Study Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine

NCT ID: NCT02079207

Last Updated: 2016-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 767 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-03-31

Brief Summary

This study will assess the Immunogenicity and safety of 13-valent Pneumococcal Conjugate Vaccine compared with 23-valent Pneumococcal Polysaccharide Vaccine. All participants should be naïve of Pneumococcal vaccine.

Conditions

Pneumococcal Infections

Study Design

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

Study Groups

NBP606

Participants aged over 50 years are given a 0.5mL dose of 13-valent peumococcal conjugate vaccine administered on day 0.

Group Type: EXPERIMENTAL

NBP606

Intervention Type: BIOLOGICAL

13-valent peumococcal conjugate vaccine(13vPnC)

Prodiax-23

Participants aged over 50 years are given a 0.5mL dose of 23-valent pneumococcal polysaccharide vaccine administered on day 0.

Group Type: ACTIVE_COMPARATOR

Prodiax-23

Intervention Type: BIOLOGICAL

23-valent peumococcal polysaccharide vaccine(23vPS)

Interventions

NBP606

13-valent peumococcal conjugate vaccine(13vPnC)

Intervention Type: BIOLOGICAL

Prodiax-23

23-valent peumococcal polysaccharide vaccine(23vPS)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Healthy Male and Female adults over 50 years of age at screening.
• The subject who understand the requirements of the study and voluntarily consent to participate in the study.
• The subject willing to use birth control measures for the entire study duration and negative urine hCG(Human Chorionic Gonadotrophin) test at screening for women presumed to be of reproductive potential.

Exclusion Criteria

• Known hypersensitivity to any components of the pneumococcal vaccine
• Any confirmed or suspected immunosuppressive or immunodeficient conditions including leukemia, multiple myeloma, lympoma, Hodgkin's disease, etc.
• History of autoimmune disease including multiple sclerosis(MS), lupus, polymyositis, dermatomyositis, Hashmoto's thyroiditis, Sjogren's syndrome, rheumatoid arthritis
• Functional or anatomic asplenia
• Coagulation disorder contraindicating IM(intramuscular) vaccination
• Use of any immunosuppressive therapies within the preceding 3 months including anti-cancer chemotherapies or radiation therapies and medication such as cyclophosphamide, 6-mercaptourine, azathioprine, methotrexate, steroids, cyclosporine A, rapamycin, leflunomide, TNF-α antagonist (For corticosteroids, this will mean prednisone, or equivalent dose of ≥ 15mg/day. Inhaled and topical steroids are allowed.)
• Serious chronic disorders including metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, impaired immune function.
• Any licensed vaccine(not including diphtheria toxoid) administered within the 1 month prior to receipt of study vaccine or is scheduled to receive any other licensed vaccine(not including diphtheria toxoid) within 1 month following receipt of study vaccine.
• Subject has received diphtheria toxoid within 6 months prior to receipt of study vaccine or planned to receive diphtheria toxoid during full period of the study.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SK Chemicals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MYUNGDON OH, MD

Role: STUDY_CHAIR

Seoul National University Hospital

Other Identifiers

NBP606_PCVA_III_2013

Identifier Type: -

Identifier Source: org_study_id