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Safety and Immunogenicity of GSK692342 TB Vaccine Formulations
NCT00397943Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2006
- Primary completion
- Dec 2009
- Countries
- 1
- Sponsor
- GSK
- Modality
- Split/Subunit Vaccines, Peptide-based Cancer Vaccines, Fc-Fusion Proteins
- Drugs
- M72 + AS01E
- Conditions
- Tuberculosis (TB)
01
Overview
Phase 2, randomised, single-blind trial of M72 + AS01E in Tuberculosis (TB) (5 arms), sponsored by GSK. Primary endpoints: Number of Subjects With Any and Grade 3 Solicited Local Symptoms, Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms and 5 more. Started Nov 2006; status: completed.
02
Design
5 arms- Study design
- RandomizedSingle-blind
M72/AS01B Group
GSK692342 (M72) + AS01B adjuvant
M72/AS02A Group
GSK692342 (M72) + AS02A adjuvant
Mtb72F/AS02A Group
Mtb72F antigen + AS02A adjuvant (Comparator)
Non-adjuvanted Group
M. tuberculosis antigen alone (Comparator)
Control Group
Adjuvant system alone (Control)
03
Who it enrols
Healthy adults aged 18-50 with negative PPD skin test and no history of TB or exposure to TB.
04
Endpoints
Primary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Number of Subjects With Serious Adverse Events (SAEs)
Number of Subjects With Normal or Abnormal Haematological and Biochemical Levels
Secondary
Antibody Concentrations Against Mycobacterium Tuberculosis Fusion Proteins M72 and Mtb72F
Frequency of M72 Specific CD4+/CD8+ T-cells Expressing Cytokines
Concentrations of IFN-γ Produced in Serum Samples
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