Safety and Efficacy Study of Investigational Pneumococcal Vaccine in Elderly Population
October 28, 2019 updated by: GlaxoSmithKline
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
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.
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 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.
Study Type
Interventional
Enrollment (Actual)
146
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
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Gent, Belgium, 9000
- GSK Investigational Site
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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
Yes
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.
- 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.
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: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Group B
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Two-dose intramuscular injection.
Five different formulations, each administered to one Group
|
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EXPERIMENTAL: Group C
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Two-dose intramuscular injection.
Five different formulations, each administered to one Group
|
|
EXPERIMENTAL: Group D
|
Two-dose intramuscular injection.
Five different formulations, each administered to one Group
|
|
EXPERIMENTAL: Group E
|
Two-dose intramuscular injection.
Five different formulations, each administered to one Group
|
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ACTIVE_COMPARATOR: Group A
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Single dose intramuscular injection.
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EXPERIMENTAL: Group F
|
Two-dose intramuscular injection.
Five different formulations, each administered to one Group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
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During a 7-day follow up period after each vaccine dose.
|
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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.
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During a 30-day follow up period after each vaccine dose.
|
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Occurrence of all serious adverse events (SAE).
Time Frame: During the entire study period.
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During the entire study period.
|
|
Anti- PhtD antibody concentration
Time Frame: One month after the first injection
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One month after the first injection
|
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Anti-PhtD antibody concentration.
Time Frame: One month after 2 injections
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One month after 2 injections
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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).
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At each scheduled time point (month 0, 1, 3, 12, 24 and 36).
|
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Anti- PhtD antibody concentration.
Time Frame: At 12, 24 and 36 months after the first vaccination.
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At 12, 24 and 36 months after the first vaccination.
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Anti-PhtD antibody avidity.
Time Frame: At month 0, 1 and 3.
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At month 0, 1 and 3.
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Evaluation of protection afforded by passive transfer of anti PhtD antibodies sera pooled from all individuals.
Time Frame: At month 0, 1 and 3.
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At month 0, 1 and 3.
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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.
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At month 0, 1, 3, 12.
|
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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.
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At month 0, 1, 3, 12.
|
|
Anti-polysaccharide total IgG concentration in Group A for all vaccine pneumococcal serotypes
Time Frame: At month 0, 1, 12, 24 and 36.
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At month 0, 1, 12, 24 and 36.
|
|
Anti-PS antibody avidity for 5 serotypes in Group A.
Time Frame: At month 0 and 1.
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At month 0 and 1.
|
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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.
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At month 0 and 1.
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Opsonophagocytic activity titres in Group A to all vaccine pneumococcal serotypes
Time Frame: At month 0, 1 and 12.
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At month 0, 1 and 12.
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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.
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At month 0 and month 1.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (ACTUAL)
January 20, 2004
Primary Completion (ACTUAL)
March 30, 2005
Study Completion (ACTUAL)
March 30, 2005
Study Registration Dates
First Submitted
March 6, 2006
First Submitted That Met QC Criteria
March 23, 2006
First Posted (ESTIMATE)
March 28, 2006
Study Record Updates
Last Update Posted (ACTUAL)
October 30, 2019
Last Update Submitted That Met QC Criteria
October 28, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100409
- 100463 (OTHER: GSK)
- 100464 (OTHER: GSK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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 Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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.