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

NCT ID: NCT04384107

Last Updated: 2023-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 694 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

V114

Intervention Type: 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.

Pneumococcal 13-valent Conjugate Vaccine (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.

Group Type: ACTIVE_COMPARATOR

PCV13

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

VAXNEUVANCE™; Pneumococcal 15-Valent Conjugate Vaccine; Prevnar 13™

Eligibility Criteria

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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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

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

JOHAS Yokohama Rosai Hospital ( Site 3343)

Yokohama, Kanagawa, Japan

National Hospital Organization Mie Chuo Medical Center ( Site 3308)

Tsu, Mie-ken, Japan

National Hospital Organization Sendai Medical Center ( Site 3311)

Sendai, Miyagi, Japan

Ina Central Hospital ( Site 3346)

Ina, Nagano, Japan

Aizawa Hospital ( Site 3313)

Matsumoto, Nagano, Japan

Taniguchi Hospital ( Site 3310)

Izumisano, Osaka, Japan

Medical corporation Waffle GunGunkids Clinic ( Site 3329)

Sakai, Osaka, Japan

Suita Municipal Hospital ( Site 3338)

Suita, Osaka, Japan

Takatsuki General Hospital ( Site 3318)

Takatsuki, Osaka, Japan

Aiwa Hospital ( Site 3336)

Kawagoe, Saitama, Japan

Saiseikai Kawaguchi General Hospital ( Site 3304)

Kawaguchi, Saitama, Japan

Hara Children's Clinic ( Site 3339)

Tokorozawa, Saitama, Japan

National Hospital Organization Saitama Hospital ( Site 3312)

Wako, Saitama, Japan

Saiseikai Shiga Hospital ( Site 3349)

Rittō, Shiga, Japan

Kobayashi Pediatric Clinic ( Site 3301)

Fujieda, Shizuoka, Japan

Saiwai Kodomo Clinic ( Site 3331)

Tachikawa, Tokyo, Japan

Nishida Kodomo Clinic ( Site 3306)

Tama, Tokyo, Japan

Fukui Aiiku Hospital ( Site 3315)

Fukui, , Japan

Fukui-ken Saiseikai Hospital ( Site 3314)

Fukui, , Japan

Shindo Children's Clinic ( Site 3325)

Fukuoka, , Japan

Kurokawa Michiko Pediatric Clinic ( Site 3319)

Fukuoka, , Japan

Shimomura Pediatrics Clinic ( Site 3320)

Fukuoka, , Japan

INAMITSU Children's Clinic ( Site 3321)

Fukuoka, , 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

Kubota Children's Clinic ( Site 3334)

Osaka, , Japan

Sano Kids Clinic ( Site 3341)

Osaka, , Japan

Aizenbashi Hospital ( Site 3317)

Osaka, , Japan

Japanese Red Cross Shizuoka Hospital ( Site 3322)

Shizuoka, , Japan

Shizuoka City Shimizu Hospital ( Site 3347)

Shizuoka, , Japan

Hosaka Children's Clinic ( Site 3307)

Tokyo, , Japan

The Fraternity Memorial Hospital ( Site 3333)

Tokyo, , Japan

Okawa Children & Family Clinic ( Site 3305)

Tokyo, , Japan

Toyama City Hospital ( Site 3328)

Toyama, , Japan

Countries

Japan

References

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.

Reference Type: RESULT

PMID: 37344262 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

V114-033

Identifier Type: OTHER

Identifier Source: secondary_id

205287

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019-003644-68

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V114-033

Identifier Type: -

Identifier Source: org_study_id