Safety and Immune Response Study of an Investigational Pneumococcal Vaccine.

Tracking Information
First Submitted Date ICMJE	May 17, 2006
First Posted Date ICMJE	May 18, 2006
Last Update Posted Date	October 13, 2008
Study Start Date ICMJE	June 2006
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: May 17, 2006)	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
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00327522 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety and Immune Response Study of an Investigational Pneumococcal Vaccine.
Official Title ICMJE	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.
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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	Prophylactic Pneumococcal Diseases
Intervention ICMJE	Biological: pneumococcal vaccine
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: May 17, 2006)	10
Original Enrollment ICMJE	Same as current
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 40 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Belgium
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00327522
Other Study ID Numbers ICMJE	106962
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Study Director, GSK
Study Sponsor ICMJE	GlaxoSmithKline
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account	GlaxoSmithKline
Verification Date	October 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP