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Completed

NCT Number: NCT00307008

Study to Evaluate the Response Rate to the Licensed Pneumovax 23™ in Elderly Population.

Streptococcus pneumoniae are bacteria which normally live in the upper respiratory tract of humans. However, these bacteria can also cause severe infectious diseases such as pneumonia, septicemia and meningitis. Elderly subjects are especially vulnerable to these infections, and the diseases can result in death. The currently available licensed Streptococcus pneumoniae vaccine is recommended for prevention of pneumococcal diseases in individuals over the age of 65. However, the antibody level elicited by this vaccine, is not always satisfactory in elderly people. To overcome the problem, GlaxoSmithKline Biologicals is currently developing candidate vaccines that are hoped to work better than the currently available vaccines. As a first step in this development, the present study is being conducted in order to evaluate the immune response to the currently marketed vaccine.

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Key information

Conditions

Streptococcus Pneumoniae Vaccines Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Eskilstuna, Sweden

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About this study

Since influenza vaccination is recommended in the age range of the study population, Fluarix™ (GlaxoSmithKline Biologicals) vaccine will be offered free of charge for the study period (3 consecutive years), 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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.
  • Previous vaccination against Streptococcus pneumoniae.
  • History of administration of an experimental vaccine containing MPL or QS21.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Planned administration of a vaccine not foreseen by the study protocol within 2 weeks before and after first dose of vaccines, excluding influenza vaccine which can be administered at any time, including co-administration with Pneumovax23™.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • Current serious neurologic or mental disorders.
  • Inflammatory processes such as known chronic active infections (e.g.Hep B, C).
  • All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
  • Acute disease at the time of enrolment.
  • Chronic disease that might preclude participation to the whole study.

Treatment and study plan

Pneumovax 23™

Biological

Single dose intramuscular injection

Primary outcomes

  1. Response rate to 11 vaccine serotypes

    Time frame: One month post vaccination

Secondary outcomes

  1. Anti-polysaccharide total IgG ELISA for 11 vaccine pneumococcal serotypes

    Time frame: At all time points

  2. Opsonophagocytic activity against 11 vaccine pneumococcal serotypes in a subset of subjects

    Time frame: At Day 0 and Day 30.

  3. The rank of subjects from "poorest responder" to "best responder" based on the number of serotypes each subject responds to

    Time frame: One month post vaccination

  4. Persistence of the immune response in a subset of subjects.

    Time frame: Until Month 36.

  5. Opsonophagocytic activity response in a subset of subjects.

    Time frame: At Day 30

  6. Occurrence of serious adverse events (SAE).

    Time frame: Up to 1 month after vaccination.

  7. Occurrence of study related SAEs.

    Time frame: Throughout the study period.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Open, Phase II Study to Evaluate the Response Rate to the Licensed Single-Dose Polysaccharide Pneumococcal Vaccine Pneumovax 23™ (MSD Aventis Pasteur) in Elderly Population.

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Mar 27, 2006
Registry last updated
Apr 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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