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Quadrivalent seasonal influenza vaccine GSK2321138A

Phase 3

Influenza | Vaccine | Infectious Disease |GSK plc|Trials Updated: Sep 26, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment12,046

FDA Designations

No designations recorded

Quadrivalent seasonal influenza vaccine GSK2321138A clinical trials

Quadrivalent seasonal influenza vaccine GSK2321138A · 1 trial · 1 indication

Phase 3 1
NCT01439360An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in ChildrenInfluenza
COMPLETED12,046 Analytics
PHASE3COMPLETED
An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza.
During the surveillance period (approximately 6 to 8 months)

Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

Number of Subjects With RT-PCR Confirmed Influenza of Any Severity.
During the surveillance period (approximately 6 to 8 months)

Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.

Secondary Endpoints

Number of Subjects With First Occurrence of Lower Respiratory Illness (LRI) With RT-PCR Confirmed Influenza.
At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)
Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Antigenically-matching Influenza Strains.
During the surveillance period (approximately 6 to 8 months)
Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Antigenically-matching Influenza Strains
During the surveillance period (approximately 6 to 8 months)
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
D-QIVEXPERIMENTALSubjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
ControlACTIVE_COMPARATORIn function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).

Interventions

NameTypeDescription
Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138ABIOLOGICALIntramuscular injection
Havrix JuniorBIOLOGICALIntramuscular injection administered to subjects aged 12 months or older
Prevenar 13BIOLOGICALIntramuscular injection administered to subjects less than 12 months of age
Varivax/ProVarivaxBIOLOGICALIntramuscular injection administered to subjects more than 12 months of age
VarilrixBIOLOGICALSubcutaneous injection administered to subjects more than 12 months of age
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Eligibility Criteria

Age Range6 Months to 35 Months
SexALL
Healthy VolunteersYes
Study Sites103

Inclusion Criteria: * Subjects who the investigator believes that their parents/Legally Acceptable Representative (LARs) can and will comply with the requirements of the protocol. * A male or female between, and including, 6 and 35 months of age at the time of first vaccination; children are eligib...

Countries:BangladeshBelgiumCzechiaDominican RepublicHondurasIndiaLebanonPhilippinesPolandSpainThailandTurkey (Türkiye)United Kingdom
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Frequently asked questions about Quadrivalent seasonal influenza vaccine GSK2321138A

What is quadrivalent seasonal influenza vaccine GSK2321138A?

Quadrivalent seasonal influenza vaccine GSK2321138A is an investigational vaccine developed by GSK plc for the prevention of influenza. It is designed to protect against four influenza virus strains, which is what quadrivalent means. It is a vaccine candidate that has been studied in children as young as 6 months old.

What is quadrivalent seasonal influenza vaccine GSK2321138A used for?

Quadrivalent seasonal influenza vaccine GSK2321138A is being developed for the prevention of influenza, a contagious respiratory illness caused by influenza viruses. The clinical program evaluated it in children, with study participants as young as 6 months of age. It is intended for active immunization against seasonal influenza.

Who makes quadrivalent seasonal influenza vaccine GSK2321138A?

Quadrivalent seasonal influenza vaccine GSK2321138A is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals, the company's vaccines business, sponsored the clinical study of this candidate influenza vaccine. GSK2321138A is the internal GSK code for the candidate.

What phase is quadrivalent seasonal influenza vaccine GSK2321138A in?

Quadrivalent seasonal influenza vaccine GSK2321138A has been studied in a Phase 3 clinical trial. It is an investigational vaccine candidate and is not described as approved. The Phase 3 study has been completed, and no trials of this candidate are currently listed as active.

What clinical trials is quadrivalent seasonal influenza vaccine GSK2321138A in?

Quadrivalent seasonal influenza vaccine GSK2321138A was evaluated in the Phase 3 trial NCT01439360, titled An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children. The completed study enrolled 12,046 participants across 13 countries, including Bangladesh, Belgium, Czechia, the Dominican Republic, Honduras, India, Lebanon, the Philippines, Poland, Spain, Thailand, Turkey and the United Kingdom.

Is quadrivalent seasonal influenza vaccine GSK2321138A the same as Flu D-QIV GSK2321138A?

Yes. Quadrivalent seasonal influenza vaccine GSK2321138A is also known as quadrivalent seasonal influenza vaccine (Flu D-QIV) GSK2321138A. Flu D-QIV is a shorthand label for the same GSK candidate vaccine, and GSK2321138A is the company's internal identifier. Searches for either name refer to the same investigational influenza vaccine.