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Pneumococcal vaccine GSK2830930A

Phase 1

Infections, Streptococcal | Vaccine | Infectious Disease |GSK plc|Trials Updated: Feb 10, 2021

Pneumococcal vaccine GSK2830930A development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Dec 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment61

FDA Designations

No designations recorded

Pneumococcal vaccine GSK2830930A clinical trials

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?

Pneumococcal vaccine GSK2830930A is an investigational vaccine developed by GSK plc for streptococcal infections. It is a Phase 1 candidate studied in toddlers, and it has been evaluated in a single completed clinical trial. It is not an approved product.

What is pneumococcal vaccine GSK2830930A used for?

Pneumococcal vaccine GSK2830930A is being studied for the prevention of streptococcal infections. Its only recorded clinical trial enrolled healthy toddlers aged 12 months and older in Germany. The vaccine remains investigational and is not approved for use.

Who makes pneumococcal vaccine GSK2830930A?

Pneumococcal vaccine GSK2830930A is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals conducted the clinical work on the candidate. No other developer or partner is associated with the asset.

What phase is pneumococcal vaccine GSK2830930A in?

Pneumococcal vaccine GSK2830930A is in Phase 1 development. Its single trial, NCT01485406, has been completed, and no trials are currently active. The vaccine is investigational and has not been approved by the FDA or any other regulator.

What clinical trials is pneumococcal vaccine GSK2830930A in?

Pneumococcal vaccine GSK2830930A has been studied in one clinical trial, NCT01485406, titled a safety and immunogenicity study of GSK Biologicals' pneumococcal vaccine 2830930A administered in toddlers. The Phase 1 trial was completed, enrolled 61 participants in Germany, and used a randomized, double-blind, active-controlled design.