Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033)

Pneumococcal Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04384107
• Other study ID #: V114-033
• Secondary ID: V114-03320528720
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: July 2023
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 694
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Pneumococcal Infections

Intervention

Biological:
• V114
15-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in PCV13 plus 2 additional serotypes (22F, 33F) in each subcutaneous 0.5 mL single dose.
• PCV13
13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in each subcutaneous 0.5 mL single dose.

Locations

Country	Name	City	State
Japan	Kobayashi Pediatric Clinic ( Site 3301)	Fujieda	Shizuoka
Japan	Fukui Aiiku Hospital ( Site 3315)	Fukui
Japan	Fukui-ken Saiseikai Hospital ( Site 3314)	Fukui
Japan	INAMITSU Children's Clinic ( Site 3321)	Fukuoka
Japan	Kurokawa Michiko Pediatric Clinic ( Site 3319)	Fukuoka
Japan	Shimomura Pediatrics Clinic ( Site 3320)	Fukuoka
Japan	Shindo Children's Clinic ( Site 3325)	Fukuoka
Japan	Kyoritsu Narashinodai Hospital ( Site 3332)	Funabashi	Chiba
Japan	Kagoshima Children's Hospital ( Site 3342)	Hioki	Kagoshima
Japan	Ina Central Hospital ( Site 3346)	Ina	Nagano
Japan	Sotobo Children's Clinic ( Site 3323)	Isumi	Chiba
Japan	Taniguchi Hospital ( Site 3310)	Izumisano	Osaka
Japan	Yokoyama Children's Clinic ( Site 3309)	Kasuga	Fukuoka
Japan	Morinaga Maternity Clinic ( Site 3345)	Kasugai	Aichi
Japan	Aiwa Hospital ( Site 3336)	Kawagoe	Saitama
Japan	Saiseikai Kawaguchi General Hospital ( Site 3304)	Kawaguchi	Saitama
Japan	Kawasaki Municipal Hospital ( Site 3302)	Kawasaki	Kanagawa
Japan	Nagamine Soyokaze Clinic ( Site 3348)	Kumamoto
Japan	Chugoku Rosai Hospital ( Site 3340)	Kure	Hiroshima
Japan	Aizawa Hospital ( Site 3313)	Matsumoto	Nagano
Japan	Minaminagano Medical Center Shinonoi General Hospital ( Site 3344)	Nagano
Japan	Social Medical Corporation Koujunkai Daido Clinic ( Site 3326)	Nagoya	Aichi
Japan	Aizenbashi Hospital ( Site 3317)	Osaka
Japan	Kubota Children's Clinic ( Site 3334)	Osaka
Japan	Saiseikai Noe Hospital ( Site 3330)	Osaka
Japan	Sano Kids Clinic ( Site 3341)	Osaka
Japan	Saiseikai Shiga Hospital ( Site 3349)	Ritto	Shiga
Japan	National Hospital Organization Sagamihara National Hospital ( Site 3303)	Sagamihara	Kanagawa
Japan	Medical corporation Waffle GunGunkids Clinic ( Site 3329)	Sakai	Osaka
Japan	National Hospital Organization Sendai Medical Center ( Site 3311)	Sendai	Miyagi
Japan	Japanese Red Cross Shizuoka Hospital ( Site 3322)	Shizuoka
Japan	Shizuoka City Shimizu Hospital ( Site 3347)	Shizuoka
Japan	Suita Municipal Hospital ( Site 3338)	Suita	Osaka
Japan	Saiwai Kodomo Clinic ( Site 3331)	Tachikawa	Tokyo
Japan	Takatsuki General Hospital ( Site 3318)	Takatsuki	Osaka
Japan	Nishida Kodomo Clinic ( Site 3306)	Tama	Tokyo
Japan	Hara Children's Clinic ( Site 3339)	Tokorozawa	Saitama
Japan	Hosaka Children's Clinic ( Site 3307)	Tokyo
Japan	Okawa Children & Family Clinic ( Site 3305)	Tokyo
Japan	The Fraternity Memorial Hospital ( Site 3333)	Tokyo
Japan	Toyama City Hospital ( Site 3328)	Toyama
Japan	National Hospital Organization Mie Chuo Medical Center ( Site 3308)	Tsu	Mie
Japan	Tsuchiura Kyodo General Hospital ( Site 3327)	Tsuchiura	Ibaraki
Japan	National Hospital Organization Saitama Hospital ( Site 3312)	Wako	Saitama
Japan	JOHAS Yokohama Rosai Hospital ( Site 3343)	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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 3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With 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 injection with either V114 or PCV13 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, induration, pain, and swelling.	Day 1 to Day 14 post any vaccination, up to a total of 13.5 months
Primary	Percentage of Participants With Solicited Systemic Adverse Events	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. Following any of the injections with either V114 or PCV13, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were decreased appetite, irritability, somnolence, and urticaria.	Day 1 to Day 14 post any vaccination, up to a total of 13.5 months
Primary	Percentage of Participants With 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 dose 1 (with either V114 or PCV13) was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 through completion of study.	~1 month after Dose 4, up to a total of 14 months
Primary	Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of =0.35 µg/mL for Each Serotype in V114 After Dose 3	The anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin G (IgG) response rates (percentage of participants meeting serotype-specific IgG threshold value of =0.35 µg/mL of participants administered V114 versus participants administered PCV13) for the 15 serotypes contained in V114 were determined using an electrochemiluminescence assay.	30 Days after Dose 3, up to a total of 11 months
Primary	Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3	The anti-PnPs serotype-specific IgG Geometric Mean Concentrations (GMCs) of participants administered V114 versus participants administered PCV13 for the 13 serotypes shared in V114 and PCV13 were determined using an electrochemiluminescence assay.	30 Days after Dose 3, up to a total of 11 months
Secondary	GMC of Serotype-Specific IgG for the 2 Unique V114 Serotypes After Dose 3	The anti-PnPs serotype-specific IgG GMCs of participants administered V114 versus participants administered PCV13 for the 2 unique V114 serotypes was determined using an electrochemiluminescence assay.	30 days after Dose 3, up to a total of 11 months
Secondary	Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of =0.35 µg/mL for Each Serotype in V114 After Dose 4	The anti-PnPs serotype-specific IgG response rates (percentage of participants meeting serotype-specific IgG threshold value of =0.35 µg/mL of participants administered V114 versus participants administered PCV13) for the 15 serotypes contained in V114 were determined using an electrochemiluminescence assay.	30 Days after Dose 4, up to a total of 14 months
Secondary	GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4	The anti-PnPs serotype-specific IgG GMCs of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using an electrochemiluminescence assay.	30 Days after Dose 4, up to a total of 14 months
Secondary	Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3	The anti-PnPs serotype-specific opsonophagocytic activity (OPA) and geometric mean titers (GMTs) of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using a multiplexed opsonophagocytic assay.	30 Days after Dose 3, up to a total of 11 months
Secondary	GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4	The anti-PnPs serotype-specific opsonophagocytic activity (OPA) and geometric mean titers (GMTs) of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using a multiplexed opsonophagocytic assay.	30 Days after Dose 4, up to a total of 14 months