deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT00363545

To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)

A Study to Assess the Immunogenicity, Reactogenicity and Safety of 2 Different Formulations of GSK Biologicals' Live Attenuated HRV Vaccine, Given as a Two-dose Primary Vaccination, in Healthy Infants Previously Uninfected With HRV

Sponsor: GlaxoSmithKline

Conditions Infections, Rotavirus
Interventions Liquid formulation of HRV vaccine Lyophilized formulation of HRV vaccine
Updated 9 times since 2017 Last updated: May 9, 2018 Started: Sep 1, 2006 Primary completion: Apr 12, 2007 Completion: Apr 12, 2007
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00363545, this PHASE3 trial focuses on Infections, Rotavirus and remains completed. Sponsored by GlaxoSmithKline, it has been updated 9 times since 2006, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~May 2017 · 3 months · monthly snapshotCompleted~May 2017 – ~Jun 2018 · 13 months · monthly snapshotCompleted~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshotCompleted~Jul 2018 – ~Jan 2021 · 30 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 12 months · monthly snapshotCompleted

Change History

9 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jul 2018 — Jan 2021 [monthly]

    Completed PHASE3

▶ Show 4 earlier versions

  1. Jun 2018 — Jul 2018 [monthly]

    Completed PHASE3

  2. May 2017 — Jun 2018 [monthly]

    Completed PHASE3

  3. Feb 2017 — May 2017 [monthly]

    Completed PHASE3

  4. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE3

    First recorded

Sep 2006

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • GlaxoSmithKline
Data source: GlaxoSmithKline

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

Study Locations