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Infanrix-Hexa

Phase 3

Hepatitis B | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Sep 16, 2016

Target and mechanism

ModalityMonoclonal antibody

Also known as Infanrix hexa

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

Infanrix-Hexa · 1 trial · 1 indication

Phase 3 1
NCT00366366To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV VaccinesHepatitis B
COMPLETED150 Analytics
PHASE3COMPLETED
To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV Vaccines
Hepatitis BUnlock trial analytics

Study Endpoints

Primary Endpoints

Anti-HBs conc >=10 mIU/ml, 1 month after the last vaccine dose

Secondary Endpoints

Ab conc/titers against all vaccine antigens
Safety: Solicited symptoms, unsolicited AEs and SAEs
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Infanrix-HexaBIOLOGICAL -
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Eligibility Criteria

Age Range11 Weeks to 17 Weeks
SexALL
Healthy VolunteersYes

Inclusion Criteria: * A male or female infant at the age of 11 - 17 weeks. * Written informed consent obtained from the parents or guardians of the subject. * Free of obvious health problems as established by clinical examination before entering into the study. * Hepatitis B vaccine at birth and on...

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Frequently asked questions about Infanrix-Hexa

What is Infanrix hexa used for?

Infanrix hexa is a vaccine used to protect against tetanus, acellular pertussis, streptococcal infections, poliomyelitis, and hepatitis B. It is administered to infants to provide immunity against these infectious diseases. The vaccine is developed by GSK plc and is currently in Phase 3 clinical development.

Who makes Infanrix hexa?

Infanrix hexa is developed by GSK plc, a biopharmaceutical 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 infants.

What phase is Infanrix hexa in?

Infanrix hexa is in Phase 3 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. GSK plc is conducting multiple Phase 3 trials to assess its safety and effectiveness in preventing infectious diseases.

What clinical trials is Infanrix hexa in?

Infanrix hexa has been studied in several completed clinical trials, including NCT00366366, NCT01248884, NCT01353703, and NCT02096263. These trials evaluated the vaccine's immunogenicity and safety in infants across different countries, with a total enrollment of 1,597 participants.

How does Infanrix hexa work?

Infanrix hexa is a vaccine that works by stimulating the immune system to produce antibodies against the antigens for tetanus, acellular pertussis, streptococcal infections, poliomyelitis, and hepatitis B. This helps protect infants from these infectious diseases.

Is Infanrix hexa the same as DTPa-HBV-IPV/Hib vaccine?

Infanrix hexa is also known as the DTPa-HBV-IPV/Hib vaccine, which combines diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b antigens. Clinical trials refer to it by this alternative name.