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Hib-MenAC mixed with Tritanrix-HepB

Phase 3

Tetanus | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Oct 7, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment800

FDA Designations

No designations recorded

Clinical trial landscape

Hib-MenAC mixed with Tritanrix-HepB · 1 trial · 5 indications

Phase 3 1
NCT00197275Lot-to-lot Consistency of Tritanrix™-HepB/Hib-MenAC & Its Non-inferiority vs Tritanrix™-HepB/Hiberix™ in InfantsTetanus
COMPLETED800 Analytics
PHASE3COMPLETED
Lot-to-lot Consistency of Tritanrix™-HepB/Hib-MenAC & Its Non-inferiority vs Tritanrix™-HepB/Hiberix™ in Infants
Tetanus
NCT00197275800
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Study Endpoints

Primary Endpoints

Immune response 1 month post dose 3 (SBA-MenA/C titers ≥ 1:8, anti-PRP ≥ 0.15 µg/ml, -diphtheria ≥ 0.1 IU/ml (ELISA) OR ≥ 0.016 IU/ml (Vero-cell test), -tetanus ≥ 0.1 IU/ml, -HB concentration ≥ 10 mIU/ml, vaccine response to Bordetella pertus

Secondary Endpoints

Antibody conc or titer, seroprot, seropos and/or vacc response to all antigens administered (Prior to dose 1, 2 m after dose 2 & 1m after dose 3). After each dose: Solicited (d 0-3, local/general), unsolicited (d 0-30) symptoms. During whole study: SAEs
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Hib-MenAC mixed with Tritanrix™-HepBBIOLOGICAL -
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Eligibility Criteria

Age Range56 Days to 83 Days
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion criteria: * healthy male or female, between, and including, 56 and 83 days of age. * Born after a gestation period between 36 and 42 weeks * Birth dose of hepatitis B vaccine within the first 72 hours of life Exclusion criteria: * planned administration/administration of a vaccine not f...

Countries:Thailand
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Frequently asked questions about Hib-MenAC mixed with Tritanrix-HepB

What is Hib-MenAC mixed with Tritanrix-HepB used for?

Hib-MenAC mixed with Tritanrix-HepB is an investigational combination vaccine being studied for the prevention of tetanus, hepatitis B, Haemophilus influenzae type b, whole cell pertussis, and diphtheria in infants. It is currently in Phase 3 clinical development.

Who makes Hib-MenAC mixed with Tritanrix-HepB?

Hib-MenAC mixed with Tritanrix-HepB is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK.

What phase is Hib-MenAC mixed with Tritanrix-HepB in?

Hib-MenAC mixed with Tritanrix-HepB is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 trial has been completed.

What clinical trials is Hib-MenAC mixed with Tritanrix-HepB in?

Hib-MenAC mixed with Tritanrix-HepB has one completed Phase 3 trial, NCT00197275, titled 'Lot-to-lot Consistency of Tritanrix™-HepB/Hib-MenAC & Its Non-inferiority vs Tritanrix™-HepB/Hiberix™ in Infants'. The trial enrolled 800 participants in Thailand.

How does Hib-MenAC mixed with Tritanrix-HepB work?

Hib-MenAC mixed with Tritanrix-HepB is a combination vaccine designed to stimulate the immune system to produce protective antibodies against tetanus, hepatitis B, Haemophilus influenzae type b, whole cell pertussis, and diphtheria. It is administered to infants starting at 56 days of age.