deltatrials
Completed PHASE1 NCT00280111

Safety and Immunogenicity Study of Live Attenuated Indian Rotavirus Vaccine Candidate Strains 116E and I321 in Infants

Reactogenicity and Immunogenicity of Live Attenuated Indian Rotavirus Vaccine Candidate Strains 116E and I321 in Healthy Non-Malnourished Infants 8-12 Weeks of Age

Sponsor: All India Institute of Medical Sciences

Updated 6 times since 2017 Last updated: Jul 1, 2008 Started: Jan 31, 2005 Primary completion: May 31, 2005 Completion: May 31, 2005

A PHASE1 clinical study on Rotavirus Infections, this trial is completed. The trial is conducted by All India Institute of Medical Sciences and has accumulated 6 data snapshots since 2005. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Jul 2025 · 10 months · monthly snapshotCompleted~Jul 2025 – present · 9 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Jul 2025 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Jul 2025 [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1

Show 1 earlier version
  1. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE1

    First recorded

Jan 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • All India Institute of Medical Sciences
  • Centers for Disease Control and Prevention
  • Children's Hospital Medical Center, Cincinnati
  • Indian Institute of Science
  • Ministry of Science and Technology, India
  • National Institutes of Health (NIH)
  • PATH
  • Society for Applied Studies
  • Stanford University
Data source: Society for Applied Studies

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations