NCT00307008

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,198

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2006

Completed
Last Updated

April 15, 2013

Status Verified

September 1, 2011

Enrollment Period

1.3 years

First QC Date

March 24, 2006

Last Update Submit

April 11, 2013

Conditions

Streptococcus Pneumoniae Vaccines

Keywords

Prophylaxis Invasive pneumococcal diseases and pneumonia

Outcome Measures

Primary Outcomes (1)

  • Response rate to 11 vaccine serotypes

    One month post vaccination

Secondary Outcomes (7)

  • Anti-polysaccharide total IgG ELISA for 11 vaccine pneumococcal serotypes

    At all time points

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

    At Day 0 and Day 30.

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

    One month post vaccination

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

    Until Month 36.

  • Opsonophagocytic activity response in a subset of subjects.

    At Day 30

  • +2 more secondary outcomes

Study Arms (1)

Group A

EXPERIMENTAL
Biological: Pneumovax 23™

Interventions

Pneumovax 23™BIOLOGICAL

Single dose intramuscular injection

Group A

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

GSK Investigational Site

Eskilstuna, SE-631 88, Sweden

Location

GSK Investigational Site

Jönköping, SE-551 85, Sweden

Location

GSK Investigational Site

Skövde, SE-541 85, Sweden

Location

GSK Investigational Site

Uppsala, SE-751 85, Sweden

Location

GSK Investigational Site

Västerås, SE 721 89, Sweden

Location

MeSH Terms

Conditions

Pneumonia

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2006

First Posted

March 27, 2006

Study Start

October 1, 2003

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

April 15, 2013

Record last verified: 2011-09

Locations

SE(5)