Study Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine

NCT02079207 | Completed Phase 3

• 1 other identifier: NBP606_PCVA_III_2013
• Study Type: interventional
• Target: 767
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Serotype-specific immunoglobulin(IgG) Geometric Mean Concentration (GMC) 1 Month(Day 28) After Vaccination 1

  One Month After Vaccination 1

Study Arms (2)

NBP606

EXPERIMENTAL

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

Biological: NBP606

Prodiax-23

ACTIVE COMPARATOR

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

Biological: Prodiax-23

Interventions

NBP606 BIOLOGICAL

13-valent peumococcal conjugate vaccine(13vPnC)

NBP606

Prodiax-23 BIOLOGICAL

23-valent peumococcal polysaccharide vaccine(23vPS)

Prodiax-23

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SK Chemicals Co., Ltd.: lead

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• MYUNGDON OH, MD

  Seoul National University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: March 5, 2014
• Study Start: December 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: March 1, 2015
• Last Updated: January 27, 2016

Record last verified: 2016-01