Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine (V116) in Japanese Adults (V116-002)

NCT ID: NCT04665050

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-04
• Study Completion Date: 2021-04-06

Brief Summary

The purpose of this study is to compare the safety, tolerability, and immunogenicity of a polyvalent pneumococcal conjugate vaccine (V116) with that of PNEUMOVAX™23 in healthy Japanese adults.

Conditions

Pneumococcal Infection

Study Design

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

Study Groups

V116

Participants receive a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.

Group Type: EXPERIMENTAL

V116

Intervention Type: BIOLOGICAL

Pneumococcal 21-valent conjugate vaccine with 2 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution

PNEUMOVAX™23

Participants receive a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.

Group Type: ACTIVE_COMPARATOR

PNEUMOVAX™23

Intervention Type: BIOLOGICAL

Pneumococcal 23-valent polyvalent vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution

Interventions

V116

Pneumococcal 21-valent conjugate vaccine with 2 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution

Intervention Type: BIOLOGICAL

PNEUMOVAX™23

Pneumococcal 23-valent polyvalent vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution

Intervention Type: BIOLOGICAL

Other Intervention Names

Polyvalent pneumococcal conjugate vaccine (pPCV); Pneumococcal 21-valent Conjugate Vaccine; PPSV23

Eligibility Criteria

Inclusion Criteria

• is a healthy Japanese male or female ≥20 years of age at time of randomization
• male participants must agree to be abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention
• female participants must not be pregnant or breastfeeding, and is either:
• not a woman of childbearing potential (WOCBP) or
• a WOCBP who agrees to remain abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention

Exclusion Criteria

• has a history of invasive pneumococcal disease (IPD) within 3 years of Day 1
• has a known hypersensitivity to any vaccine components
• has impaired immunological function
• has a coagulation disorder
• had a recent febrile illness (axillary temperature ≥37.5°C or equivalent) within 72 hours before Day 1
• has a known malignancy that is progressing/requiring treatment
• has received, or is expected to receive, a pneumococcal vaccine outside the study protocol
• has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed the regimen for ≥30 days prior to Day 1
• is receiving immunosuppressive therapy
• has received any non-live vaccine from 14 days prior to Day 1 other than inactivated influenza vaccine
• has received any live vaccine from 30 days prior to Day 1
• has received a blood transfusion or blood products
• has participated in another clinical trial within 2 months of this study
• has clinically relevant drug or alcohol abuse
• has any condition that, in the opinion of the investigator, precludes participation in this study

• Minimum Eligible Age: 20 Years
• 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

Souseikai PS Clinic ( Site 0201)

Fukuoka, , Japan

Souseikai Nishikumamoto Hospital ( Site 0202)

Kumamoto, , Japan

Countries

Japan

References

Haranaka M, Yono M, Kishino H, Igarashi R, Oshima N, Sawata M, Platt HL. Safety, tolerability, and immunogenicity of a 21-valent pneumococcal conjugate vaccine, V116, in Japanese healthy adults: A Phase I study. Hum Vaccin Immunother. 2023 Aug 1;19(2):2228162. doi: 10.1080/21645515.2023.2228162.

Reference Type: RESULT

PMID: 37389808 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

pPCV-002

Identifier Type: OTHER

Identifier Source: secondary_id

jRCT2071200094

Identifier Type: REGISTRY

Identifier Source: secondary_id

V116-002

Identifier Type: OTHER

Identifier Source: secondary_id

pPCV-002

Identifier Type: -

Identifier Source: org_study_id