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Adacel

Phase 4

Diphtheria | Vaccine | Infectious Disease |Sanofi|Trials Updated: May 16, 2016

Adacel development status

Highest phase Phase 4 (NCT04543669)
Phase scored for SNYPhase 3
Registered trials 10 across 7 sponsors since Jun 2006

Adacel target and mechanism

Target class-Cel (Cell Tx)
ModalityVaccine

Also known as SP306 (in Japan), Tdap

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Adacel clinical trials

Adacel · 1 trial · 3 indications

Phase 3 1
NCT01040052A Study to Assess the Safety of Adacel® VaccineDiphtheria
COMPLETED30 Analytics
PHASE3COMPLETED
A Study to Assess the Safety of Adacel® Vaccine
DiphtheriaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine
Days 0-7 Post-vaccination

Solicited injection site reactions: Pain, itchiness, erythema (redness), and swelling. Solicited systemic reactions: Headache, body ache and muscle weakness, tiredness, chill, nausea, vomiting, rash, itchiness, anorexia, sore and swollen joints, diarrhea, lymph node swelling, and fever (temperature).

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Study GroupEXPERIMENTAL -

Interventions

NameTypeDescription
Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)BIOLOGICAL0.5 mL, Intramuscular
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria : * Male or female (not pregnant) from 18-45 years of age. * Healthy, with no current illnesses. * Have not been immunized against diphtheria, pertussis and tetanus in the past 5 years. * Women of childbearing age will agree to use birth control during the study. * In good health...

Countries:Vietnam
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Frequently asked questions about Adacel

What is Adacel?

Adacel is a vaccine developed by Sanofi for the prevention of diphtheria, tetanus, and pertussis. It is a tetanus, reduced diphtheria toxoid, and acellular pertussis vaccine. Adacel is also known as Adacel (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis). It is used in infectious disease prevention.

What is Adacel used for?

Adacel is used for immunization against diphtheria, tetanus, and pertussis. It is indicated for active booster immunization against these three diseases. The vaccine is designed to protect individuals from diphtheria, a serious bacterial infection, as well as tetanus and pertussis.

Who makes Adacel?

Adacel is made by Sanofi, a global pharmaceutical company. Sanofi trades under the ticker symbol SNY. The company develops and manufactures Adacel as part of its vaccine portfolio. Sanofi is the developer responsible for the clinical development and production of Adacel.

What phase is Adacel in?

Adacel is in Phase 3 clinical development. A completed Phase 3 trial, NCT01040052, assessed the safety of Adacel vaccine. The trial enrolled 30 participants in Vietnam. Adacel is an investigational vaccine and has been studied in a Phase 3 trial for safety.

What clinical trials is Adacel in?

Adacel has been studied in a completed Phase 3 clinical trial, NCT01040052, titled A Study to Assess the Safety of Adacel Vaccine. The trial enrolled 30 participants aged 18 years and older in Vietnam. It was an uncontrolled, non-randomized study that included healthy volunteers.