Back to resultsSafety and Immune Response Study of an Investigational Pneumococcal Vaccine.
Primary Purpose
Prophylactic Pneumococcal Diseases
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
pneumococcal vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Prophylactic Pneumococcal Diseases
Eligibility Criteria
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.
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Occurrence of solicited local & general symptoms (Day 0-7) and unsolicited symptoms (Day 0-30) after vaccination. Occurrence of serious adverse events during the entire study;
Frequencies of IgG PS-specific plasma cells (by B-cell ELISPOT) for 11 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F) prior to & 1 month post dose 1, 2 weeks & 1 month post dose 2
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00327522
Brief Title
Safety and Immune Response Study of an Investigational Pneumococcal Vaccine.
Official Title
An Open, Phase I/II Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' 11PCV Vaccine Given as a 2-Dose Vaccination in Adults Aged 18-40 Years Old.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prophylactic Pneumococcal Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
pneumococcal vaccine
Primary Outcome Measure Information:
Title
Occurrence of solicited local & general symptoms (Day 0-7) and unsolicited symptoms (Day 0-30) after vaccination. Occurrence of serious adverse events during the entire study;
Title
Frequencies of IgG PS-specific plasma cells (by B-cell ELISPOT) for 11 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F) prior to & 1 month post dose 1, 2 weeks & 1 month post dose 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
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
Learn more about this trial
Safety and Immune Response Study of an Investigational Pneumococcal Vaccine.
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