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

NCT04384107 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: V114-0332052872019-003644-68
• Study Type: interventional
• Target: 694
• Locations: 1 country
• Sites: 45

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.

Conditions

Pneumococcal Infections

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

V114

EXPERIMENTAL

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.

Biological: V114

Pneumococcal 13-valent Conjugate Vaccine (PCV13)

ACTIVE COMPARATOR

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.

Biological: PCV13

Interventions

V114 BIOLOGICAL

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.

Also known as: VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine

V114

PCV13 BIOLOGICAL

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.

Also known as: Prevnar 13™

Pneumococcal 13-valent Conjugate Vaccine (PCV13)

Eligibility Criteria

• Age: 2 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- Japanese male or female

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (45)

Morinaga Maternity Clinic ( Site 3345)

Kasugai, Aichi-ken, 486-0836, Japan

Location

Social Medical Corporation Koujunkai Daido Clinic ( Site 3326)

Nagoya, Aichi-ken, 457-8511, Japan

Location

Kyoritsu Narashinodai Hospital ( Site 3332)

Funabashi, Chiba, 274-0063, Japan

Location

Sotobo Children's Clinic ( Site 3323)

Isumi, Chiba, 299-4503, Japan

Location

Yokoyama Children's Clinic ( Site 3309)

Kasuga, Fukuoka, 816-0801, Japan

Location

Chugoku Rosai Hospital ( Site 3340)

Kure, Hiroshima, 737-0193, Japan

Location

Tsuchiura Kyodo General Hospital ( Site 3327)

Tsuchiura, Ibaraki, 300-0028, Japan

Location

Kagoshima Children's Hospital ( Site 3342)

Hioki, Kagoshima-ken, 899-2503, Japan

Location

Kawasaki Municipal Hospital ( Site 3302)

Kawasaki, Kanagawa, 210-0013, Japan

Location

National Hospital Organization Sagamihara National Hospital ( Site 3303)

Sagamihara, Kanagawa, 252-0392, Japan

Location

JOHAS Yokohama Rosai Hospital ( Site 3343)

Yokohama, Kanagawa, 222-0036, Japan

Location

National Hospital Organization Mie Chuo Medical Center ( Site 3308)

Tsu, Mie-ken, 514-1101, Japan

Location

National Hospital Organization Sendai Medical Center ( Site 3311)

Sendai, Miyagi, 983-8520, Japan

Location

Ina Central Hospital ( Site 3346)

Ina, Nagano, 396-8555, Japan

Location

Aizawa Hospital ( Site 3313)

Matsumoto, Nagano, 390-8510, Japan

Location

Taniguchi Hospital ( Site 3310)

Izumisano, Osaka, 598-0043, Japan

Location

Medical corporation Waffle GunGunkids Clinic ( Site 3329)

Sakai, Osaka, 591-8023, Japan

Location

Suita Municipal Hospital ( Site 3338)

Suita, Osaka, 564-8567, Japan

Location

Takatsuki General Hospital ( Site 3318)

Takatsuki, Osaka, 569-1192, Japan

Location

Aiwa Hospital ( Site 3336)

Kawagoe, Saitama, 350-0001, Japan

Location

Saiseikai Kawaguchi General Hospital ( Site 3304)

Kawaguchi, Saitama, 332-8558, Japan

Location

Hara Children's Clinic ( Site 3339)

Tokorozawa, Saitama, 359-1141, Japan

Location

National Hospital Organization Saitama Hospital ( Site 3312)

Wako, Saitama, 351-0102, Japan

Location

Saiseikai Shiga Hospital ( Site 3349)

Rittō, Shiga, 520-3046, Japan

Location

Kobayashi Pediatric Clinic ( Site 3301)

Fujieda, Shizuoka, 426-0067, Japan

Location

Saiwai Kodomo Clinic ( Site 3331)

Tachikawa, Tokyo, 190-0002, Japan

Location

Nishida Kodomo Clinic ( Site 3306)

Tama, Tokyo, 206-0025, Japan

Location

Fukui Aiiku Hospital ( Site 3315)

Fukui, 910-0833, Japan

Location

Fukui-ken Saiseikai Hospital ( Site 3314)

Fukui, 918-8503, Japan

Location

Shindo Children's Clinic ( Site 3325)

Fukuoka, 814-0121, Japan

Location

Kurokawa Michiko Pediatric Clinic ( Site 3319)

Fukuoka, 815-0033, Japan

Location

Shimomura Pediatrics Clinic ( Site 3320)

Fukuoka, 819-0002, Japan

Location

INAMITSU Children's Clinic ( Site 3321)

Fukuoka, 819-0041, Japan

Location

Nagamine Soyokaze Clinic ( Site 3348)

Kumamoto, 862-0920, Japan

Location

Minaminagano Medical Center Shinonoi General Hospital ( Site 3344)

Nagano, 388-8004, Japan

Location

Saiseikai Noe Hospital ( Site 3330)

Osaka, 536-0001, Japan

Location

Kubota Children's Clinic ( Site 3334)

Osaka, 544-0033, Japan

Location

Sano Kids Clinic ( Site 3341)

Osaka, 553-0001, Japan

Location

Aizenbashi Hospital ( Site 3317)

Osaka, 556-0005, Japan

Location

Japanese Red Cross Shizuoka Hospital ( Site 3322)

Shizuoka, 420-0853, Japan

Location

Shizuoka City Shimizu Hospital ( Site 3347)

Shizuoka, 424-8636, Japan

Location

Hosaka Children's Clinic ( Site 3307)

Tokyo, 112-0001, Japan

Location

The Fraternity Memorial Hospital ( Site 3333)

Tokyo, 130-8587, Japan

Location

Okawa Children & Family Clinic ( Site 3305)

Tokyo, 146-0095, Japan

Location

Toyama City Hospital ( Site 3328)

Toyama, 939-8511, Japan

Location

Related 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 31;41(34):4933-4940. doi: 10.1016/j.vaccine.2023.05.064. Epub 2023 Jun 19.

  PMID: 37344262 RESULT

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 12, 2020
• Study Start: July 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 28, 2023
• Results First Posted: November 15, 2022

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share

Locations

JP (45)