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

April 11, 2013 updated by: GlaxoSmithKline

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.

Study Overview

Status

Completed

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

1198

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Single dose intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate to 11 vaccine serotypes
Time Frame: One month post vaccination
One month post vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
Anti-polysaccharide total IgG ELISA for 11 vaccine pneumococcal serotypes
Time Frame: At all time points
At all time points
Opsonophagocytic activity against 11 vaccine pneumococcal serotypes in a subset of subjects
Time Frame: At Day 0 and Day 30.
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
Time Frame: One month post vaccination
One month post vaccination
Persistence of the immune response in a subset of subjects.
Time Frame: Until Month 36.
Until Month 36.
Opsonophagocytic activity response in a subset of subjects.
Time Frame: At Day 30
At Day 30
Occurrence of serious adverse events (SAE).
Time Frame: Up to 1 month after vaccination.
Up to 1 month after vaccination.
Occurrence of study related SAEs.
Time Frame: Throughout the study period.
Throughout the study period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

February 1, 2005

Study Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

March 24, 2006

First Submitted That Met QC Criteria

March 24, 2006

First Posted (Estimate)

March 27, 2006

Study Record Updates

Last Update Posted (Estimate)

April 15, 2013

Last Update Submitted That Met QC Criteria

April 11, 2013

Last Verified

September 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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