Study to Evaluate the Safety and Immunogenicity of an Investigational Pneumococcal Vaccine in the Elderly Population - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00327665

Purpose

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.

Condition	Intervention	Phase
Prophylaxis Invasive Pneumococcal Diseases and Pneumonia	Biological: 11-valent pneumococcal vaccine GSK513026 Biological: Pneumo 23™ Biological: 10-valent pneumococcal vaccine GSK513026 Biological: Placebo	Phase I

MedlinePlus related topics: Pneumonia

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study to Compare the Safety, Reactogenicity & Immunogenicity of GSK Biologicals Pneumococcal Vaccines vs the Licensed 23-Valent Pneumococcal Polysaccharide Vaccine, in Healthy Elderly Subjects

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms [ Time Frame: during a 31-day follow up period after each vaccine dose. ] [ Designated as safety issue: Yes ]
Occurrence and relationship to vaccination of all serious adverse events (SAEs). [ Time Frame: Throughout the study period. ] [ Designated as safety issue: Yes ]
Post vaccination concentration IgG ≥5 µg/mL and fold increase Post/Pre ≥2 for at least 6 serotypes out of 11 [ Time Frame: 1 month after Dose 2 in Groups A, B, C and 1 month after Dose 1 for Group D ] [ Designated as safety issue: No ]
Post vaccination concentration and fold increase Post/Pre ≥2 for at least 6 serotypes out of 11, in Groups A through D. [ Time Frame: One month after the first vaccine dose. ] [ Designated as safety issue: No ]
Occurrence, intensity and relationship to vaccination of any solicited local and general signs and symptoms. [ Time Frame: during a 7-day follow up period after each vaccine dose. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Haematological and biochemical levels within or outside the normal ranges in all groups. [ Time Frame: At Months 0, 1, 3, 4 and 12. ] [ Designated as safety issue: Yes ]
IgG antibody concentrations to vaccine pneumococcal serotypes in all groups. [ Time Frame: At Months 0, 1, 3, 4 and 12. ] [ Designated as safety issue: No ]
Opsonophagocytic activity titres (OPA) against pneumococcal serotypes in all groups. [ Time Frame: At Months 0, 1, 3, 4 and 12 ] [ Designated as safety issue: No ]
Frequencies of IgG PS-specific plasma cells generated by in vitro cultivated memory B-cells for 4 serotypes in all groups, and for 11 serotypes in 10 subjects per group. [ Time Frame: At Months 0, 1, 4 and 12. ] [ Designated as safety issue: No ]
Anti-protein D, anti-tetanus and anti-diphtheria toxoids IgG antibody concentrations in Groups A, B, C and E. [ Time Frame: At Months 0, 1, 3, 4 and 12. ] [ Designated as safety issue: No ]
Frequencies of IgG carrier protein-specific plasma cells generated by in vitro cultivated memory B-cells in a subset of subjects (all subjects minus PS B-cell memory subset) of the Groups A, B, C and E. [ Time Frame: At Months 0, 1, 4 and 12. ] [ Designated as safety issue: No ]
Freq. of CD4+&CD8+ T cells with antigen-specific IL-2 &/or INFy &/or TNFa &/or CD40L secretion/expression to carrier protein as determined by ICS, in a subset of subjects (all subjects minus PS B-cell memory subset) of the Groups A, B, C and E. [ Time Frame: At Months 0, 1, 4 and 12. ] [ Designated as safety issue: No ]

Enrollment:	335
Study Start Date:	May 2006
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group C: Experimental	Biological: 11-valent pneumococcal vaccine GSK513026 Two-dose intramuscular injection. Each group receiving one of the 3 formulations
Group D: Active Comparator	Biological: Pneumo 23™ Single-dose intramuscular injection. Biological: Placebo 1 intramuscular injection.
Group E: Active Comparator	Biological: 10-valent pneumococcal vaccine GSK513026 Two-dose intramuscular injection
Group A: Experimental	Biological: 11-valent pneumococcal vaccine GSK513026 Two-dose intramuscular injection. Each group receiving one of the 3 formulations
Group B: Experimental	Biological: 11-valent pneumococcal vaccine GSK513026 Two-dose intramuscular injection. Each group receiving one of the 3 formulations

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	65 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327665

Locations

Belgium
GSK Investigational Site
Gent, Belgium, 9000
Finland
GSK Investigational Site
Pirkkala, Finland, 33960
Sweden
GSK Investigational Site
UPPSALA, Sweden, SE-751 85

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	106068, 106072
Study First Received:	May 17, 2006
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00327665
Health Authority:	Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by GlaxoSmithKline:

pneumococcal vaccine
elderly subjects
Prophylaxis
invasive pneumococcal diseases
pneumonia

Study placed in the following topic categories:

Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Healthy
Pneumonia

ClinicalTrials.gov processed this record on January 14, 2009