A Phase III Randomised, Open, Controlled Study to Assess the Safety and Immunogenicity of Concomitant Administration of Virosomal Hepatitis A Vaccine (Epaxal) With DTPaHibIPV, OPV and MMR Vaccines vs. Non-concomitant Administration in 12-15 Month Old Children. Follow-up: Serological Long-term Follow-up of Subjects for up to 42 Months, 5.5 and 7.5 Years After the Second Dose.

Trial Profile

A Phase III Randomised, Open, Controlled Study to Assess the Safety and Immunogenicity of Concomitant Administration of Virosomal Hepatitis A Vaccine (Epaxal) With DTPaHibIPV, OPV and MMR Vaccines vs. Non-concomitant Administration in 12-15 Month Old Children. Follow-up: Serological Long-term Follow-up of Subjects for up to 42 Months, 5.5 and 7.5 Years After the Second Dose.

Completed
Phase of Trial: Phase III

Latest Information Update: 18 Apr 2016

At a glance

  • Drugs Hepatitis A vaccine inactivated (Primary) ; Hib-DTaP-poliovirus vaccine; Measles mumps and rubella virus vaccine; Poliovirus vaccine live oral
  • Indications Diphtheria; Haemophilus infections; Hepatitis A; Measles; Mumps; Pertussis; Poliomyelitis; Rubella; Tetanus
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors Crucell
  • Most Recent Events

    • 18 Apr 2016 Results from follow-up part of the study (n=228) published in the Pediatric Infectious Disease Journal
    • 28 Jul 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
    • 29 Apr 2014 According to the ClinicalTrials.gov record, planned end date changed from 1 Dec 2013 to 1 Apr 2014.
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