Study to Evaluate the Safety and Immunogenicity of an Investigational Pneumococcal Vaccine in the Elderly Population

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GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 1

Conditions

Infections, Streptococcal

Treatments

Biological: 11-valent pneumococcal vaccine GSK513026
Biological: Placebo
Biological: 10-valent pneumococcal vaccine GSK513026
Biological: Pneumo 23™

Study type

Interventional

Funder types

Industry

Identifiers

NCT00327665
106072 (Other Identifier)
106068

Details and patient eligibility

About

As the licensed pneumococcal vaccine is not always satisfactory in elderly, new investigational pneumococcal vaccines are evaluated in the healthy elderly population. Note: The study consists of the primary phase (106068): vaccination and follow-up and the extension (106072) of the primary phase: 1 year follow-up. This protocol posting details the procedures of both the primary & extension phase.

Full description

No new subjects will be enrolled in the Extension Phase of the study. All outcome measures at Month 12 will only be evaluated in the subjects in the Belgian site. Upon request, volunteers will receive flu vaccination free of charge. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Enrollment

335 patients

Sex

All

Ages

65 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • A male or female between 65 and 85 years of age at the time of the first vaccination.
  • Written informed consent obtained from the subject.

Exclusion criteria

  • Previous vaccination against Streptococcus pneumoniae.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
  • Acute disease at the time of enrolment.
  • History of documented radiologically confirmed pneumonia within 3 years prior to first vaccination.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
  • Current or history of Parkinson disease, Alzheimer disease, stroke, dementia or any serious neurologic or mental disorders.
  • All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
  • Subjects with documented anaemia or iron-deficiency.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 2 weeks of the first dose of vaccine(s) with the exception of a Flu vaccine which can be administered at least 1 week preceding the first dose of vaccine(s) or 1 month after the first dose of the vaccine(s).
  • 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.
  • Administration of immunoglobulins and/or any blood products within three months preceding the first dose of study vaccine or planned administration during the study period.
  • History of administration of an experimental/licensed vaccine containing MPL or QS21.
  • History of chronic alcohol consumption and/or drug abuse.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

335 participants in 5 patient groups

Group A
Experimental group
Treatment:
Biological: 11-valent pneumococcal vaccine GSK513026
Group B
Experimental group
Treatment:
Biological: 11-valent pneumococcal vaccine GSK513026
Group C
Experimental group
Treatment:
Biological: 11-valent pneumococcal vaccine GSK513026
Group D
Active Comparator group
Treatment:
Biological: Pneumo 23™
Biological: Placebo
Group E
Active Comparator group
Treatment:
Biological: 10-valent pneumococcal vaccine GSK513026

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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