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A phase III, multicenter, randomized, open labeled study to evaluate the immunogenicity, reactogenicity and safety of ROTAVAC 5CM of the live attenuated rotavirus vaccine as a 3 dose series when compared with existing ROTAVACÂ in healthy infants aged 6-8 weeks - ROTAVAC5CM

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A phase III, multicenter, randomized, open labeled study to evaluate the immunogenicity, reactogenicity and safety of ROTAVAC 5CM of the live attenuated rotavirus vaccine as a 3 dose series when compared with existing ROTAVACÂ in healthy infants aged 6-8 weeks - ROTAVAC5CM

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Jul 2019

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At a glance

  • Drugs ORV 116E (Primary) ; Rotavirus vaccine
  • Indications Rotavirus infections
  • Focus Pharmacodynamics
  • Sponsors Bharat Biotech

    • Most Recent Events

    • 12 Nov 2018 Status changed from recruiting to completed.
    • 28 Dec 2016 Status changed from not yet recruiting to recruiting.
    • 13 Dec 2016 New trial record

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