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Combined diphtheria, tetanus, acellular pertussis vaccine

Phase 3

Diphtheria | Vaccine | Infectious Disease |GSK plc|Last Updated: Sep 9, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment4,116

FDA Designations

No designations recorded

Clinical trial landscape

Combined diphtheria, tetanus, acellular pertussis vaccine · 1 trial · 3 indications

Phase 3 1
NCT00109330A Combined Tdap Vaccine Used As A Booster Compared To Licensed Td VaccineDiphtheria
COMPLETED4,116 Analytics
PHASE3COMPLETED
A Combined Tdap Vaccine Used As A Booster Compared To Licensed Td Vaccine
DiphtheriaUnlock trial analytics

Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Combined diphtheria, tetanus, acellular pertussis vaccineBIOLOGICAL -
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Eligibility Criteria

Age Range10 Years to 18 Years
SexALL
Healthy VolunteersYes
Study Sites44

Inclusion Criteria: * Healthy adolescents with history of completed routine vaccination against diphtheria, tetanus, and pertussis (DTP). Exclusion Criteria: * Use of any other investigational drug or vaccine 30 days preceding study vaccination. * Chronic administration of immunosuppressants. * A...

Countries:United States
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Frequently asked questions about Combined diphtheria, tetanus, acellular pertussis vaccine

What is the combined diphtheria, tetanus, acellular pertussis vaccine?

The combined diphtheria, tetanus, acellular pertussis vaccine is a vaccine designed to protect against three bacterial infections: diphtheria, tetanus, and acellular pertussis. It is developed by GSK plc and is given as a booster dose. The vaccine is in Phase 3 clinical development.

What is the combined diphtheria, tetanus, acellular pertussis vaccine used for?

The combined diphtheria, tetanus, acellular pertussis vaccine is used for immunization against diphtheria, tetanus, and acellular pertussis. It is studied as a booster in people aged 10 years and older. The Phase 3 trial enrolled healthy volunteers in the United States.

Who makes the combined diphtheria, tetanus, acellular pertussis vaccine?

GSK plc, which trades under the ticker GSK, is the developer of the combined diphtheria, tetanus, acellular pertussis vaccine. The company conducted the Phase 3 trial evaluating the vaccine as a booster compared with a licensed Td vaccine.

What phase is the combined diphtheria, tetanus, acellular pertussis vaccine in?

The combined diphtheria, tetanus, acellular pertussis vaccine is in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The vaccine is investigational and has not been approved by the FDA based on the available development information.

What clinical trials is the combined diphtheria, tetanus, acellular pertussis vaccine in?

The combined diphtheria, tetanus, acellular pertussis vaccine was evaluated in the Phase 3 trial NCT00109330, titled A Combined Tdap Vaccine Used As A Booster Compared To Licensed Td Vaccine. The completed trial enrolled 4,116 participants aged 10 years and older in the United States and was randomized but uncontrolled.