deltatrials
Unknown OBSERVATIONAL NCT01472575

Impact of Rotavirus Vaccine Introduction for South Australian Children

An Observational, Cross-sectional, Cohort Study to Assess the Impact of the Rotavirus Vaccine Introduction on Severe Gastroenteritis in South Australian Children

Sponsor: Associate Professor Helen Marshall

Updated 7 times since 2017 Last updated: Nov 15, 2011 Started: May 31, 2009 Primary completion: Dec 31, 2011 Completion: Dec 31, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Gastroenteritis and Viral Gastroenteritis Due to Rotavirus, this trial is ongoing. The trial is conducted by Associate Professor Helen Marshall and has accumulated 7 data snapshots since 2009. Infectious disease trials contribute critical data for public health response and treatment development.

Study Description(click to expand)

This project aims to assess vaccine effectiveness in the field following introduction of the rotavirus vaccine in South Australian children. It is important to confirm the benefits of the vaccine post licensure to ensure the best health care options for children. Between July 2007 - June 2008 at the Women's and Children's Hospital, there were approximately 2000 gastroenteritis patient samples analysed, with approximately 200 of these confirmed as rotavirus positive (10%). The current vaccines available in Australia (Rotarix® and RotaTeq® ) are licensed for administration in infants up to six months of age as safety data is not yet available for older children. It is therefore important to determine whether vaccination according to the current Australian Standard Vaccination Schedule can also demonstrate a positive change (less disease and less severe disease) in the burden of rotavirus disease in older unvaccinated children.

This project aims to assess vaccine effectiveness in the field following introduction of the rotavirus vaccine in South Australian children. It is important to confirm the benefits of the vaccine post licensure to ensure the best health care options for children. Between July 2007 - June 2008 at the Women's and Children's Hospital, there were approximately 2000 gastroenteritis patient samples analysed, with approximately 200 of these confirmed as rotavirus positive (10%). The current vaccines available in Australia (Rotarix® and RotaTeq® ) are licensed for administration in infants up to six months of age as safety data is not yet available for older children. It is therefore important to determine whether vaccination according to the current Australian Standard Vaccination Schedule can also demonstrate a positive change (less disease and less severe disease) in the burden of rotavirus disease in older unvaccinated children.

Status Flow

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshotUnknown Status~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotUnknown Status~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotUnknown Status~Jan 2021 – ~Jun 2022 · 17 months · monthly snapshotUnknown Status~Jun 2022 – ~Jul 2024 · 25 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 19 months · monthly snapshotUnknown

Change History

7 versions recorded
  1. Sep 2024 — Present [monthly]

    Unknown

  2. Jul 2024 — Sep 2024 [monthly]

    Unknown

    Status: Unknown StatusUnknown

  3. Jun 2022 — Jul 2024 [monthly]

    Unknown Status

  4. Jan 2021 — Jun 2022 [monthly]

    Unknown Status

  5. Jun 2018 — Jan 2021 [monthly]

    Unknown Status

Show 2 earlier versions
  1. Apr 2018 — Jun 2018 [monthly]

    Unknown Status

    Phase: NANone

  2. Jan 2017 — Apr 2018 [monthly]

    Unknown Status NA

    First recorded

May 2009

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Associate Professor Helen Marshall
  • Merck Sharp & Dohme LLC
Data source: Women's and Children's Hospital, Australia

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

Study Locations