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

Phase 3

Completed

• Conditions: Pneumococcal Infections

• Registration Number: NCT04384107
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-12
• Study Start: 2020-07-01
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Results First Submitted: 2022-09-06
• Results First Submitted QC: 2022-10-26
• Results First Posted: 2022-11-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 694

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Vaccine-Related Serious Adverse Events	~1 month after Dose 4, up to a total of 14 months	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.
Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3	30 Days after Dose 3, up to a total of 11 months	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.
Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3	30 Days after Dose 3, up to a total of 11 months	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.
Percentage of Participants With Solicited Injection-Site Adverse Events	Day 1 to Day 14 post any vaccination, up to a total of 13.5 months	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.
Percentage of Participants With Solicited Systemic Adverse Events	Day 1 to Day 14 post any vaccination, up to a total of 13.5 months	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.

Secondary Outcome Measures

Name	Time	Method
GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4	30 Days after Dose 4, up to a total of 14 months	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.
GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4	30 Days after Dose 4, up to a total of 14 months	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.
GMC of Serotype-Specific IgG for the 2 Unique V114 Serotypes After Dose 3	30 days after Dose 3, up to a total of 11 months	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.
Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4	30 Days after Dose 4, up to a total of 14 months	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.
Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3	30 Days after Dose 3, up to a total of 11 months	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.

Trial Locations

Locations (45)

Morinaga Maternity Clinic ( Site 3345); 🇯🇵 Kasugai, Aichi, Japan

Social Medical Corporation Koujunkai Daido Clinic ( Site 3326); 🇯🇵 Nagoya, Aichi, Japan

Kyoritsu Narashinodai Hospital ( Site 3332); 🇯🇵 Funabashi, Chiba, Japan

Sotobo Children's Clinic ( Site 3323); 🇯🇵 Isumi, Chiba, Japan

Yokoyama Children's Clinic ( Site 3309); 🇯🇵 Kasuga, Fukuoka, Japan

Chugoku Rosai Hospital ( Site 3340); 🇯🇵 Kure, Hiroshima, Japan

Tsuchiura Kyodo General Hospital ( Site 3327); 🇯🇵 Tsuchiura, Ibaraki, Japan

Kagoshima Children's Hospital ( Site 3342); 🇯🇵 Hioki, Kagoshima, Japan

Kawasaki Municipal Hospital ( Site 3302); 🇯🇵 Kawasaki, Kanagawa, Japan

National Hospital Organization Sagamihara National Hospital ( Site 3303); 🇯🇵 Sagamihara, Kanagawa, Japan

Scroll for more (35 remaining)