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Combined Vi polysaccharide typhoid vaccine and hepatitis A vaccine- Hepatyrix

Phase 3

Hepatitis A | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Sep 9, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment1,034

FDA Designations

No designations recorded

Clinical trial landscape

Combined Vi polysaccharide typhoid vaccine and hepatitis A vaccine- Hepatyrix · 1 trial · 1 indication

Phase 3 1
NCT00197249Comparative Study in Healthy Adults Aged 18-50 Yrs Administered With Hepatyrix or Havrix+Typherix or Tiphim Vi, to Compare Reactogenicity & ImmunogenicityHepatitis A
COMPLETED1,034 Analytics
PHASE3COMPLETED
Comparative Study in Healthy Adults Aged 18-50 Yrs Administered With Hepatyrix or Havrix+Typherix or Tiphim Vi, to Compare Reactogenicity & Immunogenicity
Hepatitis A
NCT001972491,034
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Study Endpoints

Primary Endpoints

Anti-Vi seropositivity rates (i.e., percentage of subjects with anti-Vi antibody titres > or = 150 EL.U/ml) at Month 1 after administration of study vaccine (Comparison of Hepatyrix versus concomitant Havrix+Typherix and Hepatyrix versus Typhim Vi).
Anti-HAV seropositivity rates (i.e., percentage of subjects with anti-HAV antibody titres >or = 15 mIU/ml) at Month 1 after administration of study vaccine, (Comparison of Hepatyrix versus concomitant Havrix+Typherix and Hepatyrix versus Havrix).

Secondary Endpoints

Anti-Vi seropositivity rates at Day 14, Month 6 and Month 7 and GMTs at Day 14, Month 1, Month 6 and Month 7 after administration of study vaccine.
Anti-HAV seropositivity rates at Day 14, Month 6 and Month 7 and GMTs at Day 14, Month 1, Month 6 and Month 7 after administration of study vaccine.
Anti-Vi and anti-HAV seropositivity rates and GMTs at Months 12, 24, 36 after administration of study vaccine.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Combined Vi polysaccharide typhoid vaccine and hepatitis A vaccine- HepatyrixBIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes

Inclusion criteria * Written informed consent will be obtained from the subject prior to entry into the study. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Seronegative for anti-HAV antibodies. * If the subject is fem...

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Competitive Landscape -Hepatitis B 30 trials (matched to "Hepatitis A")

CompanyTickerTrialsLead PhaseDrugs
Gilead Sciences, Inc.GILD3PHASE3Tenofovir DF
Vir Biotechnology, Inc.VIR6PHASE3Tobevibart, Elebsiran
Bausch Health Companies Inc.BHC1PHASE3Larsucosterol
GSK plc Sponsored ADRGSK4PHASE2Daplusiran/Tomligisiran Dose Level 1, Bepirovirsen
Aligos Therapeutics, Inc.ALGS1PHASE2ALG-000184, TDF
Precision BioSciences, Inc.DTIL2PHASE1PBGENE-HBV
Exact Sciences CorporationEXAS1 - Undisclosed
AbbVie, Inc.ABBV1 - Undisclosed
Healthcare Services Group, Inc.HCSG1 - Undisclosed
Plus Therapeutics, Inc.PSTV1N/AUndisclosed
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