Rotavirus Infection
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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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CLINICAL_TRIALS trial_result · 2026-01-26Clinical Trial Update: Effectiveness of Monovalent Rotavirus Vaccine (RV1)
Clinical trial update reporting the effectiveness of the monovalent rotavirus vaccine RV1 (Rotarix) in preventing rotavirus infection and re…
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CLINICAL_TRIALS trial_result · 2025-09-22Clinical Trial Update: Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand [Phase 3]
Phase 3 study evaluating the DTwP-HepB-Hib-IPV (SHAN6) vaccine administered with routine vaccines in healthy infants and toddlers in Thailan…
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CLINICAL_TRIALS trial_result · 2025-05-22Clinical Trial Update: The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants [Phase 3]
Phase 3 study evaluating the efficacy of the oral Rotavirus vaccine ROTAVAC 5D (116E) in Chilean infants.
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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 · 2022-11-14Clinical Trial Update: Response to Rotavirus Vaccine in Infants in Ho Chi Minh City in Vietnam [Phase 4]
Phase 4 clinical trial update evaluating response to rotavirus vaccine in infants in Ho Chi Minh City, Vietnam.
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CLINICAL_TRIALS trial_result · 2021-09-05Clinical Trial Update: Reactogenicity, Safety and Immunological Efficacy of the Live, Pentavalent Rotavirus Vaccine in Childhood Immunization [Phase 3]
A Phase 3 trial updating reactogenicity, safety, and immunological efficacy of a live pentavalent rotavirus vaccine in childhood immunizatio…
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CLINICAL_TRIALS trial_result · 2020-12-19Clinical Trial Update: Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia [Phase 2, Phase 3]
Phase 2/3 trial update for BBIL's ROTAVAC vaccines in Zambia; study completed with results posted in 2020.
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CLINICAL_TRIALS trial_result · 2020-12-09Clinical Trial Update: Immunogenicity, Reactogenicity and Safety Study of Two Different Formulations of GSK Biologicals' Human Rotavirus Vaccine, Rotarix, in Healthy Infants [Phase 3]
Phase 3 immunogenicity, reactogenicity and safety study comparing two Rotarix formulations in healthy infants has completed with results pos…
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CLINICAL_TRIALS trial_result · 2020-07-17Clinical Trial Update: The Effects of Increased Inoculum on Oral Rotavirus Vaccine Take and Immunogenicity [Phase 4]
Phase 4 clinical trial evaluating how increased inoculum affects oral rotavirus vaccine take, immunogenicity, and shedding.
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CLINICAL_TRIALS trial_result · 2019-12-30Clinical Trial Update: A Study to Test 2 Doses of the HRV Vaccine in Healthy Infants. [Phase 3]
Study investigating two doses of the HRV vaccine in healthy infants (Phase 3) has completed.
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CLINICAL_TRIALS trial_result · 2019-10-31Clinical Trial Update: This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine [Phase 3]
Phase 3 trial evaluating immunogenicity, reactogenicity, and safety of co-administered routine infant vaccines with GSK's liquid HRV compare…
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CLINICAL_TRIALS trial_result · 2019-03-25Clinical Trial Update: Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® in Healthy Infants Aged Between 6-8 Weeks in Vietnam [Phase 3]
A Phase 3 trial evaluating immunogenicity, safety, and reactogenicity of Rotavac in healthy infants aged 6-8 weeks in Vietnam.
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CLINICAL_TRIALS trial_result · 2019-02-18Clinical Trial Update: Coadministration of Measles-rubella and Rotavirus Vaccines [Phase 4]
Phase 4 trial update evaluating coadministration of measles-rubella and rotavirus vaccines with results completed and posted in 2019.
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CLINICAL_TRIALS trial_result · 2019-02-15Clinical Trial Update: A Phase 1 Dose Escalation Study to Examine the Safety of the P2-VP8 Rotavirus Vaccine [Phase 1]
Phase 1 dose-escalation study assessing safety of the P2-VP8 Rotavirus vaccine; completed with results posted.
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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 · 2019-01-23Clinical Trial Update: Evaluation of Immunogenicity and Safety of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus (DPT-IPV) Vaccine Squarekids Co-administered With GSK Biologicals' Human Rotavirus (HRV) Vaccine Rotarix (GSK444563) in Healthy Infants [Phase 4]
Phase 4 trial evaluating immunogenicity and safety of co-administering the DPT-IPV vaccine with Rotarix in healthy infants; study completed …
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CLINICAL_TRIALS trial_result · 2018-08-08Clinical Trial Update: Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between RV5 and RV1 Using Seven Combined Anti-rotavirus Prevention Programs [Phase 3]
Phase 3 randomized, single-blind study assessing interchangeability between two rotavirus vaccines (RV5 and RV1) across seven prevention pro…
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CLINICAL_TRIALS trial_result · 2018-07-12Clinical Trial Update: Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study [Phase 4]
Phase 4 pilot study investigating potential mechanisms for intussusception after rotavirus vaccination; results were posted in 2018.
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CLINICAL_TRIALS trial_result · 2018-06-20Clinical Trial Update: RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016) [Phase 3]
Phase 3 trial results for a combination vaccine regimen including RotaTeq and Meningococcus C vaccine in healthy infants; results were poste…
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CLINICAL_TRIALS trial_result · 2018-03-12Clinical Trial Update: Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2006-2007
The completed trial update reports on the number of rotavirus-related hospitalizations in Belgium during the 2006-2007 season, sponsored by …
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CLINICAL_TRIALS trial_result · 2017-07-25Clinical Trial Update: The Role of the Intestinal Microbiome in Enteric and Systemic Vaccine Immune Responses [NA]
A completed clinical trial examining how the intestinal microbiome influences immune responses to enteric and systemic vaccines, including r…
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CLINICAL_TRIALS trial_result · 2017-05-30Clinical Trial Update: Assess the Immunogenicity & Safety of 2 Doses of Oral Live Attenuated Human Rota(HRV)Vaccine in Healthy Infants in India [Phase 3]
Phase 3 trial assessing immunogenicity and safety of two doses of an oral live attenuated rotavirus vaccine in healthy Indian infants; the s…
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CLINICAL_TRIALS trial_result · 2017-05-16Clinical Trial Update: Serological Response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in Stools of Infants Following Administration of Rotarix™
This completed clinical trial evaluated serological response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in the stools of infants aft…
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CLINICAL_TRIALS trial_result · 2017-03-23Clinical Trial Update: To Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines [Phase 3]
A Phase 3 trial evaluated two doses of GSK's oral live attenuated human rotavirus vaccine in healthy infants when co-administered with certa…