Safety and Immune Response Study of an Investigational Pneumococcal Vaccine.

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

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Brief Summary

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The purpose of this study is to evaluate the safety and immunogenicity of two doses of GSK Biologicals' 11 PCV vaccine when given to healthy subjects aged 18 to 40 years .

Detailed Description

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The study is open and subjects will receive two vaccine doses of GSK Biologicals' 11 PCV vaccine. Five blood samples will be taken: prior to and one month after each vaccine dose, and 2 weeks after dose 2.

Conditions

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Prophylactic Pneumococcal Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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pneumococcal vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* healthy male or female between 18 and 40 years of age
* 23-valent pneumococcal polysaccharide vaccine naive adults.

Exclusion Criteria

* Previous vaccination against Streptococcus pneumoniae.
* History of pneumonia within 3 years prior to the first vaccination
* Any confirmed or suspected immunosuppressive or immunodeficient condition
* 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 (Hemoglobin level more than 10% below lower limit of normal)
* History of administration of an experimental/licensed vaccine containing similar adjuvants.
* History of chronic alcohol consumption and/or drug abuse.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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GSK

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

Countries

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Belgium

Other Identifiers

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106962

Identifier Type: -

Identifier Source: org_study_id

NCT00309153