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11-valent pneumococcal vaccine GSK513026

Phase 1

Infections, Streptococcal | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: May 8, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment335

FDA Designations

No designations recorded

Clinical trial landscape

11-valent pneumococcal vaccine GSK513026 · 1 trial · 1 indication

Phase 1 1
NCT00327665Study to Evaluate the Safety and Immunogenicity of an Investigational Pneumococcal Vaccine in the Elderly PopulationInfections, Streptococcal
COMPLETED335 Analytics
PHASE1COMPLETED
Study to Evaluate the Safety and Immunogenicity of an Investigational Pneumococcal Vaccine in the Elderly Population
Infections, Streptococcal
NCT00327665335
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Study Endpoints

Primary Endpoints

Occurrence, intensity and relationship to vaccination of any solicited local and general signs and symptoms.
during a 7-day follow up period after each vaccine dose.
Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms
during a 31-day follow up period after each vaccine dose.
Occurrence and relationship to vaccination of all serious adverse events (SAEs).
Throughout the study period.
Post vaccination concentration IgG ≥5 µg/mL and fold increase Post/Pre ≥2 for at least 6 serotypes out of 11
1 month after Dose 2 in Groups A, B, C and 1 month after Dose 1 for Group D
Post vaccination concentration and fold increase Post/Pre ≥2 for at least 6 serotypes out of 11, in Groups A through D.
One month after the first vaccine dose.

Secondary Endpoints

Haematological and biochemical levels within or outside the normal ranges in all groups.
At Months 0, 1, 3, 4 and 12.
IgG antibody concentrations to vaccine pneumococcal serotypes in all groups.
At Months 0, 1, 3, 4 and 12.
Opsonophagocytic activity titres (OPA) against pneumococcal serotypes in all groups.
At Months 0, 1, 3, 4 and 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTAL -
Group BEXPERIMENTAL -
Group CEXPERIMENTAL -
Group DACTIVE_COMPARATOR -
Group EACTIVE_COMPARATOR -

Interventions

NameTypeDescription
11-valent pneumococcal vaccine GSK513026BIOLOGICALTwo-dose intramuscular injection. Each group receiving one of the 3 formulations
Pneumo 23™BIOLOGICALSingle-dose intramuscular injection.
PlaceboBIOLOGICAL1 intramuscular injection.
10-valent pneumococcal vaccine GSK513026BIOLOGICALTwo-dose intramuscular injection
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Eligibility Criteria

Age Range65 Years to 85 Years
SexALL
Healthy VolunteersYes
Study Sites3

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: * Pre...

Countries:BelgiumFinlandSweden
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Frequently asked questions about 11-valent pneumococcal vaccine GSK513026

What is GSK513026 used for?

GSK513026 is an investigational 11-valent pneumococcal vaccine being developed for infections caused by Streptococcus bacteria. It is designed to help protect against streptococcal infections, a type of bacterial infection. The vaccine is currently in clinical development and has not been approved for use.

Who makes GSK513026?

GSK513026 is being developed by GSK plc, a global biopharmaceutical company. GSK plc is listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational pneumococcal vaccine.

What phase is GSK513026 in?

GSK513026 is in Phase 1 of clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the vaccine is still in the early stages of clinical testing to assess its safety and immune response.

What clinical trials is GSK513026 in?

GSK513026 has one completed Phase 1 clinical trial, identified as NCT00327665. This study evaluated the safety and immunogenicity of the investigational pneumococcal vaccine in an elderly population aged 65 years and older. The trial enrolled 335 participants and was conducted in Belgium, Finland, and Sweden.

Is GSK513026 the same as a pneumococcal vaccine?

GSK513026 is an 11-valent pneumococcal vaccine, which means it is designed to target 11 types of pneumococcal bacteria. It is an investigational vaccine being studied for the prevention of streptococcal infections. It is not the same as other pneumococcal vaccines currently on the market, as it is still in clinical development.