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Tritanrix-HepB low thio

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment192

FDA Designations

No designations recorded

Tritanrix-HepB low thio clinical trials

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?

Tritanrix-HepB low thio is an investigational vaccine developed by GSK plc for Haemophilus influenzae type b, an infectious disease. It was studied in a Phase 2 clinical trial in the Philippines. The vaccine is not approved and remains in clinical development.

What is Tritanrix-HepB low thio used for?

Tritanrix-HepB low thio is being studied for Haemophilus influenzae type b, an infectious disease. The Phase 2 trial enrolled healthy volunteers from 6 weeks of age in the Philippines. It is an investigational product and has not been approved for use.

Who makes Tritanrix-HepB low thio?

Tritanrix-HepB low thio is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the Phase 2 trial of the vaccine. The product is an investigational candidate and is not approved.

What phase is Tritanrix-HepB low thio in?

Tritanrix-HepB low thio is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The vaccine is investigational and has not been approved for any indication.

What clinical trials is Tritanrix-HepB low thio in?

Tritanrix-HepB low thio was studied in one completed Phase 2 trial, NCT01061541, titled Immunogenicity, Safety & Reactogenicity of GSK Vaccine Tritanrix-HepB/Hib2.5 Compared to GSK Vaccine Tritanrix-HepB/Hiberix. The randomized, double-blind, active-controlled trial enrolled 192 healthy volunteers in the Philippines.