Home > Result Summaries: Compounds > Rotavirus Vaccine Result Summaries: Rotavirus Vaccine GSKStudy ID Phase Title Summary (Download) 101555 Phase 2 A phase II, double-blind, randomized, placebo-controlled study to compare the immunogenicity, reactogenicity and safety of 2 different formulations of GSK Bios’ live attenuated human rotavirus (HRV) vaccine given as a two-dose primary vaccination in healthy infants previously uninfected with HRV (0 citation(s)) 102247/036 phase 3 A multi-country & multi-center study to assess the efficacy, safety & immunogenicity of 2 doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants in co-administration with specific childhood vaccines (13 citation(s)) 102247/036 Annex Phase 3 A phase IIIb, double-blind, randomized, placebo-controlled, multi-country study to assess the efficacy, safety and immunogenicity of two doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants in co-administration with specific childhood vaccinations. (5 citation(s)) 102248 phase 3 Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants (11 citation(s)) 103366 phase 4 Open, multicentric, post-marketing surveillance study to evaluate safety and reactogenicity of GSK Bio's live attenuated oral Human Rotavirus (HRV) vaccine, Rotarix when administered according to Prescribing Information, in Filipino subjects aged at least 6 weeks of age at the time of first vaccination (0 citation(s)) 103477 phase 3 Study to asses the immunogenicity, reactogenicity and safety of GlaxoSmithKline Biologicals’ oral live attenuated human rotavirus (HRV) vaccine following a 0, 2 month schedule, in healthy infants previously uninfected with human rotavirus. (7 citation(s)) 103478 Phase 3 Assess the immunogenicity, safety & reactogenicity of 2 doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants (6-12 weeks of age at first dose) previously uninfected with human rotavirus (2 citation(s)) 103792 Phase 3 A multicenter study of the immunogenicity & safety of 2 doses of GSK Biologicals’ oral live attenuated human rotavirus vaccine (RIX4414) as primary dosing of healthy infants in India aged approximately 8 wks at the time of the first dose (3 citation(s)) 103992 Phase 2 Evaluate immunogenicity, reactogenicity & safety of 2 doses of GSK Biologicals’ oral live attenuated HRV vaccine (RIX4414 at 106.5 CCID50) when given concomitantly with OPV versus given alone (HRV vaccine dose given 15 days after the OPV dose) in healthy infants in Bangladesh (3 citation(s)) 104435 phase 4 Post-Authorization Safety Study (PASS) of Post-Marketing Surveillance for Intussusception following Rotarix™ introduction into the Instituto Mexicano del Seguro Social (IMSS) in Mexico (2 citation(s)) 104480 phase 2 Compare the immunogenicity, reactogenicity & safety of 2 different formulations of GSK Biologicals’ live attenuated human rotavirus (HRV) vaccine given as a two-dose primary vaccination in healthy infants previously uninfected with HRV (3 citation(s)) 104676 Phase 4 Hospital-based, case-control study to assess the vaccine effectiveness of Rotarix™ against rotavirus severe gastroenteritis (RV SGE) among hospitalised children born after 1 March 2006 and at least 12 weeks of age, in Panama (0 citation(s)) 105722 phase 3 A placebo-controlled study to evaluate the immunogenicity, reactogenicity and safety of two doses of GSK Bio oral live attenuated human rotavirus (HRV) liquid vaccine, when given to healthy infants, in Vietnam (2 citation(s)) 106260 phase 3 A Phase IIIb, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family. (2 citation(s)) 106481 phase 3 Phase IIIb, Double Blind, Randomised, Placebo-Controlled, Multi-Country/Centre, Study to Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Pre-Term Infants (3 citation(s)) 107017 phase 3 Multicentre study to assess the effect of prophylactic antipyretic treatment on the rate of febrile reactions following concomitant administration of GSK Biologicals’ 10-valent pneumococcal conjugate, Infanrix hexa and Rotarix vaccines (5 citation(s)) 107077 phase 3 A study to assess the immunogenicity, reactogenicity and safety of 2 different formulations of GSK Bio live attenuated HRV vaccine, given as a two-dose primary vaccination, in healthy infants previously uninfected with HRV (1 citation(s)) 107531 phase 3 Assess the immunogenicity of 3 doses of Pediarix®, Prevnar® & ActHIB® given to healthy infants when administered with GSK Biologicals’ 2 dose oral live attenuated human rotavirus vaccine given during the same vaccination visit or separately (1 citation(s)) 107625 phase 3 Efficacy, safety, reactogenicity and immunogenicity study of the lyophilised formulation of Rotarix vaccine in healthy Japanese infants (3 citation(s)) 107876 Phase 3 Study to evaluate clinical consistency of the liquid formulation of GSK Biologicals' HRV vaccine and to evaluate liquid formulation compared to lyophilised formulation of the HRV vaccine administered as a two-dose primary vaccination. (1 citation(s)) 109216 phase 2 Immunogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) liquid vaccine (GSK 357941A) in healthy infants. (1 citation(s)) 109661_ phase 3 Primary vaccination course in children receiving the pneumococcal vaccine GSK 1024850A, Infanrix hexa and Rotarix (4 citation(s)) 109810 phase 3 To assess long-term efficacy & safety of subjects approximately 3 years after priming with 2 doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine (Rotarix) in the primary vaccination study (102247). (0 citation(s)) 109861 phase 3 Primary vaccination course in children receiving the pneumococcal vaccine GSK 1024850A, Infanrix hexa and Rotarix (5 citation(s)) 110467 n\a Case-control study to evaluate the vaccine effectiveness of Rotarix™ against rotavirus severe gastroenteritis (RV SGE) among hospitalised children < 5 years of age in KK Hospital, Singapore (1 citation(s)) 111426 phase 4 Case-control Study to Evaluate the Vaccine Effectiveness of GlaxoSmithKline (GSK) Biologicals' Live Attenuated Human Rotavirus (HRV) Vaccine (Rotarix™) Against Community-acquired Rotavirus Severe Gastroenteritis (RV SGE) Among Hospitalised Children Born After 1 October 2006, in Belgium (3 citation(s)) 111562 phase 4 Case-control Study to Evaluate the Vaccine Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) Among Hospitalized Children Born After 6 March 2006 and at Least 12 Weeks of Age, in Belem, Brazil (1 citation(s)) 111634_1 phase 3 Primary and booster vaccination course in human immunodeficiency virus (HIV) infected infants, HIV exposed uninfected infants and unexposed uninfected infants receiving the pneumococcal vaccine GSK 1024850A. (3 citation(s)) 111654_ phase 3 Non-inferiority of a commercial lot of the pneumococcal vaccine GSK1024850A compared to a clinical lot. (1 citation(s)) 111664 phase 4 Reactogenicity and safety of two doses of GSK Biologicals’ oral live attenuated human rotavirus vaccine, Rotarix™ when administered in Sri Lankan infants aged at least 6 weeks at the time of first vaccination. (1 citation(s)) 111700 phase 4 Safety of GlaxoSmithKline Biologicals’ oral live attenuated human rotavirus vaccine, Rotarix™ or Rotarix™ liquid formulation (oral suspension or prefilled syringe) when administered according to the prescribing information in Korea (0 citation(s)) 111757 phase 4 Time Trend Analysis of Diarrhoea-related Incidence, Hospitalizations, and Deaths in Children < 5 Years of Age in Panama by Monitoring Secondary Data Sources From 1990-2010 (1 citation(s)) 112269 phase 4 Immunogenicity, reactogenicity and safety study to evaluate two doses of the lyophilised formulation of the human rotavirus (HRV) vaccine when administered to healthy Korean infants previously uninfected with HRV (2 citation(s)) 112368 n\a Time trend analysis of diarrhea-related hospitalizations and deaths in children < 5 years of age in Brazil, 1990-2010 (3 citation(s)) 112896 phase 4 Post marketing surveillance to monitor the reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus vaccine, Rotarix™ when administered according to the Prescribing Information to Indian infants (2 citation(s)) 113266_1 phase 3 Evaluation of immunological persistence following 3-dose priming with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine in study NCT00808444 and safety and immunogenicity following a booster dose of the same vaccine (0 citation(s)) 113518 phase 1 Reactogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated liquid human rotavirus (HRV) vaccine 444563, in healthy infants (0 citation(s)) 113545 phase 1 Reactogenicity and safety of a single dose of GlaxoSmithKline (GSK) Biologicals’ human rotavirus (HRV) vaccine (444563) in healthy adults (0 citation(s)) 113552 phase 1 Reactogenicity and safety of a single dose of GlaxoSmithKline (GSK) Biologicals’ human rotavirus (HRV) vaccine (444563) in healthy children (0 citation(s)) 113808 phase 3 Efficacy, Immunogenicity and Safety of Two Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Liquid Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants (0 citation(s)) 114351 phase 4 Immunogenicity, reactogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy Taiwanese infants who received hepatitis B immunoglobulin after birth. (0 citation(s)) 114444 n\a Blinded retrospective laboratory evaluations to assess the serologic response to Porcine circovirus type 1 (PCV-1) and PCV-1 DNA in the stool of infants aged 6 to 12 weeks following administration of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus vaccine (444563) (0 citation(s)) 114910 n\a A study on the impact of rotavirus vaccination on hospitalisations for rotavirus gastroenteritis in children aged <5 years in Australia (1 citation(s)) 444563/001 Phase 1 A phase I, double-blind, randomized, placebo-controlled study of the safety and reactogenicity of a single oral dose of the SB Biologicals’ live attenuated human rotavirus (HRV) vaccine in healthy adults aged 18 to 45 years. (7 citation(s)) 444563/002 Phase 1 A phase I, double-blind, randomized, placebo-controlled study of the safety and reactogenicity of GSK Bios’ live attenuated human rotavirus vaccine at 2 different virus concentrations in healthy seropositive children between 1 and 3 years of age, when given as a single oral administration (7 citation(s)) 444563/003 phase 2 A phase II, double-blind, randomized, placebo-controlled, dose-escalating, stepwise study to assess safety, reactogenicity and immunogenicity of GlaxoSmithKline Biologicals’ live attenuated human rotavirus (HRV) vaccine in healthy infants previously uninfected with human rotavirus. (8 citation(s)) 444563/004 Phase 2 A study to assess the efficacy, immunogenicity and safety of two doses of oral live attenuated human rotavirus (HRV) vaccine (Rotarix) in healthy infants. (8 citation(s)) 444563/004 Annex Phase 2 A phase IIb, double-blind, randomized, placebo-controlled study to assess the efficacy, immunogenicity, reactogenicity and safety of two doses of GSK Biologicals oral live attenuated human rotavirus (HRV) vaccine in healthy infants approximately 2 months of age and previously uninfected with HRV (5 citation(s)) 444563/005 Phase 2 Phase II, double-blind, randomized, placebo-controlled study of 2 doses of GSK Bios’ live attenuated human rotavirus vaccine at different virus concentrations (10 5.2 and 10 6.4 ffu) in healthy infants following a 0, 2 month schedule and previously uninfected with human rotavirus (5 citation(s)) 444563/006 Phase 2 To assess the efficacy, immuno & safety of 2 doses of GSK HRV vaccine at different virus concentrations in healthy infants aged 2 months & previously uninfected with HRV, concurrently given with DTPw-HBV, Hib. (13 citation(s)) 444563/006 Annex Phase 2 A study to assess efficacy, immunogenicity, reactogenicity and safety of two doses of GSK Bio’s live attenuated human rotavirus vaccine at different virus concentrations in healthy infants and previously uninfected with HRV, when administered concurrently with DTPw-HBV and Hib vaccines (1 citation(s)) 444563/013 phase 2 A phase II, randomized, double-blind, placebo-controlled study of safety, reactogenicity and immunogenicity of 2 or 3 doses of GSK Bios’ oral live attenuated human rotavirus vaccine at 106.5 CCID50 viral concentration in healthy infants (approximately 5-10 weeks old) in the Republic of South Africa (3 citation(s)) 444563/014 Phase 2 Study of safety, reactogenicity and immunogenicity of two doses of GSK Bio’s oral live attenuated human rotavirus vaccine co-administered with either oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in healthy infants in South Africa (2 citation(s)) 444563/021 Phase 2 Phase II, double-blind, randomized, placebo-controlled clinical study to assess immunogenicity and reactogenicity of doses of a modified vaccine formulation versus GSK Bios’ live attenuated human rotavirus vaccine when orally administered to healthy infants at 2, 4 and 6 months of age (0 citation(s)) 444563/022 phase 2 Assess the Safety, Reactogenicity and Immunogenicity of 3 Doses of GSK Biologicals' HRV Vaccine Administered to HIV Infected Infants at 6, 10 and 14 Weeks of Age in South Africa (2 citation(s)) 444563/023 phase 3 A placebo-controlled, multi-country & multi-center study to assess the efficacy, safety & immunogenicity of 2 doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants (8 citation(s)) 444563/023(2) Phase 3 A phase III, double-blind, randomized, placebo-controlled, multi-country and multi-centre study to assess the efficacy, safety and immunogenicity of two doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants. (7 citation(s)) 444563/023(3) Phase 3 A phase III, double-blind, randomized, placebo-controlled, multi-country and multi-center study to assess the efficacy, safety and immunogenicity of two doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants. (3 citation(s)) 444563/024 phase 3 A multi-country & multi-center study to assess the efficacy, immunogenicity & safety of two doses of GSK Biologicals' oral live attenuated HRV vaccine given concomitantly with routine EPI vaccinations including OPV in healthy infants (4 citation(s)) 444563/028/029/030 phase 3 A phase III, double-blind, randomized, placebo-controlled, multi-country and multi-center study to assess the efficacy and safety of two doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants (7 citation(s)) 444563/033 phase 3 Study to assess the clinical consistency of three production lots of GSK Biologicals’ HRV vaccine in terms of immunogenicity and safety when given to healthy infants at 2 and 4 months of age (1 citation(s)) 999910/193 n\a Prospective, Hospital-based, Multicentre Study to Assess the Incidence of Intussusception in Children < 2 Years of Age in Singapore (0 citation(s))
