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Adacel

Phase 3

Diphtheria | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: May 16, 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

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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