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Pneumococcal vaccine GSK513026

Phase 2

Prophylaxis Invasive Pneumococcal Diseases and Pneumonia | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Oct 30, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment146

FDA Designations

No designations recorded

Clinical trial landscape

Pneumococcal vaccine GSK513026 · 1 trial · 1 indication

Phase 2 1
NCT00307528Safety and Efficacy Study of Investigational Pneumococcal Vaccine in Elderly PopulationProphylaxis Invasive Pneumococcal Diseases and Pneumonia
COMPLETED146 Analytics
PHASE2COMPLETED
Safety and Efficacy Study of Investigational Pneumococcal Vaccine in Elderly Population
Prophylaxis Invasive Pneumococcal Diseases and Pneumonia
NCT00307528146
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Study Endpoints

Primary Endpoints

Occurrence, intensity and relationship 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 30-day follow up period after each vaccine dose.
Occurrence of all serious adverse events (SAE).
During the entire study period.
Anti- PhtD antibody concentration
One month after the first injection
Anti-PhtD antibody concentration.
One month after 2 injections

Secondary Endpoints

Number and percentage of subjects with normal or abnormal values for biochemical assessments and for haematological analysis.
At each scheduled time point (month 0, 1, 3, 12, 24 and 36).
Anti- PhtD antibody concentration.
At 12, 24 and 36 months after the first vaccination.
Anti-PhtD antibody avidity.
At month 0, 1 and 3.
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AACTIVE_COMPARATOR -
Group BEXPERIMENTAL -
Group CEXPERIMENTAL -
Group DEXPERIMENTAL -
Group EEXPERIMENTAL -
Group FEXPERIMENTAL -

Interventions

NameTypeDescription
Pneumococcal vaccine GSK513026BIOLOGICALTwo-dose intramuscular injection. Five different formulations, each administered to one Group
Pneumovax 23™BIOLOGICALSingle dose intramuscular injection.
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Eligibility Criteria

Age Range65 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria * Subjects who the investigator believes will comply with the requirements of the protocol * A male or female ≥ 65 years at the time of the first vaccination. * Written informed consent obtained from the subject. * Free of obvious health problems as established by medical history...

Countries:Belgium
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Frequently asked questions about Pneumococcal vaccine GSK513026

What is Pneumococcal vaccine GSK513026 used for?

Pneumococcal vaccine GSK513026 is an investigational vaccine being developed for prophylaxis of invasive pneumococcal diseases and pneumonia. It is intended for use in the elderly population, specifically adults aged 65 years and older, to help prevent these serious infections.

Who is developing Pneumococcal vaccine GSK513026?

Pneumococcal vaccine GSK513026 is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The vaccine is currently in clinical development for the prevention of invasive pneumococcal diseases and pneumonia.

What phase is Pneumococcal vaccine GSK513026 in?

Pneumococcal vaccine GSK513026 is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the vaccine remains under evaluation for its safety and efficacy in the elderly population.

What clinical trials is Pneumococcal vaccine GSK513026 in?

Pneumococcal vaccine GSK513026 has one completed Phase 2 clinical trial, identified as NCT00307528, titled "Safety and Efficacy Study of Investigational Pneumococcal Vaccine in Elderly Population." The trial enrolled 146 participants aged 65 years and older in Belgium and was an active-controlled study.

Is Pneumococcal vaccine GSK513026 the same as other pneumococcal vaccines?

Pneumococcal vaccine GSK513026 is a distinct investigational vaccine candidate developed by GSK plc. It is not the same as other marketed pneumococcal vaccines, as it is still in clinical development and has not been approved. Its specific formulation and antigen composition are unique to this candidate.