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A randomized open label multi-center study to compare immunogenicity and safety of BBIL's ROTAVAC to GSK's ROTARIX rotavirus vaccine when administered orally to infants aged 6-8 weeks

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Trial Profile

A randomized open label multi-center study to compare immunogenicity and safety of BBIL's ROTAVAC to GSK's ROTARIX rotavirus vaccine when administered orally to infants aged 6-8 weeks

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 03 Jul 2019

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At a glance

  • Drugs ORV 116E (Primary) ; RIX 4414
  • Indications Rotavirus infections
  • Focus Pharmacodynamics
  • Sponsors Bharat Biotech

    • Most Recent Events

    • 06 Jun 2019 Primary endpoint (The difference in immunogenicity (GMTs) achieved with ROTAVAC , when administered orally as 3-dose regimen at 4(+1) weeks interval starting at 6-8 weeks of age is not inferior at the predefined margin to that achieved with ROTARIX,when administered orally as 2-dose regimen at 4(+1) weeks interval starting at 6-8 weeks of age) has been met, according to the results published in the Vaccine.
    • 06 Jun 2019 Results published in the Vaccine
    • 25 Aug 2016 New trial record

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