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Quadrivalent seasonal influenza vaccine GSK2321138A

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |GSK plc|Last 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

Clinical trial landscape

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
Influenza
NCT0143936012,046
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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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Competitive Landscape -Influenza 14 trials

CompanyTickerTrialsLead PhaseDrugs
Sinovac Biotech Ltd.SVA1PHASE3Participants will receive one dose of vaccine of Sinovac QIV, Vaxigrip QIV
GSK plc Sponsored ADRGSK2PHASE2Flu mRNA, Comparator 1, Comparator 2, Comparator 3
Moderna, Inc.MRNA1PHASE3mRNA-1018-H5
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Traws Pharma, Inc.TRAW2PHASE2TRX-100
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Sanofi SA Sponsored ADRSNY2 - Efluelda Tetra Pre-filled syringe
Pfizer Inc.PFE1 - COVID-19 Vaccine
Abbott LaboratoriesABT1N/AUndisclosed
Grace Therapeutics, Inc.GRCE1N/AUndisclosed
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