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Combined Vi polysaccharide typhoid vaccine and hepatitis A vaccine- Hepatyrix

Phase 3

Hepatitis A | Vaccine | Infectious Disease |GSK plc|Trials Updated: Sep 9, 2016

Combined Vi polysaccharide typhoid vaccine and hepatitis A vaccine- Hepatyrix development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Sep 2005

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

Combined Vi polysaccharide typhoid vaccine and hepatitis A vaccine- Hepatyrix clinical trials

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 AUnlock trial analytics

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 40 trials (matched to "Hepatitis A")

Frequently asked questions about Combined Vi polysaccharide typhoid vaccine and hepatitis A vaccine- Hepatyrix

What is Hepatyrix used for?

Hepatyrix is a combined vaccine developed by GSK plc for protection against hepatitis A and typhoid fever. It combines a Vi polysaccharide typhoid vaccine with a hepatitis A vaccine in a single formulation. It is intended for use in adults aged 18 to 50 years, particularly those at risk of both infections.

Who makes Hepatyrix?

Hepatyrix is developed and manufactured by GSK plc, which trades under the ticker GSK. GSK is a global pharmaceutical company with a portfolio of vaccines and medicines.

What phase is Hepatyrix in?

Hepatyrix has been evaluated in Phase 3 clinical development. One Phase 3 trial has been completed, and no active trials are currently listed. The vaccine is not described as approved in the available information, so it remains an investigational product.

What clinical trials is Hepatyrix in?

Hepatyrix has been studied in a completed Phase 3 trial, NCT00197249. This trial enrolled 1,034 healthy adults aged 18 to 50 years and compared Hepatyrix with Havrix plus Typherix or Tiphim Vi, assessing reactogenicity and immunogenicity. The trial was randomized but not double-blind and used an uncontrolled design.

Is Hepatyrix the same as Havrix or Typherix?

No, Hepatyrix is a combined vaccine that includes both hepatitis A and typhoid Vi polysaccharide components. Havrix is a separate hepatitis A vaccine, and Typherix is a separate typhoid Vi polysaccharide vaccine. Hepatyrix was compared against these separate vaccines in its clinical trial.