Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033)
- Conditions
- Pneumococcal Infections
- Interventions
- Biological: V114Biological: PCV13
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 694
- Japanese male or female
- 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
- Arm && Interventions
Group Intervention Description V114 V114 Participants will receive a single 0.5 mL subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age. Pneumococcal 13-valent Conjugate Vaccine (PCV13) PCV13 Participants will receive a single 0.5 mL subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age.
- 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)
National Hospital Organization Sendai Medical Center ( Site 3311)
🇯🇵Sendai, Miyagi, Japan
INAMITSU Children's Clinic ( Site 3321)
🇯🇵Fukuoka, Japan
Fukui Aiiku Hospital ( Site 3315)
🇯🇵Fukui, Japan
Sotobo Children's Clinic ( Site 3323)
🇯🇵Isumi, Chiba, Japan
Social Medical Corporation Koujunkai Daido Clinic ( Site 3326)
🇯🇵Nagoya, Aichi, Japan
Morinaga Maternity Clinic ( Site 3345)
🇯🇵Kasugai, Aichi, Japan
Yokoyama Children's Clinic ( Site 3309)
🇯🇵Kasuga, Fukuoka, Japan
Chugoku Rosai Hospital ( Site 3340)
🇯🇵Kure, Hiroshima, Japan
Kyoritsu Narashinodai Hospital ( Site 3332)
🇯🇵Funabashi, Chiba, Japan
Tsuchiura Kyodo General Hospital ( Site 3327)
🇯🇵Tsuchiura, Ibaraki, Japan
Kagoshima Children's Hospital ( Site 3342)
🇯🇵Hioki, Kagoshima, Japan
JOHAS Yokohama Rosai Hospital ( Site 3343)
🇯🇵Yokohama, Kanagawa, Japan
National Hospital Organization Sagamihara National Hospital ( Site 3303)
🇯🇵Sagamihara, Kanagawa, Japan
Ina Central Hospital ( Site 3346)
🇯🇵Ina, Nagano, Japan
Kawasaki Municipal Hospital ( Site 3302)
🇯🇵Kawasaki, Kanagawa, Japan
National Hospital Organization Mie Chuo Medical Center ( Site 3308)
🇯🇵Tsu, Mie, Japan
Aizawa Hospital ( Site 3313)
🇯🇵Matsumoto, Nagano, Japan
Taniguchi Hospital ( Site 3310)
🇯🇵Izumisano, Osaka, Japan
Saiseikai Kawaguchi General Hospital ( Site 3304)
🇯🇵Kawaguchi, Saitama, Japan
Hara Children's Clinic ( Site 3339)
🇯🇵Tokorozawa, Saitama, Japan
Medical corporation Waffle GunGunkids Clinic ( Site 3329)
🇯🇵Sakai, Osaka, Japan
Aiwa Hospital ( Site 3336)
🇯🇵Kawagoe, Saitama, Japan
Suita Municipal Hospital ( Site 3338)
🇯🇵Suita, Osaka, Japan
Takatsuki General Hospital ( Site 3318)
🇯🇵Takatsuki, Osaka, Japan
Kobayashi Pediatric Clinic ( Site 3301)
🇯🇵Fujieda, Shizuoka, Japan
Nishida Kodomo Clinic ( Site 3306)
🇯🇵Tama, Tokyo, Japan
Saiseikai Shiga Hospital ( Site 3349)
🇯🇵Ritto, Shiga, Japan
Fukui-ken Saiseikai Hospital ( Site 3314)
🇯🇵Fukui, Japan
National Hospital Organization Saitama Hospital ( Site 3312)
🇯🇵Wako, Saitama, Japan
Saiwai Kodomo Clinic ( Site 3331)
🇯🇵Tachikawa, Tokyo, Japan
Shindo Children's Clinic ( Site 3325)
🇯🇵Fukuoka, Japan
Kurokawa Michiko Pediatric Clinic ( Site 3319)
🇯🇵Fukuoka, Japan
Shimomura Pediatrics Clinic ( Site 3320)
🇯🇵Fukuoka, Japan
Kubota Children's Clinic ( Site 3334)
🇯🇵Osaka, Japan
Nagamine Soyokaze Clinic ( Site 3348)
🇯🇵Kumamoto, Japan
Minaminagano Medical Center Shinonoi General Hospital ( Site 3344)
🇯🇵Nagano, Japan
Saiseikai Noe Hospital ( Site 3330)
🇯🇵Osaka, Japan
Aizenbashi Hospital ( Site 3317)
🇯🇵Osaka, Japan
Japanese Red Cross Shizuoka Hospital ( Site 3322)
🇯🇵Shizuoka, Japan
Hosaka Children's Clinic ( Site 3307)
🇯🇵Tokyo, Japan
Sano Kids Clinic ( Site 3341)
🇯🇵Osaka, Japan
Shizuoka City Shimizu Hospital ( Site 3347)
🇯🇵Shizuoka, Japan
The Fraternity Memorial Hospital ( Site 3333)
🇯🇵Tokyo, Japan
Okawa Children & Family Clinic ( Site 3305)
🇯🇵Tokyo, Japan
Toyama City Hospital ( Site 3328)
🇯🇵Toyama, Japan