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CompletedNCT00307008Updated Apr 15, 2013

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

A Phase 2 interventional study of Pneumovax 23™ in Streptococcus Pneumoniae Vaccines, sponsored by GlaxoSmithKline. Completed at 5 sites in Sweden. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-15.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
1,198
Allocation
Non-randomized
Ages
65 Years and older
Sex
All
01

Study 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. 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

02

Conditions studied

  • Streptococcus Pneumoniae Vaccines

Keywords

  • Prophylaxis Invasive pneumococcal diseases and pneumonia
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 1,198 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
1,198 participants (actual)

Study arms

  • Experimental
    Group A

    Biological: Pneumovax 23™

Interventions

  • BiologicalPneumovax 23™

    Single dose intramuscular injection

06

What researchers measure

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.

07

Study locations

5 sites
  • GSK Investigational Site
    Eskilstuna, SE-631 88, Sweden
  • GSK Investigational Site
    Jönköping, SE-551 85, Sweden
  • GSK Investigational Site
    Skövde, SE-541 85, Sweden
  • GSK Investigational Site
    Uppsala, SE-751 85, Sweden
  • GSK Investigational Site
    Västerås, SE 721 89, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00307008
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Mar 27, 2006
Start date
Oct 2003
Primary completion
Feb 2005
Completion
Feb 2005
Last update
Apr 15, 2013

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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