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Safety and Efficacy Study of Investigational Pneumococcal Vaccine in Elderly Population

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ClinicalTrials.gov Identifier: NCT00307528
Recruitment Status : Completed
First Posted : March 28, 2006
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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 or disease Intervention/treatment Phase
Prophylaxis Invasive Pneumococcal Diseases and Pneumonia Biological: Pneumococcal vaccine GSK513026 Biological: Pneumovax 23™ Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : January 2004
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. Occurrence of all serious adverse events (SAE). [ Time Frame: During the entire study period. ]
  4. Anti- PhtD antibody concentration [ Time Frame: One month after the first injection ]
  5. Anti-PhtD antibody concentration. [ Time Frame: One month after 2 injections ]

Secondary Outcome Measures :
  1. 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). ]
  2. Anti- PhtD antibody concentration. [ Time Frame: At 12, 24 and 36 months after the first vaccination. ]
  3. Anti-PhtD antibody avidity. [ Time Frame: At month 0, 1 and 3. ]
  4. Evaluation of protection afforded by passive transfer of anti PhtD antibodies sera pooled from all individuals. [ Time Frame: At month 0, 1 and 3. ]
  5. 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. ]
  6. 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. ]
  7. Anti-polysaccharide total IgG concentration in Group A for all vaccine pneumococcal serotypes [ Time Frame: At month 0, 1, 12, 24 and 36. ]
  8. Anti-PS antibody avidity for 5 serotypes in Group A. [ Time Frame: At month 0 and 1. ]
  9. 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. ]
  10. Opsonophagocytic activity titres in Group A to all vaccine pneumococcal serotypes [ Time Frame: At month 0, 1 and 12. ]
  11. 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. ]


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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00307528


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00307528     History of Changes
Other Study ID Numbers: 100409
100463 ( Other Identifier: GSK )
100464 ( Other Identifier: GSK )
First Posted: March 28, 2006    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Pneumonia
Pneumococcal Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs