drugset
Drugs / Rotavirus
last change Jul 2025 re-read 9 days ago

Rotavirus

also known as HRV · RotaTeq Rotavirus Vaccine, Live, Oral, Pentavalent

Vaccine

Developed for
Rotavirus infection
Investigated by
GlaxoSmithKline · Centers for Disease Control and Prevention · Children's Hospital Medical Center, Cincinnati · Columbia University · Duke University · Hospices Civils de Lyon
+4 more · Kaiser Permanente · Malaria Research and Training Center, Bamako, Mali · Novartis Vaccines · University of Oxford

Trials 7

today NCT06038617 · Ph 4 NCT05155579 · Ph 1 NCT03180359 · not/applicable NCT00474526 · Ph 3 NCT00140686 · Ph 3 NCT00197210 · Ph 3 NCT00140673 · Ph 3
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT05155579 May 2022 → May 2025 malaria University of Oxford Completed No outcome recorded
Phase 34 trials · 1 met primary
Phase 3 NCT00474526 Mar 2007 → Sep 2008 meningococcal meningitis Novartis Vaccines Completed Met primary
Phase 3 NCT00140686 Sep 2004 → Aug 2006 Rotavirus infection GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT00197210 Dec 2003 → Jul 2007 Rotavirus infection GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT00140673 Aug 2003 → Oct 2005 Rotavirus infection GlaxoSmithKline Completed No outcome recorded
Phase 41 trial
Phase 4 NCT06038617 Oct 2023 → Apr 2025 — Duke University Completed No outcome recorded
Phase not applicable1 trial
— NCT03180359 Jan 2016 → Oct 2019 disease related to transplantation Hospices Civils de Lyon Completed No outcome recorded
Comparator or background therapy1 trial
Phase 3 NCT02174705 Comparator Jun 2014 → Sep 2015 — Anna Taddio Unknown No outcome recorded

Press releases naming this drug 9 releases

DateIssuerRelease
2021-03-04 GlaxoSmithKline GSK makes landmark pricing agreement for rotavirus vaccine, Rotarix, for use with children living in humanitarian crises gsk.com ↗
2011-06-06 GlaxoSmithKline Millions of children in the world’s poorest countries could receive vaccination against rotavirus diarrhoeal disease under new offer made by GSK to the GAVI Alliance gsk.com ↗
2010-05-20 GlaxoSmithKline European Medicines Agency maintains position on the continued use of Rotarix™ (rotavirus vaccine) gsk.com ↗
2010-05-13 GlaxoSmithKline FDA says Healthcare Providers can resume use of Rotarix (Rotavirus Vaccine, Live, Oral) gsk.com ↗
2010-05-07 GlaxoSmithKline GSK Statement on FDA Advisory Committee meeting on Rotavirus vaccines gsk.com ↗
2010-03-25 GlaxoSmithKline Updated GlaxoSmithKline statement on European regulatory guidance relating to manufacture of Rotarix (rotavirus vaccine) gsk.com ↗
2010-03-21 GlaxoSmithKline GlaxoSmithKline statement on new information relating to manufacture of Rotarix (rotavirus vaccine) gsk.com ↗
2010-01-26 GlaxoSmithKline Rotarix™ significantly reduced severe rotavirus gastroenteritis in African babies during their first year of life gsk.com ↗
2009-11-29 GlaxoSmithKline Regulatory Update: GSK files Rotarix for prevention of rotavirus in Japan gsk.com ↗

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 8 sources stand behind the page.

FieldValueCited text
Known as Rotavirus “Pneumococcal, DTaP, Haemophilus Influenzae Type B, MMR, Varicella, MMRV, Hepatitis A, Inactivated Poliovirus, Hepatitis B, Rotavirus, Influenza vaccines” NCT06038617 ↗
7

“* Rotavirus” NCT03180359 ↗

NCT05155579 ↗

NCT00197210 ↗

NCT00474526 ↗

NCT02174705 ↗

NCT00140673 ↗

NCT00140686 ↗
Known as HRV “GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine” NCT00140673 ↗
1

“Human Rotavirus (HRV) Vaccine” NCT00140686 ↗
Known as RotaTeq Rotavirus Vaccine, Live, Oral, Pentavalent “RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent” NCT00474526 ↗
Modality Vaccine “HRV Vaccine” NCT00140673 ↗
Route Oral “Two oral doses administered to healthy infants” NCT00140673 ↗