Study Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine

Pneumococcal Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079207
• Other study ID #: NBP606_PCVA_III_2013
• Status: Completed
• Phase: Phase 3
• First received: March 3, 2014
• Last updated: January 26, 2016
• Start date: December 2013
• Est. completion date: March 2015

Study information

• Verified date: January 2016
• Source: SK Chemicals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 767
• Est. completion date: March 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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-a 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumococcal Infections

Intervention

Biological:
• NBP606
13-valent peumococcal conjugate vaccine(13vPnC)
• Prodiax-23
23-valent peumococcal polysaccharide vaccine(23vPS)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co.,Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month(Day 28) 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.	One month after vaccination 1	No
Secondary	Serotype-specific immunoglobulin(IgG) Geometric Mean Concentration (GMC) 1 Month(Day 28) 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.	One Month After Vaccination 1	No