• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Daptacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Daptacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine)

  • Profile

Profile

Contact Information

Contact: Sanofi Pasteur
Website: https://www.sanofi.us/dam/jcr:33b88796-7921-47ff-8e45-29b0060cdef4/Prescribing-Information%20(2).pdf

Currently Enrolling Trials

    Show More

    General Information

    Daptacel is a diptheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP), approved for routine immunization in infants and children six weeks through six years of age. It is administered via intramuscular injection in four consecutive doses of the five dose immunization series. The four doses are given at approximately two months, four months, six months and six months after the third dose.

    Mechanism of Action

    Daptacel is a DTaP vaccine given in four consecutive intramuscular doses. The DTaP is about 10 times less likely to cause adverse reactions than the older DTP is. While the DTP contains the whole, inactivated pertussis bacteria, the DTaP uses only the parts of the bacteria that help the infant or child develop immunity to it and leaves behind the other parts that may have been responsible for many of the DTP's adverse effects.

    Side Effects

    Adverse events associated with the use of Daptacel may include (but are not limited to) the following:

    • Drowsiness
    • Irritability
    • Anorexia
    • Injection site irritation

    Clinical Trial Results

    Approval of Daptacel is supported by data from clinical trials conducted in Sweden, Canada and the United States. In Sweden, close to 1,000 infants were randomized to receive one of four vaccines for the treatment of pertussis. These included Daptacel, another investigational acellular pertussis vaccine, whole-cell pertussis DTP vaccine or DT vaccine as placebo. During a follow-up two years after administration of the third dose, the protective efficacy of Daptacel was 85%. Identical studies performed in the United States and Canada produced similar results.

    Canadian and United States clinical studies evaluated Daptacel as a preventative for diptheria and tetanus in children. After four doses of the vaccine, the portion of children with diptheria and tetanus antitoxin levels greater then or equal to a serological correlate of protection defined by the Panel on Review of Bacterial Vaccines and Toxoids, was close to 100% in both studies.

    Approval Date: 2002-05-01
    Company Name: Sanofi Pasteur
    Back to Listings

    Upcoming Events

    • 16Feb

      Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

    • 21May

      WCG MAGI Clinical Research Conference – 2023 East

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • Revamp-360x240.png

      Califf Calls for Major Evidence Generation Revamp, Experts’ Opinions Differ

    • AskTheExpertsGreen-360x240.png

      Ask the Experts: Managing Investigational Products

    • SurveywBlueBackground-360x240.png

      Survey Outlines Site Challenges, Successes on Diversity

    • PatientCentricity-360x240.png

      Site Spotlight: DM Clinical Shows Patient Centricity Doesn’t Have to Break the Bank

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing