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A Phase 3, Multicenter, Open-Label, Randomized Clinical Trial to evaluate Safety and Immunogenicity of ROTAVAC -20C and Rotavac 5CM administered at Birth (Neonatal Schedule) and Additional Dose versus Infant Schedule against Rotavirus Gastroenteritis

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Trial Profile

A Phase 3, Multicenter, Open-Label, Randomized Clinical Trial to evaluate Safety and Immunogenicity of ROTAVAC -20C and Rotavac 5CM administered at Birth (Neonatal Schedule) and Additional Dose versus Infant Schedule against Rotavirus Gastroenteritis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jan 2020

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At a glance

  • Drugs ORV 116E (Primary)
  • Indications Gastroenteritis; Rotavirus infections
  • Focus Adverse reactions
  • Sponsors Bharat Biotech

Most Recent Events

  • 05 Nov 2019 Status changed from recruiting to completed.
  • 26 Sep 2019 New trial record

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