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Pneumococcal vaccine GSK2189241A

Phase 1

Infections, Streptococcal | Vaccine | Infectious Disease |GSK plc|Trials Updated: May 10, 2017

Pneumococcal vaccine GSK2189241A development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment168

FDA Designations

No designations recorded

Pneumococcal vaccine GSK2189241A clinical trials

Pneumococcal vaccine GSK2189241A · 1 trial · 1 indication

Phase 1 1
NCT00756067Evaluation of Pneumococcal Vaccine Formulations in ElderlyInfections, Streptococcal
COMPLETED168 Analytics
PHASE1COMPLETED
Evaluation of Pneumococcal Vaccine Formulations in Elderly
Infections, StreptococcalUnlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence of any vaccine related and grade 3 solicited local and general adverse events
During a 7-day follow up period after each vaccine dose
Occurrence of any vaccine related and grade 3 unsolicited adverse events
During a 31-day follow up period after each vaccine dose
Occurrence of any vaccine related serious adverse events (SAE)
From dose 1 to study conclusion
Occurrence of any grade 3 laboratory abnormalities
At 1 and 7 days after each vaccine dose

Secondary Endpoints

Occurrence of any solicited local and general adverse events
During a 7-day follow up period after each vaccine dose
Occurrence of any unsolicited adverse events
During a 31-day follow up period after each vaccine dose
Occurrence of any laboratory abnormalities
At 1 and 7 days after each vaccine dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Formulation 1EXPERIMENTAL -
Formulation 2EXPERIMENTAL -
Formulation 3EXPERIMENTAL -
Formulation 4EXPERIMENTAL -
Formulation 5EXPERIMENTAL -
Formulation 6EXPERIMENTAL -
23 valent pneumococcal vaccineACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Pneumococcal vaccine GSK2189241ABIOLOGICALTwo doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.
Pneumo 23™BIOLOGICALOne dose of 0.5 ml will be administered intramuscularly at Month 0, and a placebo dose to keep the blinding at Month 2.
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Eligibility Criteria

Age Range65 Years to 85 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study. * Male or female subjects between, and including, 65 and 85 years old at the time of the first vaccination, in relatively stable health. * Written informed...

Countries:Sweden
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Frequently asked questions about Pneumococcal vaccine GSK2189241A

What is pneumococcal vaccine GSK2189241A?

Pneumococcal vaccine GSK2189241A is an investigational vaccine developed by GSK plc for infections caused by streptococcal bacteria, specifically pneumococcal disease. It is a Phase 1 candidate and has not been approved for use. It was studied in a single completed clinical trial in elderly healthy volunteers.

What is pneumococcal vaccine GSK2189241A used for?

Pneumococcal vaccine GSK2189241A is being developed for the prevention of streptococcal infections, the bacterial infections that include pneumococcal disease. Its only recorded clinical study enrolled healthy volunteers aged 65 years and older, so the investigated use is prevention in an elderly population.

Who makes pneumococcal vaccine GSK2189241A?

Pneumococcal vaccine GSK2189241A is developed by GSK plc, which trades under the ticker GSK. The vaccine candidate is part of the company's infectious disease pipeline and is identified by the internal code GSK2189241A.

What phase is pneumococcal vaccine GSK2189241A in?

Pneumococcal vaccine GSK2189241A is in Phase 1 clinical development. It is an investigational vaccine and is not approved for any indication. One Phase 1 trial has been completed, and no trials are currently listed as active.

What clinical trials is pneumococcal vaccine GSK2189241A in?

Pneumococcal vaccine GSK2189241A has been studied in one completed Phase 1 trial, NCT00756067, titled Evaluation of Pneumococcal Vaccine Formulations in Elderly. The trial enrolled 168 healthy volunteers aged 65 years and older in Sweden and used a randomized, double-blind, active-controlled design.