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Streptococcus Pneumoniae VaccinesPhase 2NCT00307008

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

A Phase 2 study testing Pneumovax 23™ in people with Streptococcus Pneumoniae Vaccines, run by GlaxoSmithKline at 5 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Streptococcus Pneumoniae Vaccines
What is being tested?
Pneumovax 23™
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,198 participants
Where
5 sitesSweden
Study dates
Oct 2003to Feb 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Sweden5 sites

  • GSK Investigational Site

    Eskilstuna, SE-631 88

  • GSK Investigational Site

    Jönköping, SE-551 85

  • GSK Investigational Site

    Skövde, SE-541 85

  • GSK Investigational Site

    Uppsala, SE-751 85

  • GSK Investigational Site

    Västerås, SE 721 89

Other trials in Sweden

About this study

Official 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.

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.

Read the 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 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

Being tested
Pneumovax 23™
Keywords
Prophylaxis Invasive pneumococcal diseases and pneumonia
Medical subject headings
Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pneumovax 23™Biological

    Single dose intramuscular injection

Study groups in NCT00307008
Study groupRoleWhat they receive
Group AExperimentalNot described
Receives: Biological: Pneumovax 23™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate to 11 vaccine serotypes

    Measured: One month post vaccination

Secondary outcomes (7)

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

    Measured: At all time points

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

    Measured: 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

    Measured: One month post vaccination

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

    Measured: Until Month 36.

  5. Opsonophagocytic activity response in a subset of subjects.

    Measured: At Day 30

  6. Occurrence of serious adverse events (SAE).

    Measured: Up to 1 month after vaccination.

  7. Occurrence of study related SAEs.

    Measured: Throughout the study period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2006 (estimated)
  2. Study startOct 2003
  3. Primary completionFeb 2005
  4. Study completionFeb 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,198 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00307008
Sponsor's protocol ID
513026/004
Other IDs
100421, 100436
Status last verified
Sep 2011
First submitted
24 Mar 2006
Last updated
15 Apr 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pneumovax 23™ in people with Streptococcus Pneumoniae Vaccines, run by GlaxoSmithKline at 5 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate to 11 vaccine serotypes (time frame: One month post vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00307008.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2013.

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