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Pneumococcal vaccine GSK513026

Phase 2

Prophylaxis Invasive Pneumococcal Diseases and Pneumonia | Vaccine | Infectious Disease |GSK plc|Trials Updated: Oct 30, 2019

Pneumococcal vaccine GSK513026 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Mar 2006

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

Pneumococcal vaccine GSK513026 clinical trials

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 PneumoniaUnlock trial analytics

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?

Pneumococcal vaccine GSK513026 is an investigational vaccine developed by GSK plc for prophylaxis of invasive pneumococcal diseases and pneumonia. It is a vaccine candidate that has been studied in a Phase 2 clinical trial in an elderly population. It is not an approved product.

What is Pneumococcal vaccine GSK513026 used for?

Pneumococcal vaccine GSK513026 is being developed for prophylaxis of invasive pneumococcal diseases and pneumonia. The clinical program has focused on elderly adults, with the completed Phase 2 trial enrolling participants aged 65 years and older. It is intended to prevent pneumococcal disease rather than treat it.

Who makes Pneumococcal vaccine GSK513026?

Pneumococcal vaccine GSK513026 is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program for this investigational pneumococcal vaccine candidate.

What phase is Pneumococcal vaccine GSK513026 in?

Pneumococcal vaccine GSK513026 is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are currently listed for this candidate. It is an investigational vaccine and has not been approved for any indication.

What clinical trials is Pneumococcal vaccine GSK513026 in?

Pneumococcal vaccine GSK513026 has been evaluated in one completed Phase 2 trial, NCT00307528, titled Safety and Efficacy Study of Investigational Pneumococcal Vaccine in Elderly Population. The trial enrolled 146 participants in Belgium, was randomized and active controlled, and included adults aged 65 years and older.

How was the Phase 2 trial of Pneumococcal vaccine GSK513026 designed?

The Phase 2 trial NCT00307528 was a randomized, active controlled study of Pneumococcal vaccine GSK513026 in adults aged 65 years and older. It enrolled 146 participants in Belgium, included healthy volunteers, and has been completed. The study assessed safety and efficacy for prophylaxis of invasive pneumococcal diseases and pneumonia.