Study Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine

Phase 3

Completed

• Conditions: Pneumococcal Infections
• Interventions: Biological: Prodiax-23; Biological: NBP606

• Registration Number: NCT02079207
• Lead Sponsor: SK Chemicals Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-03-03
• Study First Submitted QC: 2014-03-03
• Study First Posted: 2014-03-05
• Primary Completion: 2014-10
• Study Completion: 2015-03
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 767

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prodiax-23	Prodiax-23	Participants aged over 50 years are given a 0.5mL dose of 23-valent pneumococcal polysaccharide vaccine administered on day 0.
NBP606	NBP606	Participants aged over 50 years are given a 0.5mL dose of 13-valent peumococcal conjugate vaccine administered on day 0.

Primary Outcome Measures

Name	Time	Method
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month(Day 28) After Vaccination 1	One month after vaccination 1	For the comparison of OPA GMTs elicited by NBP606 relative to Prodiax-23, the 2-sided 95% CI on the geometric mean ratio(GMR) for each serotype is calculated.

Secondary Outcome Measures

Name	Time	Method
Serotype-specific immunoglobulin(IgG) Geometric Mean Concentration (GMC) 1 Month(Day 28) After Vaccination 1	One Month After Vaccination 1	For the comparison of IgG GMC elicited by NBP606 relative to Prodiax-23, the 2-sided 95% CI on the geometric mean ratio(GMR) for each serotype is calculated.