Rotavirus Gastroenteritis
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EMA approval · 2026-06-04EMA Authorised: Rotarix (human rotavirus, live attenuated) — GlaxoSmithKline Biologicals S.A.
Rotarix, a live attenuated human rotavirus vaccine, has been authorised for use in the European Union to prevent rotavirus infections.
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EMA approval · 2026-04-22EMA Authorised: Rotarix (human rotavirus, live attenuated) — GlaxoSmithKline Biologicals S.A.
The European Medicines Agency authorised Rotarix, a live attenuated human rotavirus vaccine, for active immunization against rotavirus infec…
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CLINICAL_TRIALS trial_result · 2026-03-20Clinical Trial Update: The Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells) [Phase 1]
A Phase 1 clinical trial evaluating an oral hexavalent reassortant rotavirus vaccine produced in Vero cells has completed.
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CLINICAL_TRIALS trial_result · 2025-12-31Clinical Trial Update: Evaluation of the Role of Vitamin D in Reducing the Severity and Duration of Rotavirus Infection in Iraqi Children [NA]
Completed clinical trial evaluating whether vitamin D can reduce the severity and duration of rotavirus infection in Iraqi children. The stu…
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EMA approval · 2025-12-18EMA Authorised: RotaTeq (rotavirus serotype G1;rotavirus serotype G2;rotavirus serotype G3;rotavirus serotype G4;rotavirus serotype P1) — Merck Sharp & Dohme B.V.
The EMA authorised RotaTeq (pentavalent rotavirus vaccine) by Merck Sharp & Dohme B.V. for immunization against rotavirus infections. This m…
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CLINICAL_TRIALS research · 2025-08-22Clinical Trial Update: PhaseⅡClinical Trial of Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells) [Phase 2]
This entry notes a Phase 2 clinical trial of an oral hexavalent reassortant rotavirus vaccine (attenuated live, Vero cells) by Sinovac Life …
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CLINICAL_TRIALS trial_result · 2025-05-15Clinical Trial Update: Human Challenge With Live-attenuated Rotavirus to Assess Next-generation Rotavirus Vaccines in Africa [Phase 2]
Phase 2 human challenge trial evaluating next-generation live-attenuated rotavirus vaccines in Africa has completed.
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CLINICAL_TRIALS trial_result · 2025-03-18Clinical Trial Update: ROTA-biotic: Measuring the Impact of Rotavirus Vaccines on Paediatric Antibiotic Usage
A completed clinical trial (NCT06882070) evaluated whether rotavirus vaccination reduces antibiotic usage in pediatric patients with rotavir…
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CLINICAL_TRIALS research · 2024-11-20Clinical Trial Update: Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers [Phase 2]
This clinical trial update describes a Phase 2 safety and immunogenicity study of a recombinant trivalent rotavirus subunit vaccine in healt…
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CLINICAL_TRIALS trial_result · 2023-11-29Clinical Trial Update: Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates [Phase 3]
Phase 3 trial update evaluating efficacy, safety, and immunogenicity of the Rotavirus RV3 vaccine (Bio Farma) in neonates for rotavirus gast…
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CLINICAL_TRIALS trial_result · 2023-09-22Clinical Trial Update: Efficacy and Safety of a Pentavalent Rotavirus Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Niger [Phase 3]
Phase 3 trial update on BRV-PV pentavalent rotavirus vaccine assessing efficacy and safety against severe rotavirus gastroenteritis in Niger…
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CLINICAL_TRIALS trial_result · 2023-07-25Clinical Trial Update: The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E [Phase 3]
Phase 3 trial evaluating three doses of live attenuated oral rotavirus vaccine 116E for rotavirus gastroenteritis.
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CLINICAL_TRIALS trial_result · 2023-02-17Clinical Trial Update: Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of RotaTeq® (V260) and Inactivated Poliomyelitis Vaccine in Healthy Chinese Infants (V260-074) [Phase 3]
Phase 3 trial evaluating the immunogenicity and safety of concomitant and non-concomitant administration of RotaTeq (V260) and Inactivated P…
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CLINICAL_TRIALS trial_result · 2021-04-09Clinical Trial Update: A Trial to Assess the Safety, Immunogenicity and Efficacy of a Trivalent Rotavirus P2-VP8 Subunit Vaccine in Prevention of Severe Rotavirus Gastroenteritis in Healthy Infants in Africa and India [Phase 3]
A Phase 3 trial evaluating safety, immunogenicity, and efficacy of a trivalent rotavirus P2-VP8 subunit vaccine in healthy infants in Africa…
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CLINICAL_TRIALS trial_result · 2021-03-29Clinical Trial Update: To Determine the Safety and Efficacy of Liquid ROTAVAC 5C Vaccine Against Childhood Diarrhea Caused by Rotavirus [Phase 3]
Phase 3 trial update evaluating safety and efficacy of Liquid ROTAVAC 5C vaccine for childhood diarrhea caused by rotavirus has been complet…
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CLINICAL_TRIALS trial_result · 2020-10-23Clinical Trial Update: Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac in Healthy Infants in Vietnam [Phase 3]
Phase 3 trial update evaluating immunogenicity, safety, and reactogenicity of Rotavac in healthy infants in Vietnam for rotavirus gastroente…
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CLINICAL_TRIALS trial_result · 2019-10-04Clinical Trial Update: Enteroadsorbent Polymethylsiloxane vs Probiotic Lactobacillus Reuteri in the Treatment of Rotaviral Gastroenteritis [Phase 4]
Phase 4 trial comparing an enteroadsorbent (polymethylsiloxane) vs a probiotic (Lactobacillus reuteri) for rotaviral gastroenteritis; study …
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CLINICAL_TRIALS trial_result · 2019-01-25Clinical Trial Update: Safety Study of GSK Biologicals' Rotavirus Vaccine (Rotarix®) Administered to Children Aged <1 Year in the United States
This document reports the completion and posting of results for a safety study of the Rotarix rotavirus vaccine administered to children und…
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CLINICAL_TRIALS trial_result · 2018-09-11Clinical Trial Update: Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization [Phase 3]
Phase III trial evaluating lot-to-lot consistency of a rotavirus vaccine and its interference with routine UIP immunization has completed.
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CLINICAL_TRIALS trial_result · 2018-09-10Clinical Trial Update: Study on Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) to Evaluate Lot-to-Lot Consistency and to Compare Non-Inferiority With ROTASIIL (Lyophilized BRV-PV) in Healthy Infants in India [Phase 2, Phase 3]
A completed Phase 2/Phase 3 trial evaluating lot-to-lot consistency and non-inferiority of Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV…
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CLINICAL_TRIALS trial_result · 2018-09-10Clinical Trial Update: A Clinical Trial to Study the Effect and Safety of Rotavirus Vaccine Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants [Phase 3]
Phase 3 trial assessing the efficacy and safety of a rotavirus vaccine in healthy Indian infants with completed results.
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CLINICAL_TRIALS research · 2018-06-18Clinical Trial Update: Hospital-based Surveillance of Rotavirus Gastroenteritis in Young Taiwanese Children
This completed hospital-based surveillance study examined rotavirus gastroenteritis in young Taiwanese children.
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CLINICAL_TRIALS trial_result · 2017-12-13Clinical Trial Update: Phase I/II Descending Age Study of P2VP8 Subunit Parenteral Rotavirus Vaccine in Healthy Toddlers and Infants [Phase 1, Phase 2]
This document reports results from a Phase I/II descending-age study of a P2VP8 subunit parenteral rotavirus vaccine in healthy toddlers and…
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CLINICAL_TRIALS trial_result · 2017-08-21Clinical Trial Update: Safety, Reactogenicity and Immunogenicity of Heat-stable Rotavirus Vaccine (HSRV) in Adults and Infants [Phase 1, Phase 2]
Phase 1/2 clinical trial update reporting on the safety, reactogenicity, and immunogenicity of the Heat-stable Rotavirus Vaccine (HSRV) in a…
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CLINICAL_TRIALS trial_result · 2017-06-07Clinical Trial Update: Impact of Rotavirus Vaccination on Hospitalisations for Rotavirus Gastroenteritis in Children Aged <5 Years in Australia
This update reports the results of a completed trial assessing whether rotavirus vaccination reduced hospitalizations for rotavirus gastroen…