Safety and Immune Response Study of an Investigational Pneumococcal Vaccine. - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00327522

Purpose

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 .

Condition	Intervention	Phase
Prophylactic Pneumococcal Diseases	Biological: pneumococcal vaccine	Phase II

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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.

Further study details as provided by GlaxoSmithKline:

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

Estimated Enrollment:	10
Study Start Date:	June 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327522

Locations

Belgium
GSK Investigational Site
Gent, Belgium, 9000

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	106962
Study First Received:	May 17, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00327522
Health Authority:	Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

ClinicalTrials.gov processed this record on January 14, 2009