Rotavirus gastroenteritis
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Subjects who the investigator believed that their parents/guardians could and would comply with the requirements of the protocol -A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination according to the country recommendations for the routine vaccination schedules. -Written informed consent obtained from the parent or guardian of the subject, prior any study procedure. -Free of obvious health problems as established by medical history and clinical examination before entering into the study. Are the trial subjects under 18? yes Number of subjects for this age range: 6568 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine or placebo, or planned use during the study period. -Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. -Child was unlikely to remain in the study area for the duration of the study. -Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. -History of allergic disease or reaction likely to be exacerbated by any component of the vaccine. -Administration of immunoglobulins and/or blood products since birth or planned administration during the study pe-riod. -Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if two doses of GSK Biologicals’ HRV vaccine given concomitantly with routine EPI vaccinations including OPV can prevent severe RV GE caused by the circulating wild-type RV strains during the period starting from 2 weeks after Dose 2 until one year of age.;Secondary Objective: To assess if severe RVGE can be prevented by HRV vaccine, caused by wild RV strain serotype G1, non-G1 serotypes and due to each non-G1 during the period starting from 2 weeks after Dose 2 until 1 year of age. To assess severe RVGE can be prevented by HRV vaccine after 1st dose. To assess safety (SAEs) throughout the study period. In a subset of 300 subjects, to explore the effect of HRV vaccine on immune response to concurrently administered routine EPI vaccinations and to assess immunogenicity of anti-RV IgA antibody concentrations 1 to 2 months after the 2nd dose. In a subset of 900 subjects, to demonstrate NI of HRV over placebo group in terms of immune response to concurrently administered OPV, 1 month after Dose 3 in a subset with no OPV given in neonatal period and to explore the effect of HRV vaccine on immune response, 1 month after Dose 1 and 2 of OPV in a subset with no OPV given in neonatal period and after Dose 1, 2 and 3 in a subset with OPV given in neonatal period.;Primary end point(s): Occurrence of severe RV GE caused by the wild RV strains ;Timepoint(s) of evaluation of this end point: 2 weeks after Dose 2 until the infant turns one year of age | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Occurrence of severe RV GE caused by the wild RV strain of serotype G1. Occurrence of severe RV GE due to non-G1 serotypes Occurrence of severe RV GE due to each non-G1 serotype Occurrence of severe RV GE caused by the circulating wild RV strains, of severe RV GE caused by the wild RV strain of serotype G1, of severe RV GE due to non-G1 serotypes and of severe RV GE due to each non-G1 serotype Safety endpoint Occurrence of SAEs Immunogenicity endpoints In a subset of 300 subjects: Serum rotavirus IgA antibody concentrations GMTs for anti-polio type 1, 2 and 3 antibodies. Seroprotection status: anti-poliovirus serotype 1, 2 and 3 antibody titre greater than or equal to 8 One to two months after the third dose of routine EPI vaccinations (at Visit 4): Geometric mean antibody concentrations (GMC)/geometric mean antibody titres (GMT) for anti-PRP, anti-diphtheria and anti-tetanus, anti-BPT, anti- poliovirus serotypes 1, 2 and 3, and anti-HBsAg antibodies. Seroprotection status: anti-PRP antibody concentration greater than or equal to 0.15 and 1.0 mcg/ml anti-diphtheria toxoid antibody concentration greater than or equal to 0.1 IU/ml anti-tetanus toxoid antibody concentration greater than or equal to 0.1 IU/ml anti-HBsAg antibody concentration greater than or equal to 10.0 mIU/ml anti-poliovirus serotype 1, 2 and 3 antibody titre greater than or equal to 8 Seropositivity status: anti-BPT antibody concentrations greater than or equal to 15 EL.U/ml In a subset of 900 subjects: GMTs for anti-polio type 1, 2 and 3 antibodies Seroprotection status: anti-poliovirus serotype 1, 2 and 3 antibody titre greater than or equal to 8;Timepoint(s) of evaluation of this end point: RV GE caused by wild RV strain of serotype G1, non-G1 and each non-G1 and circulating wild RV strains, serotype G1, non-G1 and each non-G1 serotype: 2 weeks after Dose 2 until the infant turns 1 year of age and from Day 0 until the infant turns 1 yea | — |
Countries
Argentina, Brazil, Colombia, Dominican Republic, Honduras, Panama
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed