Cross Shizuoka Hospital ( Site 3322)
city: Shizuoka
country: Japan
facility: Shizuoka City Shimizu Hospital ( Site 3347)
city: Tokyo
country: Japan
facility: Hosaka Children's Clinic ( Site 3307)
city: Tokyo
country: Japan
facility: The Fraternity Memorial Hospital ( Site 3333)
city: Tokyo
country: Japan
facility: Okawa Children & Family Clinic ( Site 3305)
city: Toyama
country: Japan
facility: Toyama City Hospital ( Site 3328)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Suzuki H, Fujita H, Iwai K, Kuroki H, Taniyama K, Shizuya T, Kishino H, Igarashi R, Shirakawa M, Sawata M. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in Japanese healthy infants: A phase III study (V114-033). Vaccine. 2023 Jul 31;41(34):4933-4940. doi: 10.1016/j.vaccine.2023.05.064. Epub 2023 Jun 19.