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Safety and Efficacy Study of Investigational Pneumococcal Vaccine in Elderly Population

Primary Purpose

Prophylaxis Invasive Pneumococcal Diseases and Pneumonia

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Pneumococcal vaccine GSK513026
Pneumovax 23™
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for 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. Free of obvious health problems as established by medical history and clinical examination before entering into the study. 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. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Use of any anticoagulants. Planned administration/ administration of a vaccine not foreseen by the study protocol within 2 weeks of the first dose of vaccines. Previous vaccination against Streptococcus pneumoniae. Bacterial pneumonia within 3 years prior to 1st vaccination. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Current serious neurologic or mental disorders. Currently smoking > 25 cigarettes per day. Inflammatory processes such as known chronic active infections All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years. History of administration of an experimental vaccine containing MPL or QS21. Acute disease at the time of enrolment. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, at the discretion of the investigator. History of chronic alcohol consumption and/or intravenous drug abuse.

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Group D

Group E

Group F

Arm Description

Outcomes

Primary Outcome Measures

Occurrence, intensity and relationship of any solicited local and general signs and symptoms.
Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms.
Occurrence of all serious adverse events (SAE).
Anti- PhtD antibody concentration
Anti-PhtD antibody concentration.

Secondary Outcome Measures

Number and percentage of subjects with normal or abnormal values for biochemical assessments and for haematological analysis.
Anti- PhtD antibody concentration.
Anti-PhtD antibody avidity.
Evaluation of protection afforded by passive transfer of anti PhtD antibodies sera pooled from all individuals.
Frequency of PhtD specific plasma cells generated by in vitro cultivated memory B-cells, in a subset of subjects.
Frequency of CD4 and/or CD8 T cells that produce cytokines (IL-2, IL-4, IFNg, CD40L and/or GM-CSF, and TNFα), upon PhtD re-stimulation in vitro, to evaluate the T-cell response, in a subset of subjects.
Anti-polysaccharide total IgG concentration in Group A for all vaccine pneumococcal serotypes
Anti-PS antibody avidity for 5 serotypes in Group A.
Deposition of complement components on the surface of different bacterial strains 3 strains (GSK/CDC, OPA, isogenic TIGR4) of 5 serotypes in Group A.
Opsonophagocytic activity titres in Group A to all vaccine pneumococcal serotypes
Frequency of PS-specific plasma cells generated by in vitro cultivated memory B-cells in Group A in a subset of subjects.

Full Information

First Posted
March 6, 2006
Last Updated
October 28, 2019
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00307528
Brief Title
Safety and Efficacy Study of Investigational Pneumococcal Vaccine in Elderly Population
Official Title
A Study to Evaluate the Safety, Reactogenicity & Immunogenicity of the GSK Biologicals Candidate Pneumococcal Vaccine Without or With Adjuvant, Administered at 2 Different Concentrations, in Healthy Elderly Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 20, 2004 (Actual)
Primary Completion Date
March 30, 2005 (Actual)
Study Completion Date
March 30, 2005 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
As the licensed Pneumovax 23™ vaccine is not always satisfactory in elderly subjects, the safety and the immune response of the new investigational pneumococcal protein vaccine is evaluated in healthy elderly population.
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 during the study period (for 3 consecutive years starting from September 2004), 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
Prophylaxis Invasive Pneumococcal Diseases and Pneumonia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Title
Group B
Arm Type
Experimental
Arm Title
Group C
Arm Type
Experimental
Arm Title
Group D
Arm Type
Experimental
Arm Title
Group E
Arm Type
Experimental
Arm Title
Group F
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Pneumococcal vaccine GSK513026
Intervention Description
Two-dose intramuscular injection. Five different formulations, each administered to one Group
Intervention Type
Biological
Intervention Name(s)
Pneumovax 23™
Intervention Description
Single dose intramuscular injection.
Primary Outcome Measure Information:
Title
Occurrence, intensity and relationship of any solicited local and general signs and symptoms.
Time Frame
During a 7-day follow up period after each vaccine dose.
Title
Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms.
Time Frame
During a 30-day follow up period after each vaccine dose.
Title
Occurrence of all serious adverse events (SAE).
Time Frame
During the entire study period.
Title
Anti- PhtD antibody concentration
Time Frame
One month after the first injection
Title
Anti-PhtD antibody concentration.
Time Frame
One month after 2 injections
Secondary Outcome Measure Information:
Title
Number and percentage of subjects with normal or abnormal values for biochemical assessments and for haematological analysis.
Time Frame
At each scheduled time point (month 0, 1, 3, 12, 24 and 36).
Title
Anti- PhtD antibody concentration.
Time Frame
At 12, 24 and 36 months after the first vaccination.
Title
Anti-PhtD antibody avidity.
Time Frame
At month 0, 1 and 3.
Title
Evaluation of protection afforded by passive transfer of anti PhtD antibodies sera pooled from all individuals.
Time Frame
At month 0, 1 and 3.
Title
Frequency of PhtD specific plasma cells generated by in vitro cultivated memory B-cells, in a subset of subjects.
Time Frame
At month 0, 1, 3, 12.
Title
Frequency of CD4 and/or CD8 T cells that produce cytokines (IL-2, IL-4, IFNg, CD40L and/or GM-CSF, and TNFα), upon PhtD re-stimulation in vitro, to evaluate the T-cell response, in a subset of subjects.
Time Frame
At month 0, 1, 3, 12.
Title
Anti-polysaccharide total IgG concentration in Group A for all vaccine pneumococcal serotypes
Time Frame
At month 0, 1, 12, 24 and 36.
Title
Anti-PS antibody avidity for 5 serotypes in Group A.
Time Frame
At month 0 and 1.
Title
Deposition of complement components on the surface of different bacterial strains 3 strains (GSK/CDC, OPA, isogenic TIGR4) of 5 serotypes in Group A.
Time Frame
At month 0 and 1.
Title
Opsonophagocytic activity titres in Group A to all vaccine pneumococcal serotypes
Time Frame
At month 0, 1 and 12.
Title
Frequency of PS-specific plasma cells generated by in vitro cultivated memory B-cells in Group A in a subset of subjects.
Time Frame
At month 0 and month 1.

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. Free of obvious health problems as established by medical history and clinical examination before entering into the study. 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. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Use of any anticoagulants. Planned administration/ administration of a vaccine not foreseen by the study protocol within 2 weeks of the first dose of vaccines. Previous vaccination against Streptococcus pneumoniae. Bacterial pneumonia within 3 years prior to 1st vaccination. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Current serious neurologic or mental disorders. Currently smoking > 25 cigarettes per day. Inflammatory processes such as known chronic active infections All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years. History of administration of an experimental vaccine containing MPL or QS21. Acute disease at the time of enrolment. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, at the discretion of the investigator. History of chronic alcohol consumption and/or intravenous drug abuse.
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
Gent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
https://clinicalstudydatarequest.com/Posting.aspx?ID=1980
Citations:
PubMed Identifier
24176494
Citation
Leroux-Roels I, Devaster JM, Leroux-Roels G, Verlant V, Henckaerts I, Moris P, Hermand P, Van Belle P, Poolman JT, Vandepapeliere P, Horsmans Y. Adjuvant system AS02V enhances humoral and cellular immune responses to pneumococcal protein PhtD vaccine in healthy young and older adults: randomised, controlled trials. Vaccine. 2015 Jan 15;33(4):577-84. doi: 10.1016/j.vaccine.2013.10.052. Epub 2013 Oct 29.
Results Reference
derived

Learn more about this trial

Safety and Efficacy Study of Investigational Pneumococcal Vaccine in Elderly Population

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