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Pneumococcal vaccine GSK2189241A

Phase 1

Infections, Streptococcal | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: May 10, 2017

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

Clinical trial landscape

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, Streptococcal
NCT00756067168
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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 used for?

Pneumococcal vaccine GSK2189241A is an investigational vaccine being developed for the prevention of infections caused by Streptococcus bacteria. It is intended for use in elderly individuals aged 65 years and older, as evaluated in a clinical trial conducted in Sweden. The vaccine is currently in Phase 1 clinical development.

Who makes Pneumococcal vaccine GSK2189241A?

Pneumococcal vaccine GSK2189241A 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 vaccine.

What phase is Pneumococcal vaccine GSK2189241A in?

Pneumococcal vaccine GSK2189241A is currently in Phase 1 clinical development. It is an investigational vaccine and 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.

What clinical trials is Pneumococcal vaccine GSK2189241A in?

Pneumococcal vaccine GSK2189241A has been evaluated in one completed Phase 1 clinical trial with the identifier NCT00756067. The trial, titled 'Evaluation of Pneumococcal Vaccine Formulations in Elderly,' enrolled 168 participants aged 65 years and older in Sweden. The study was randomized, double-blind, and active-controlled.

Is Pneumococcal vaccine GSK2189241A a monoclonal antibody?

Pneumococcal vaccine GSK2189241A is classified as a monoclonal antibody modality, according to its development profile. However, it is being studied as a vaccine for the prevention of streptococcal infections. The investigational product is administered to healthy elderly volunteers to assess its safety and immune response.