Study Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine

SK chemicals

Status and phase

Completed

Phase 3

Conditions

Pneumococcal Infections

Treatments

Biological: Prodiax-23

Biological: NBP606

Study type

Interventional

Funder types

Industry

Identifiers

NCT02079207

NBP606_PCVA_III_2013

Details and patient eligibility

About

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.

Enrollment

767 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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.