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Tritanrix-HepB low thio

Phase 2

Haemophilus Influenzae Type b | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Sep 9, 2016

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment192

FDA Designations

No designations recorded

Clinical trial landscape

Tritanrix-HepB low thio · 1 trial · 1 indication

Phase 2 1
NCT01061541Immunogenicity, Safety & Reactogenicity of GSK Vaccine Tritanrix™-HepB/Hib2.5 Compared to GSK Vaccine Tritanrix™-HepB/Hiberix™Haemophilus Influenzae Type b
COMPLETED192 Analytics
PHASE2COMPLETED
Immunogenicity, Safety & Reactogenicity of GSK Vaccine Tritanrix™-HepB/Hib2.5 Compared to GSK Vaccine Tritanrix™-HepB/Hiberix™
Haemophilus Influenzae Type bUnlock trial analytics

Study Endpoints

Primary Endpoints

anti-PRP antibody concentration above a protocol defined cut-off value.
One month after the third dose of the primary vaccination course.

Secondary Endpoints

anti-HBs antibody concentration
One month after the third dose of the primary vaccination course
anti-PRP antibody concentration
One month after the third dose of the primary vaccination course
anti-tetanus antibody concentration
One month after the third dose of the primary vaccination course
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTAL -
Group BACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Tritanrix™-HepB low thio /BIOLOGICALOne dose as intramuscular injection at 6, 10 and 14 weeks of age.
Hib 2.5BIOLOGICALOne dose as intramuscular injection at 6, 10 and 14 weeks of age.
Tritanrix™-HepBBIOLOGICALOne dose as intramuscular injection at 6, 10 and 14 weeks of age.
Hiberix™BIOLOGICALOne dose as intramuscular injection at 6, 10 and 14 weeks of age.
Unconjugated Hib vaccine (plain PRP)BIOLOGICALOne dose as intramuscular injection at 10 months of age
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Eligibility Criteria

Age Range6 Weeks to 8 Weeks
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and including, 6 and 8 weeks of age at the time of the first vaccination. * Written inform...

Countries:Philippines
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Frequently asked questions about Tritanrix-HepB low thio

What is Tritanrix-HepB low thio used for?

Tritanrix-HepB low thio is an investigational vaccine being studied for the prevention of Haemophilus Influenzae Type b disease. It is a combination vaccine that includes a low thimerosal formulation. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes Tritanrix-HepB low thio?

Tritanrix-HepB low thio is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in pediatric populations.

What phase is Tritanrix-HepB low thio in?

Tritanrix-HepB low thio is in Phase 2 clinical development. It is an investigational vaccine, meaning it has not been approved for commercial use. The Phase 2 trial has been completed, and the results will inform whether further clinical studies are warranted.

What clinical trials is Tritanrix-HepB low thio in?

Tritanrix-HepB low thio has one completed Phase 2 clinical trial registered as NCT01061541. This study evaluated the immunogenicity, safety, and reactogenicity of the vaccine compared to another GSK vaccine in 192 healthy infants aged 6 weeks and older in the Philippines.

How does Tritanrix-HepB low thio work?

Tritanrix-HepB low thio is a monoclonal antibody vaccine designed to elicit an immune response against Haemophilus Influenzae Type b. By presenting antigens to the immune system, it aims to stimulate the production of protective antibodies that can prevent infection.