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11-valent pneumococcal vaccine GSK513026

Phase 1

Infections, Streptococcal | Vaccine | Infectious Disease |GSK plc|Trials Updated: May 8, 2017

11-valent pneumococcal vaccine GSK513026 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since May 2006

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

11-valent pneumococcal vaccine GSK513026 clinical trials

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 the 11-valent pneumococcal vaccine GSK513026?

The 11-valent pneumococcal vaccine GSK513026 is an investigational vaccine developed by GSK plc for streptococcal infections. It is designed to protect against pneumococcal disease and was studied in an elderly population aged 65 years and older. It is a vaccine candidate and remains in clinical development.

What is the 11-valent pneumococcal vaccine GSK513026 used for?

The 11-valent pneumococcal vaccine GSK513026 is being studied for the prevention of streptococcal infections, specifically pneumococcal disease. Its Phase 1 trial enrolled healthy volunteers aged 65 years and older in Belgium, Finland, and Sweden. The vaccine targets the elderly population, a group at higher risk of pneumococcal infection.

Who makes the 11-valent pneumococcal vaccine GSK513026?

GSK plc, which trades under the ticker GSK, is the developer of the 11-valent pneumococcal vaccine GSK513026. The company sponsored the Phase 1 study evaluating the vaccine in an elderly population. GSK513026 is the company's internal designation for this 11-valent pneumococcal vaccine candidate.

What phase is the 11-valent pneumococcal vaccine GSK513026 in?

The 11-valent pneumococcal vaccine GSK513026 is in Phase 1 development. Its single clinical trial, NCT00327665, has been completed. The study was a randomized, double-blind, active-controlled Phase 1 trial that enrolled 335 healthy volunteers aged 65 years and older. The vaccine is investigational and has not been approved.

What clinical trials is the 11-valent pneumococcal vaccine GSK513026 in?

The 11-valent pneumococcal vaccine GSK513026 has been studied in one clinical trial, NCT00327665, titled a study to evaluate the safety and immunogenicity of an investigational pneumococcal vaccine in the elderly population. The Phase 1 trial enrolled 335 participants across Belgium, Finland, and Sweden and is now completed.

Is the 11-valent pneumococcal vaccine GSK513026 FDA approved?

No, the 11-valent pneumococcal vaccine GSK513026 is not approved. It is an investigational vaccine that has completed a single Phase 1 clinical trial, NCT00327665, which assessed safety and immunogenicity in 335 healthy volunteers aged 65 years and older. It remains in clinical development and is not available as a marketed product.

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