Safety and Efficacy Study of Investigational Pneumococcal Vaccine in Elderly Population

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00307528
First received: March 6, 2006
Last updated: October 27, 2011
Last verified: October 2011
  Purpose

As the licensed Pneumovax 23™ vaccine is not always satisfactory in elderly subjects, the safety and the immune response of the new investigational pneumococcal protein vaccine is evaluated in healthy elderly population.


Condition Intervention Phase
Prophylaxis Invasive Pneumococcal Diseases and Pneumonia
Biological: Pneumococcal vaccine GSK513026
Biological: Pneumovax 23™
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Safety, Reactogenicity & Immunogenicity of the GSK Biologicals Candidate Pneumococcal Vaccine Without or With Adjuvant, Administered at 2 Different Concentrations, in Healthy Elderly Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence, intensity and relationship of any solicited local and general signs and symptoms. [ Time Frame: During a 7-day follow up period after each vaccine dose. ] [ Designated as safety issue: No ]
  • Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms. [ Time Frame: During a 30-day follow up period after each vaccine dose. ] [ Designated as safety issue: No ]
  • Occurrence of all serious adverse events (SAE). [ Time Frame: During the entire study period. ] [ Designated as safety issue: No ]
  • Anti- PhtD antibody concentration [ Time Frame: One month after the first injection ] [ Designated as safety issue: No ]
  • Anti-PhtD antibody concentration. [ Time Frame: One month after 2 injections ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number and percentage of subjects with normal or abnormal values for biochemical assessments and for haematological analysis. [ Time Frame: At each scheduled time point (month 0, 1, 3, 12, 24 and 36). ] [ Designated as safety issue: No ]
  • Anti- PhtD antibody concentration. [ Time Frame: At 12, 24 and 36 months after the first vaccination. ] [ Designated as safety issue: No ]
  • Anti-PhtD antibody avidity. [ Time Frame: At month 0, 1 and 3. ] [ Designated as safety issue: No ]
  • Evaluation of protection afforded by passive transfer of anti PhtD antibodies sera pooled from all individuals. [ Time Frame: At month 0, 1 and 3. ] [ Designated as safety issue: No ]
  • Frequency of PhtD specific plasma cells generated by in vitro cultivated memory B-cells, in a subset of subjects. [ Time Frame: At month 0, 1, 3, 12. ] [ Designated as safety issue: No ]
  • Frequency of CD4 and/or CD8 T cells that produce cytokines (IL-2, IL-4, IFNg, CD40L and/or GM-CSF, and TNFα), upon PhtD re-stimulation in vitro, to evaluate the T-cell response, in a subset of subjects. [ Time Frame: At month 0, 1, 3, 12. ] [ Designated as safety issue: No ]
  • Anti-polysaccharide total IgG concentration in Group A for all vaccine pneumococcal serotypes [ Time Frame: At month 0, 1, 12, 24 and 36. ] [ Designated as safety issue: No ]
  • Anti-PS antibody avidity for 5 serotypes in Group A. [ Time Frame: At month 0 and 1. ] [ Designated as safety issue: No ]
  • Deposition of complement components on the surface of different bacterial strains 3 strains (GSK/CDC, OPA, isogenic TIGR4) of 5 serotypes in Group A. [ Time Frame: At month 0 and 1. ] [ Designated as safety issue: No ]
  • Opsonophagocytic activity titres in Group A to all vaccine pneumococcal serotypes [ Time Frame: At month 0, 1 and 12. ] [ Designated as safety issue: No ]
  • Frequency of PS-specific plasma cells generated by in vitro cultivated memory B-cells in Group A in a subset of subjects. [ Time Frame: At month 0 and month 1. ] [ Designated as safety issue: No ]

Enrollment: 146
Study Start Date: January 2004
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A Biological: Pneumovax 23™
Single dose intramuscular injection.
Experimental: Group B Biological: Pneumococcal vaccine GSK513026
Two-dose intramuscular injection. Five different formulations, each administered to one Group
Experimental: Group C Biological: Pneumococcal vaccine GSK513026
Two-dose intramuscular injection. Five different formulations, each administered to one Group
Experimental: Group D Biological: Pneumococcal vaccine GSK513026
Two-dose intramuscular injection. Five different formulations, each administered to one Group
Experimental: Group E Biological: Pneumococcal vaccine GSK513026
Two-dose intramuscular injection. Five different formulations, each administered to one Group
Experimental: Group F Biological: Pneumococcal vaccine GSK513026
Two-dose intramuscular injection. Five different formulations, each administered to one Group

Detailed Description:

Since influenza vaccination is recommended in the age range of the study population, Fluarix™ (GlaxoSmithKline Biologicals) vaccine will be offered free of charge during the study period (for 3 consecutive years starting from September 2004), to be used by Investigators according to national vaccination schedule/practice.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  • Subjects who the investigator believes will comply with the requirements of the protocol
  • A male or female ≥ 65 years at the time of the first vaccination.
  • Written informed consent obtained from the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion criteria

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Use of any anticoagulants.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 2 weeks of the first dose of vaccines.
  • Previous vaccination against Streptococcus pneumoniae.
  • Bacterial pneumonia within 3 years prior to 1st vaccination.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Current serious neurologic or mental disorders.
  • Currently smoking > 25 cigarettes per day.
  • Inflammatory processes such as known chronic active infections
  • All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
  • History of administration of an experimental vaccine containing MPL or QS21.
  • Acute disease at the time of enrolment.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, at the discretion of the investigator.
  • History of chronic alcohol consumption and/or intravenous drug abuse.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307528

Locations
Belgium
GSK Investigational Site
Gent, Belgium, 9000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00307528     History of Changes
Other Study ID Numbers: 100409, 100463, 100464
Study First Received: March 6, 2006
Last Updated: October 27, 2011
Health Authority: Belgium: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014