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diphtheria, tetanus, pertussis & Hib vaccine

Phase 3

Tetanus | 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

UNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

diphtheria, tetanus, pertussis & Hib vaccine · 1 trial · 4 indications

Phase 3 1
NCT00379977Study to Assess the Safety & Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Given at 3, 4 and 5 Months of AgeTetanus
COMPLETED30 Analytics
PHASE3COMPLETED
Study to Assess the Safety & Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Given at 3, 4 and 5 Months of Age
TetanusUnlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence of solicited symptoms during the 4 days following vaccination, unsolicited symptoms during the 31 days following vaccination and serious adverse events
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Interventions

NameTypeDescription
diphtheria, tetanus, pertussis & Hib vaccineBIOLOGICAL -
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Eligibility Criteria

Age Range90 Days to 120 Days
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * A male or female between, and including, 90 and 120 days of age at the time of the first vaccination Written informed consent obtained from the parent or guardian of the subject Exclusion Criteria: * subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemo...

Countries:China
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Frequently asked questions about diphtheria, tetanus, pertussis & Hib vaccine

What is diphtheria, tetanus, pertussis & Hib vaccine used for?

Diphtheria, tetanus, pertussis & Hib vaccine is a combination vaccine being studied for use in preventing tetanus, diphtheria, acellular pertussis, and Haemophilus influenzae type b infections. It is currently in Phase 3 clinical development as an investigational vaccine for these infectious diseases.

Who makes diphtheria, tetanus, pertussis & Hib vaccine?

GSK plc (ticker: GSK) is developing diphtheria, tetanus, pertussis & Hib vaccine. The company is conducting clinical trials to evaluate the vaccine's safety and reactogenicity in infants.

What phase is diphtheria, tetanus, pertussis & Hib vaccine in?

Diphtheria, tetanus, pertussis & Hib vaccine 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 to assess its safety and reactogenicity.

What clinical trials is diphtheria, tetanus, pertussis & Hib vaccine in?

Diphtheria, tetanus, pertussis & Hib vaccine has one completed Phase 3 clinical trial, NCT00379977, which assessed its safety and reactogenicity when given at 3, 4, and 5 months of age. The trial enrolled 30 healthy infants in China and was not randomized or blinded.

Is diphtheria, tetanus, pertussis & Hib vaccine FDA approved?

Diphtheria, tetanus, pertussis & Hib vaccine is not FDA approved. It is an investigational vaccine currently in Phase 3 clinical development. The completed trial evaluated safety and reactogenicity, but the vaccine has not yet received regulatory approval.