GlaxoSmithKline: Rotavirus Infections trials

The registry lists 61 Rotavirus Infections studies with GlaxoSmithKline as lead sponsor. 0 are open to participants now and 21 have results posted.

Phase 1 3Phase 2 10Phase 3 23Phase 4 2No phase 23(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 WeeksCompletedNCT03954743Phase 3Results posted
• 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 VaccineCompletedNCT03207750Phase 3Results posted
• Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 WeeksCompletedNCT02914184Phase 3Results posted
• Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.CompletedNCT01198769Phase 4Results posted
• Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese InfantsCompletedNCT01171963Phase 3Results posted
• Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean InfantsCompletedNCT00969228Phase 4Results posted
• Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian InfantsCompletedNCT00938327Results posted
• Safety Study of GSK Biologicals' Rotavirus Vaccine (Rotarix®) Administered to Children Aged <1 Year in the United StatesCompletedNCT00875641Results posted
• Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in InfantsCompletedNCT00779779Results posted
• Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in InfantsCompletedNCT00750893Results posted
• Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of AgeCompletedNCT00533507Phase 3Results posted
• Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese InfantsCompletedNCT00480324Phase 3Results posted
• A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants.CompletedNCT00432380Phase 2Results posted
• To Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK's Oral Human Rotavirus Vaccine in Pre-Term InfantsCompletedNCT00420745Phase 3Results posted
• Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.CompletedNCT00420316Phase 3Results posted
• A Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.CompletedNCT00396630Phase 3Results posted
• To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)CompletedNCT00363545Phase 3Results posted
• To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First VaccinationCompletedNCT00353366Results posted
• Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210)CompletedNCT00329745Phase 3Results posted
• A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South AfricaCompletedNCT00263666Phase 2Results posted
• Vaccine Efficacy Against Rotavirus Diarrhea; Vaccine Given With Routine Childhood Vaccinations in Healthy African InfantsCompletedNCT00241644Phase 3Results posted
• Serologic Response to Porcine Circovirus Type 1 (PCV-1) in Infants Following Administration of Rotarix™CompletedNCT02153333
• Effectiveness of RotarixTM Vaccine in Children Aged Between 12 Weeks to < 5 Years, Hospitalised for Severe GastroenteritisWithdrawnNCT01978223
• Study to Analyze the Clinical and Cost Impact of Complete and Incomplete Rotarix VaccinationCompletedNCT01915888
• Study to Assess the Impact of Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus GastroenteritisCompletedNCT01733862
• A Study to Estimate the Occurrence of Rotavirus Gastroenteritis in Children < 5 Years of Age, in Bulgaria and LatviaCompletedNCT01733849
• Study to Analyze the Clinical and Cost Impact of Complete and Incomplete Rotavirus (RV) VaccinationCompletedNCT01682005
• Special Drug Use Investigation for ROTARIX®CompletedNCT01636739
• Drug Use Investigation for ROTARIX®CompletedNCT01636193
• Impact on Quality of Hospital Care During Pre- and Post- Rotavirus (RV) Vaccination Introduction in BelgiumCompletedNCT01592838
• Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2010-2011CompletedNCT01563159
• Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2006-2007CompletedNCT01563146
• Serological Response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in Stools of Infants Following Administration of Rotarix™CompletedNCT01511133
• Observational Study on Rotavirus Gastroenteritis Epidemiology, Impact of Lyophilised vs. Liquid Formulation of Rotarix™CompletedNCT01435967
• Epidemiological, Observational and Post Marketing Study of Rotarix™ in Children With Severe Gastroenteritis in BelgiumCompletedNCT01339221
• Surveillance Study to Estimate the Proportion of Rotavirus Gastroenteritis in Children < 5 Years of Age in RomaniaCompletedNCT01253967
• Effectiveness Study of GSK Biologicals' Rotarix TM Vaccine in Hospitalized ChildrenCompletedNCT01177826
• Study to Evaluate the Reactogenicity and Safety of Rotarix™ in Chinese AdultsCompletedNCT01162590Phase 1
• Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 VaccineWithdrawnNCT01110044Phase 2
• Study to Assess the Safety of GSK Biologicals' Liquid Human Rotavirus Vaccine in Healthy InfantsCompletedNCT01107587Phase 1
• Study to Evaluate the Safety of Rotarix™ in Chinese ChildrenCompletedNCT01086436Phase 1
• Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV VaccineCompletedNCT00757770Phase 3
• Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.CompletedNCT00729001Phase 2
• Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants in PanamaCompletedNCT00653198
• Hospital-based Surveillance to Collect Prospective Data to Estimate the Disease Burden of Severe RV GE in SwedenCompletedNCT00489567
• Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine in Healthy InfantsCompletedNCT00425737Phase 2
• Evaluate Protective Efficacy of Diff Strengths of Human Rotavirus Vaccine After Admn of 2 Doses to Infants Aged 2 MonthsCompletedNCT00385320Phase 2
• Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South AfricaCompletedNCT00383903Phase 2
• A Study in Infants to Test Two Preparations (Freeze-dried or Liquid) of the Rotavirus Vaccine (HRV Vaccine).CompletedNCT00382772Phase 3
• Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant VaccinesCompletedNCT00370318Phase 3
• To Evaluate 2 Doses of GSK Biologicals' Oral Live Attenuated Human HRV Vaccine Co-administered With Either OPV or IPVCompletedNCT00346892Phase 2
• To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)CompletedNCT00345956Phase 3
• Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USACompletedNCT00334607Phase 3
• Assess the Immunogenicity & Safety of 2 Doses of Oral Live Attenuated Human Rota(HRV)Vaccine in Healthy Infants in IndiaCompletedNCT00289172Phase 3
• A Study to Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy InfantsCompletedNCT00197210Phase 3
• To Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood VaccinesCompletedNCT00140686Phase 3
• A Study to Test 2 Doses of the HRV Vaccine in Healthy Infants.CompletedNCT00140673Phase 3
• Study of 2 Doses of HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy InfantsCompletedNCT00139347Phase 3
• A Study to Test 2 Doses of the HRV Vaccine Given With or Without OPV in Healthy Infants in BangladeshCompletedNCT00139334Phase 2
• Study of Immunogenicity & Safety of 2 Different Formulations of Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus GastroenteritisCompletedNCT00137930Phase 2
• Study of 2 Doses of Oral Live Attenuated Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus GastroenteritisCompletedNCT00134732Phase 3