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Pneumococcal vaccine GSK2830930A

Phase 1

Infections, Streptococcal | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Feb 10, 2021

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment61

FDA Designations

No designations recorded

Clinical trial landscape

Pneumococcal vaccine GSK2830930A · 1 trial · 1 indication

Phase 1 1
NCT01485406Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine 2830930A Administered in ToddlersInfections, Streptococcal
COMPLETED61 Analytics
PHASE1COMPLETED
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine 2830930A Administered in Toddlers
Infections, StreptococcalUnlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence of each grade 3 solicited adverse event with relationship to vaccination
Within 7 days (Day 0-Day 6) after vaccination
Occurrence of grade 3 unsolicited adverse events with relationship to vaccination
Within 31 days (Day 0-Day 30) after vaccination
Occurrence of serious adverse events with relationship to vaccination
During the entire study (from Month 0 up to Month 1)

Secondary Endpoints

Occurrence of each solicited adverse event
Within 7 days (Day 0-Day 6) after vaccination
Occurrence of each unsolicited adverse event
Within 31 days (Day 0-Day 30) after vaccination
Occurrence of serious adverse event
During the entire study (from Month 0 up to Month 1)
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Pn GroupEXPERIMENTALToddlers 12-23 months of age receiving GSK2830930A vaccine.
Control GroupACTIVE_COMPARATORToddlers 12-23 months of age receiving Synflorix.

Interventions

NameTypeDescription
Pneumococcal vaccine GSK2830930ABIOLOGICAL1 dose administered intramuscularly
Synflorix™BIOLOGICAL1 dose administered intramuscularly
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Eligibility Criteria

Age Range12 Months to 23 Months
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol. * A male or female between, and including 12 to 23 months of age at the time of vaccination. * Written informed co...

Countries:Germany
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Frequently asked questions about Pneumococcal vaccine GSK2830930A

What is Pneumococcal vaccine GSK2830930A used for?

Pneumococcal vaccine GSK2830930A is an investigational vaccine being studied for the prevention of streptococcal infections, which are caused by Streptococcus bacteria. It is being developed for use in toddlers, as the clinical trial enrolled children starting at 12 months of age. The vaccine is intended to elicit an immune response against pneumococcal disease.

Who makes Pneumococcal vaccine GSK2830930A?

Pneumococcal vaccine GSK2830930A is being developed by GSK plc, a global biopharma company headquartered in the United Kingdom. GSK trades on the London Stock Exchange and the New York Stock Exchange under the ticker symbol GSK. The company is conducting clinical research to evaluate the vaccine's safety and immunogenicity.

What phase is Pneumococcal vaccine GSK2830930A in?

Pneumococcal vaccine GSK2830930A is in Phase 1 clinical development. The single completed trial was a Phase 1 study, meaning the vaccine is still in early-stage testing. It is investigational and has not been approved by regulatory authorities. Further clinical studies would be needed to assess its safety and efficacy before any potential approval.

What clinical trials is Pneumococcal vaccine GSK2830930A in?

Pneumococcal vaccine GSK2830930A has one completed clinical trial, registered under NCT01485406. This Phase 1 study, titled 'Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine 2830930A Administered in Toddlers,' enrolled 61 participants in Germany. The trial was randomized, double-blind, and active-controlled, and it included healthy toddlers aged 12 months and older.

How does Pneumococcal vaccine GSK2830930A work?

Pneumococcal vaccine GSK2830930A is a monoclonal antibody-based vaccine designed to prevent streptococcal infections. As a vaccine, it is intended to stimulate the immune system to produce a protective response against Streptococcus bacteria. The specific molecular target of this vaccine has not been disclosed in the available information.