search
Back to results

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

Primary Purpose

Streptococcus Pneumoniae Vaccines

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Pneumovax 23™
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Streptococcus Pneumoniae Vaccines focused on measuring Prophylaxis Invasive pneumococcal diseases and pneumonia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group A

Arm Description

Outcomes

Primary Outcome Measures

Response rate to 11 vaccine serotypes

Secondary Outcome Measures

Anti-polysaccharide total IgG ELISA for 11 vaccine pneumococcal serotypes
Opsonophagocytic activity against 11 vaccine pneumococcal serotypes in a subset of subjects
The rank of subjects from "poorest responder" to "best responder" based on the number of serotypes each subject responds to
Persistence of the immune response in a subset of subjects.
Opsonophagocytic activity response in a subset of subjects.
Occurrence of serious adverse events (SAE).
Occurrence of study related SAEs.

Full Information

First Posted
March 24, 2006
Last Updated
April 11, 2013
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00307008
Brief Title
Study to Evaluate the Response Rate to the Licensed Pneumovax 23™ in Elderly Population.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
February 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Streptococcus Pneumoniae Vaccines
Keywords
Prophylaxis Invasive pneumococcal diseases and pneumonia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Pneumovax 23™
Intervention Description
Single dose intramuscular injection
Primary Outcome Measure Information:
Title
Response rate to 11 vaccine serotypes
Time Frame
One month post vaccination
Secondary Outcome Measure Information:
Title
Anti-polysaccharide total IgG ELISA for 11 vaccine pneumococcal serotypes
Time Frame
At all time points
Title
Opsonophagocytic activity against 11 vaccine pneumococcal serotypes in a subset of subjects
Time Frame
At Day 0 and Day 30.
Title
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
Title
Persistence of the immune response in a subset of subjects.
Time Frame
Until Month 36.
Title
Opsonophagocytic activity response in a subset of subjects.
Time Frame
At Day 30
Title
Occurrence of serious adverse events (SAE).
Time Frame
Up to 1 month after vaccination.
Title
Occurrence of study related SAEs.
Time Frame
Throughout the study period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Eskilstuna
ZIP/Postal Code
SE-631 88
Country
Sweden
Facility Name
GSK Investigational Site
City
Jönköping
ZIP/Postal Code
SE-551 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Skövde
ZIP/Postal Code
SE-541 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Västerås
ZIP/Postal Code
SE 721 89
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs