Safety and Immunogenicity of DTap-IPV (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined With Inactivated Poliovirus Vaccine) Compared to DAPTACEL (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) + IPOL (Poliovirus Vaccine Inactivated) as the 5th Dose in Children 4 to 6 Years of Age

Trial Profile

Safety and Immunogenicity of DTap-IPV (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined With Inactivated Poliovirus Vaccine) Compared to DAPTACEL (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) + IPOL (Poliovirus Vaccine Inactivated) as the 5th Dose in Children 4 to 6 Years of Age

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jun 2015

At a glance

  • Drugs DTaP poliovirus vaccine (Primary) ; DTaP vaccine; Measles mumps and rubella virus vaccine; Poliovirus vaccine inactivated; Varicella zoster virus vaccine live
  • Indications Chickenpox; Diphtheria; Measles; Mumps; Pertussis; Poliomyelitis; Rubella; Tetanus; Varicella zoster virus infections
  • Focus Pharmacodynamics
  • Most Recent Events

    • 25 Mar 2015 According to Sanofi Pasteur media release, DTaP-poliovirus-vaccine [Quadracel] has been approved by the US FDA for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children 4 through 6 years of age, based on data from this trial.
    • 01 Sep 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 11 Jul 2013 Actual patient number added 3372 according to ClinicalTrials.gov.
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