Clinical trial NCT02079207: Study Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine
Official title: Multi-center, Randomized, Double Blinded, Phase III Trial to Assess the Immunogenicity and Safety of NBP606 in Adults 50 Years of Age and Older Who Are naïve to Pneumococcal Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infections
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-03-05
Enrollment: 767
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month(Day 28) After Vaccination 1
timeFrame: One month after vaccination 1
Secondary outcomes:
measure: Serotype-specific immunoglobulin(IgG) Geometric Mean Concentration (GMC) 1 Month(Day 28) After Vaccination 1
timeFrame: One Month After Vaccination 1
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: MYUNGDON OH, MD
role: STUDY_CHAIR
References: