Drugs / Rotavirus vaccine

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Rotashield — 1999-05-07 europa.eu ↗

Trials 7

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT00981669 Mar 2009 → Mar 2010 Rotavirus infection Butantan Institute Completed No outcome recorded
Phase 23 trials
Phase 2 NCT02482636 Aug 2015 → Nov 2017 infectious disease University of Oxford Completed No outcome recorded
Phase 2 NCT01049035 Dec 2009 → Feb 2012 meningitis, meningococcal infection Sanofi Pasteur, a Sanofi Company Completed No outcome recorded
Phase 2 NCT00346892 Nov 2001 → Mar 2003 Rotavirus infection GlaxoSmithKline Completed No outcome recorded
Phase 43 trials · 1 met primary · 1 missed
Phase 4 NCT02153866 Dec 2013 → May 2014 Rotavirus infection Sichuan Center for Disease Control and Prevention Unknown No outcome recorded
Phase 4 NCT01616693 Jul 2012 → Jul 2013 — PATH Completed Met primary
Phase 4 NCT01199874 Apr 2011 → Sep 2012 Rotavirus infection PATH Completed Missed primary
Comparator or background therapy3 trials
Phase 3 NCT06397768 Background May 2024 → Sep 2025 respiratory syncytial virus infectious disease Sanofi Pasteur, a Sanofi Company Terminated No outcome recorded Stop: Business
Phase 3 NCT05794230 Background Mar 2023 → Nov 2025 meningococcal infection Sanofi Pasteur, a Sanofi Company Completed No outcome recorded
Phase 3 NCT03673462 Background Sep 2018 → Mar 2023 — Sanofi Pasteur, a Sanofi Company Completed No outcome recorded

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 10 sources stand behind the page.

FieldValueCited text
Known as rotavirus vaccine ClinicalTrials.gov intervention name — accepted as the source's own label NCT02153866 ↗
9

NCT03673462 ↗

NCT05794230 ↗

NCT01616693 ↗

NCT00346892 ↗

NCT02482636 ↗

NCT01199874 ↗

NCT06397768 ↗

NCT00981669 ↗

NCT01049035 ↗

Known as RotaTeq “RotaTeq® (rotavirus vaccine) at 2, 4, and 6 months of age” NCT03673462 ↗
Modality Vaccine “Oral Live Attenuated HRV Vaccine” NCT00346892 ↗
Route Oral “Oral Live Attenuated HRV Vaccine” NCT00346892 ↗