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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
694
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.
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.
Morinaga Maternity Clinic ( Site 3345)
Kasugai, Aichi-ken, Japan
Social Medical Corporation Koujunkai Daido Clinic ( Site 3326)
Nagoya, Aichi-ken, 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
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.
Time frame: Day 1 to Day 14 post any vaccination, up to a total of 13.5 months
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.
Time frame: Day 1 to Day 14 post any vaccination, up to a total of 13.5 months
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.
Time frame: ~1 month after Dose 4, up to a total of 14 months
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.
Time frame: 30 Days after Dose 3, up to a total of 11 months
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.
Time frame: 30 Days after Dose 3, up to a total of 11 months
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.
Time frame: 30 days after Dose 3, up to a total of 11 months
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.
Time frame: 30 Days after Dose 4, up to a total of 14 months
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.
Time frame: 30 Days after Dose 4, up to a total of 14 months
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.
Time frame: 30 Days after Dose 3, up to a total of 11 months
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.
Time frame: 30 Days after Dose 4, up to a total of 14 months
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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-ken, Japan
Kawasaki Municipal Hospital ( Site 3302)
Kawasaki, Kanagawa, Japan
National Hospital Organization Sagamihara National Hospital ( Site 3303)
Sagamihara, Kanagawa, Japan
...and 35 more locations