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DTPa-HBV-IPV/Hib vaccine

Phase 3

Diphtheria | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Oct 12, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment639

FDA Designations

No designations recorded

Clinical trial landscape

DTPa-HBV-IPV/Hib vaccine · 2 trials · 6 indications

Phase 3 2
NCT00320463Compare Immunogenicity & Safety of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Given in Healthy InfantsDiphtheria
COMPLETED415 Analytics
NCT00316147Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination SchedulesDiphtheria
COMPLETED224 Analytics
PHASE3COMPLETED
Compare Immunogenicity & Safety of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants
Diphtheria
NCT00320463415
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PHASE3COMPLETED
Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination Schedules
Diphtheria
NCT00316147224
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Study Endpoints

Primary Endpoints

One month after vaccination, measurement of antibodies against all vaccine antigens.
1M post-dose 3, vaccine response for pertussis and anti-poliovirus types 1, 2, and 3 titers

Secondary Endpoints

Immunogenicity: One month after vaccination, vaccine response for the pertussis antigens.
Reactogenicity & safety: After each dose, solicited (day 0-3, local & general) & unsolicited (day 0-30) symptoms. Over the full course of the study: serious adverse events (SAEs)."
1M post-dose 3, antibody levels against all antigens
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
DTPa-HBV-IPV/Hib vaccineBIOLOGICAL -
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Eligibility Criteria

Age Range11 Weeks to 17 Weeks
SexALL
Healthy VolunteersYes
Study Sites4

"Inclusion criteria: * A healthy male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination. * Infant born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample is a...

Countries:RussiaIndia
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Frequently asked questions about DTPa-HBV-IPV/Hib vaccine

What is DTPa-HBV-IPV/Hib used for?

DTPa-HBV-IPV/Hib is an investigational combination vaccine being studied for use in preventing Hepatitis B, Diphtheria, and Haemophilus Influenzae Type b infections. It is designed for administration to infants, with clinical trials evaluating its safety and immunogenicity in this population.

Who makes DTPa-HBV-IPV/Hib?

DTPa-HBV-IPV/Hib is being developed by GSK plc, a biopharmaceutical company traded on the London Stock Exchange under the ticker GSK. The company has sponsored multiple clinical trials to evaluate the vaccine's safety and immunogenicity.

What phase is DTPa-HBV-IPV/Hib in?

DTPa-HBV-IPV/Hib is in Phase 3 clinical development. It remains investigational and has not been approved by regulatory authorities. Completed trials include both Phase 2 and Phase 3 studies assessing the vaccine in infant populations.

What clinical trials is DTPa-HBV-IPV/Hib in?

DTPa-HBV-IPV/Hib has been studied in five completed clinical trials, including NCT00289796, NCT00325143, NCT01457495, and NCT01457508. These trials evaluated the vaccine's safety and immunogenicity in infants, with total enrollment of 1,093 participants across the studies.

Is DTPa-HBV-IPV/Hib the same as DTPa-HBV-IPV+Hib?

Yes, DTPa-HBV-IPV/Hib is also known as DTPa-HBV-IPV+Hib. Both names refer to the same investigational combination vaccine being developed by GSK plc for prevention of Hepatitis B, Diphtheria, and Haemophilus Influenzae Type b infections.

How does DTPa-HBV-IPV/Hib work?

DTPa-HBV-IPV/Hib is a combination vaccine intended to stimulate an immune response against multiple diseases. It contains components targeting Hepatitis B, Diphtheria, and Haemophilus Influenzae Type b, along with other vaccine antigens, to help protect infants from these infections.