Study to Evaluate the Safety and Immunogenicity of an Investigational Pneumococcal Vaccine in the Elderly Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

335 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-01

Study Completion Date

2007-01-08

Brief Summary

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As the licensed pneumococcal vaccine is not always satisfactory in elderly, new investigational pneumococcal vaccines are evaluated in the healthy elderly population. Note: The study consists of the primary phase (106068): vaccination and follow-up and the extension (106072) of the primary phase: 1 year follow-up.

This protocol posting details the procedures of both the primary \& extension phase.

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Detailed Description

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No new subjects will be enrolled in the Extension Phase of the study. All outcome measures at Month 12 will only be evaluated in the subjects in the Belgian site.

Upon request, volunteers will receive flu vaccination free of charge. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

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Infections, Streptococcal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A

Group Type EXPERIMENTAL

11-valent pneumococcal vaccine GSK513026

Intervention Type BIOLOGICAL

Two-dose intramuscular injection. Each group receiving one of the 3 formulations

Group B

Group Type EXPERIMENTAL

11-valent pneumococcal vaccine GSK513026

Intervention Type BIOLOGICAL

Two-dose intramuscular injection. Each group receiving one of the 3 formulations

Group C

Group Type EXPERIMENTAL

11-valent pneumococcal vaccine GSK513026

Intervention Type BIOLOGICAL

Two-dose intramuscular injection. Each group receiving one of the 3 formulations

Group D

Group Type ACTIVE_COMPARATOR

Pneumo 23™

Intervention Type BIOLOGICAL

Single-dose intramuscular injection.

Placebo

Intervention Type BIOLOGICAL

1 intramuscular injection.

Group E

Group Type ACTIVE_COMPARATOR

10-valent pneumococcal vaccine GSK513026

Intervention Type BIOLOGICAL

Two-dose intramuscular injection

Interventions

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11-valent pneumococcal vaccine GSK513026

Two-dose intramuscular injection. Each group receiving one of the 3 formulations

Intervention Type BIOLOGICAL

Pneumo 23™

Single-dose intramuscular injection.

Intervention Type BIOLOGICAL

Placebo

1 intramuscular injection.

Intervention Type BIOLOGICAL

10-valent pneumococcal vaccine GSK513026

Two-dose intramuscular injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
* A male or female between 65 and 85 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject.

Exclusion Criteria

* Previous vaccination against Streptococcus pneumoniae.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
* Acute disease at the time of enrolment.
* History of documented radiologically confirmed pneumonia within 3 years prior to first vaccination.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
* Current or history of Parkinson disease, Alzheimer disease, stroke, dementia or any serious neurologic or mental disorders.
* All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
* Subjects with documented anaemia or iron-deficiency.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 2 weeks of the first dose of vaccine(s) with the exception of a Flu vaccine which can be administered at least 1 week preceding the first dose of vaccine(s) or 1 month after the first dose of the vaccine(s).
* 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.
* Administration of immunoglobulins and/or any blood products within three months preceding the first dose of study vaccine or planned administration during the study period.
* History of administration of an experimental/licensed vaccine containing MPL or QS21.
* History of chronic alcohol consumption and/or drug abuse.

Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Ghent, , Belgium

Site Status

GSK Investigational Site

Pirkkala, , Finland

Site Status

GSK Investigational Site

Uppsala, , Sweden

Site Status

Countries

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Belgium Finland Sweden

Study Documents

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