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GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment806

FDA Designations

No designations recorded

Clinical trial landscape

GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine · 1 trial · 3 indications

Phase 3 1
NCT01277705Comparison of GSK Biologicals' Reduced Antigen Diphtheria and Tetanus Toxoids and Acellular Pertussis- Inactivated Poliovirus Vaccine, to BoostrixTM and Inactivated Poliovirus Vaccine Administered Separately and With Revaxis®Tetanus
COMPLETED806 Analytics
PHASE3COMPLETED
Comparison of GSK Biologicals' Reduced Antigen Diphtheria and Tetanus Toxoids and Acellular Pertussis- Inactivated Poliovirus Vaccine, to BoostrixTM and Inactivated Poliovirus Vaccine Administered Separately and With Revaxis®
Tetanus
NCT01277705806
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Study Endpoints

Primary Endpoints

Immunogenicity with respect to components of the study vaccines
One month after vaccination (Month 1)

Secondary Endpoints

Immunogenicity with respect to components of the study vaccines
One month after vaccination (Month 1)
Immunogenicity with respect to some component of the study vaccines
At Day 10 after vaccination
Occurrence of solicited local and general symptoms
within 15 (Day 0-14) days after vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTAL -
Group BEXPERIMENTAL -
Group CACTIVE_COMPARATOR -

Interventions

NameTypeDescription
GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccineBIOLOGICALIntramuscular, single
Boostrix™BIOLOGICALIntramuscular, single dose
GSK Biologicals' IPV vaccineBIOLOGICALIntramuscular, single dose
Revaxis®BIOLOGICALIntramuscular, single dose
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Eligibility Criteria

Age Range15 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * A male or female subjects aged 15 years and over (Germany), or 18 years and over (France) at the time of the vaccination. * Written informed consent obtained. * Free of obvious health problems Having received primary vaccination with diphtheria and tetanus vaccines to the best...

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