Vaccine Rotavirus has been approved in the European Union and in the Other Countries

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

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Vaccine Rotavirus studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
102247 (rota-036 annex) Note: This summary presents results for the second and combined efficacy periods. Results from the first efficacy period are presented in 102247 (rota-036) CTRS. III A phase IIIb, double-blind, randomized, placebo-controlled, multi-country and multi-center 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.
102247 (rota-036) III A phase IIIb, double-blind, randomized, placebo-controlled, multi-country and multi-center 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.
103477 (rota-039) III A phase IIIb, partially blind, randomized, placebo-controlled study to asses the effect on immunogenicity of administration of vaccine without buffering agent and to assess heat stability in terms of 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.
103478 (rota-041) III A phase IIIb, double-blind, randomized, placebo-controlled, multicentre study to assess the immunogenicity, safety and reactogenicity of 2 doses of GlaxoSmithKline (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.
103792 (rota-044) III A phase IIIb, randomised, multicentre double-blind, placebo-controlled study of the immunogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine (RIX4414) as primary dosing in healthy infants in India of approximately 8 weeks of age at the first dose.
107077 (Rota-057) III A phase III, open, randomized study to assess the immunogenicity, reactogenicity and safety of two different formulations of GlaxoSmithKline (GSK) Biologicals’ live attenuated human rotavirus (HRV) vaccine, given as a two-dose primary vaccination, in healthy infants previously uninfected with HRV.
107876 (Rota-061) III A phase III, randomised study to evaluate the clinical consistency in terms of immunogenicity and reactogenicity of three production lots of the liquid formulation of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine and to evaluate the liquid formulation as compared to the lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose primary vaccination in healthy infants previously uninfected with human rotavirus. Rotarix: GSK Biologicals’ HRV vaccine
109810 (ROTA-036 EXT Y3) III A phase IIIb open study to assess the long-term efficacy and safety of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine approximately three years after vaccination in healthy infants aged 6-12 weeks at the time of first vaccination in the Rota-036 study (eTrack No.102247) in Finland.
444563/024 (rota-024) III A phase III, double-blind, randomized, placebo-controlled, multi-country and multi-center study to assess the efficacy, immunogenicity and safety of two doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine given concomitantly with routine EPI vaccinations including OPV in healthy infants. Rotarix: GlaxoSmithKline (GSK) Biologicals’ HRV vaccine EPI: Expanded program of immunization; OPV: oral polio vaccine.
444563/033 (rota-033) III A phase III, randomized, double-blind and placebo-controlled 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. HRV: human rotavirus
444563-023 (rota-023) (2nd year efficacy from Visit 4 to Visit 6) III 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. Rotarix®: GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine.
444563-023 (Rota-023) (Efficacy data from Visit 1 to Visit 4) III 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. Rotarix®: GlaxoSmithKline Biologicals’ oral live attenuated human rotavirus (HRV) vaccine
444563-023 (rota-023) (Safety for the period between Visit 1 and Visit 3) III 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. Rotarix®: GlaxoSmithKline Biologicals’ oral live attenuated human rotavirus (HRV) vaccine.
101555 II A phase II, double-blind, randomized, placebo-controlled study to compare the immunogenicity, reactogenicity and safety of 2 different formulations of GlaxoSmithKline (GSK) Biologicals’ live attenuated human rotavirus (HRV) vaccine given as a two-dose primary vaccination in healthy infants previously uninfected with HRV.
104480 II A phase II, double-blind, randomized, placebo controlled study to compare the immunogenicity, reactogenicity and safety of two different formulations of GlaxoSmithKline (GSK) Biologicals’ live attenuated human rotavirus (HRV) vaccine given as a two-dose primary vaccination in healthy infants previously uninfected with HRV.
103992 (rota-045) II A phase II, randomised, double-blind, placebo-controlled study to evaluate the immunogenicity, reactogenicity and safety of two doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine (RIX4414 at 106.5 CCID50) when given concomitantly with OPV versus when given alone (HRV vaccine dose given 15 days after the OPV dose) in healthy infants in Bangladesh. OPV: oral poliovirus vaccine.
105722 (Rota-051) II A phase II, randomized, double-blind, placebo-controlled study to evaluate the immunogenicity, reactogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) liquid vaccine, when given to healthy infants, in Vietnam.
109216 (Rota-063) II A phase II, randomized, double-blind, placebo-controlled study to evaluate the immunogenicity, reactogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) liquid vaccine, when given to healthy infants, in Philippines.
444563/003 (rota 003) II 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
444563/004 (rota 004) Year 1 II 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
444563/004 (rota 004annex) II 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
444563/005 (rota-005) II A phase II, double-blind, randomized, placebo-controlled study of two doses of GlaxoSmithKline Biologicals’ live attenuated human rotavirus (HRV) vaccine at different virus concentrations (10 5.2 and 10 6.4 ffu) in healthy infants (approximately 2 months of age at first dose) following a 0, 2 month schedule and previously uninfected with human rotavirus.
444563/006 (rota-006 Annex) II A phase IIb, double-blind, randomized, placebo-controlled study to assess the efficacy, immunogenicity, reactogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals' live attenuated human rotavirus (HRV) vaccine at different virus concentrations (104.7, 105.2 and 10 5.8 foci forming units [ffu]) in healthy infants (approximately 2 months of age at first dose) following a 0, 2 month schedule and previously uninfected with HRV, when administered concurrently with DTPw-HBV and Hib vaccines. DTPw-HBV: combined diphtheria, tetanus, whole-cell pertussis, hepatitis B vaccine; Hib: Haemophilus influenzae type b vaccine
444563/006 (rota-006) II A phase IIb, double-blind, randomized, placebo-controlled study to assess the efficacy, immunogenicity, reactogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals' live attenuated human rotavirus (HRV) vaccine at different virus concentrations (104.7, 105.2 and 105.8 foci forming units [ffu]) in healthy infants (approximately 2 months of age at first dose) following a 0, 2 month schedule and previously uninfected with HRV, when administered concurrently with DTPw-HBV and Hib vaccines.
444563/007 (rota-007) II A phase IIb, double-blind, randomized, placebo-controlled study to assess the efficacy, immunogenicity, reactogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine at different viral concentrations (104.7, 105.2 and 106.1 foci forming units (ffu)) in healthy infants previously uninfected with human rotavirus and approximately 3 months of age, when administered concurrently with DTPa-IPV/Hib and HBV vaccines. DTPa-IPV/Hib: GSK Biologicals’ combined diphtheria, tetanus, acellular pertussis, inactivated poliovirus and Haemophilus influenzae type b vaccine, HBV: GSK Biologicals’ hepatitis B vaccine.
444563/013 (Rota-013) II A phase II, randomized, double-blind, placebo-controlled study of the safety, reactogenicity and immunogenicity of two or three doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine (RIX4414) at 106.5 CCID50 viral concentration in healthy infants (approximately 5-10 weeks old) in the Republic of South Africa.
444563/014 (Rota-014) II A phase II, double-blind before the 2002 rotavirus season and single blind with respect to OPV after, randomised, placebo-controlled study of the safety, reactogenicity and immunogenicity of two doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine (RIX4414 at 105 ffu) co-administered with either oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in healthy infants (approximately 5 10 weeks old) in South Africa. ffu = foci forming units
444563/020 II A phase II, double-blind randomised, placebo controlled clinical dose-range study to assess the immunogenicity and reactogenicity of an investigational vaccination regimen, and to assess the immunogenicity of OPV orally co-administered to healthy infants at 2, 4 and 6 months of age. OPV: GlaxoSmithKline (GSK) Biologicals’ oral poliovirus vaccine.
444563/021 II A phase II, double-blind, randomized, placebo-controlled clinical study to assess the immunogenicity and reactogenicity of three doses of a modified vaccine formulation versus GlaxoSmithKline (GSK) Biologicals’ live attenuated human rotavirus (HRV) vaccine when orally administered to healthy infants at 2, 4 and 6 months of age.
444563/001 (rota 001) I 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
444563/002 (rota 002) I A phase I, double-blind, randomized, placebo-controlled study of the safety and reactogenicity of GlaxoSmithKline Biologicals’ live attenuated human rotavirus (HRV) vaccine at 2 different virus concentrations in healthy seropositive children between 1 and 3 years of age, when given as a single oral administration