Healthy volunteers
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study. •A male or female child between, and including, 5 and 10 weeks of age at the time of the first study vaccination. •Written informed consent obtained from the parent or guardian of the subject who is of legal age (i.e. parent/guardian should be 18 years or older). (South Africa-specific Amendment 5: 10 July 2006) •Healthy subjects as established by medical history and clinical examination before entering into the study. •In South Africa, birth weight > 2000 g or if weight un-known, gestation period > 36 weeks. Are the trial subjects under 18? yes Number of subjects for this age range: 4941 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 planned use during the study period. •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). •Planned administration of a vaccine not foreseen by the study protocol within 14 days before each dose of study vaccine(s) and ending 14 days after. •Chronic administration (defined as more than 14 days) of immunosuppressants since birth. (Topical steroids are al-lowed.) •History of use of experimental rotavirus vaccine. •Previous routine vaccination except BCG, HBV and OPV vaccination at birth (should be documented in the CRF). (Amendment 1: 24 August 2005) •Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception or other medical condition determined to be serious by the investigator. •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required). •History of allergic disease or reaction likely to be exacer-bated by any component of the vaccine. •Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F) / Axillary temperature <37.5°C (99.5°F) / Rectal temperature <38°C (100.4°F).) (warrants deferral of vaccination). •Gastroenteritis within 7 days preceding the first study vaccine administration (warrants deferral of the vaccina-tion). •Previous cofirmed occurrence of RV GE. •A family history of congenital or hereditary immunodefi-ciency. •Administration of immunoglobulins and/or blood products since birth or planned administration during the study pe-riod. •History of any neurologic disorders or seizures. •Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if the GSK Biologicals' HRV vaccine (pooled HRV groups) given concomitantly with routine EPI vaccinations can prevent severe RV GE (>11 on the 20-point Vesikari scoring system) caused by the circulating wild-type RV strains during the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 6. Criteria: The primary objective will be reached if the lower limit of the 95% CI on vaccine efficacy is >0%. ;Secondary Objective: •To assess efficacy of HRV vaccine given concomitantly with routine EPI vaccinations in terms of -hospitalisation and/or supervised re-hydration therapy in a medical facility for RV GE caused by circulating wild-type RV strains -severe RV GE caused by circulating wild-type RV strains after 3 doses vs 2 doses -severe RV GE (>11 on the 20-point Vesikari scoring system) caused by circulating wild-type RV strains, wild type G1, non-G1 & severe RVGE in for the South African subset of subjects who were fully vaccinated before start of the RV season -Any RV GE caused by circulating wild-type RV strains •To assess safety of 2 or 3 doses of HRV vaccine compared with placebo in terms of AEs leading to drop-out and SAEs •To assess immunogenicity of HRV vaccine in terms of anti-rotavirus IgA antibody seroconversion, seropositivity rate & serum antibody concentrations;Primary end point(s): Occurrence of severe RV GE (score > 11 on a 20-point Vesikari scoring system caused by the circulating wild-type RV strains in pooled HRV groups versus the placebo group. ;Timepoint(s) of evaluation of this end point: During the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Occurrence of hospitalisation and/or supervised re-hydration therapy (equivalent to WHO plan B or C) in a medical facility for RV GE caused by the circulating wild-type RV strains. Occurrence of severe RV GE caused by the circulating wild-type RV strains of G1 serotype. Occurrence of severe RV GE caused by the circulating wild-type RV strains of non-G1 serotype. Occurrence of any and severe RV GE caused by the circulating wild-type RV strains. Occurrence of severe GE. Occurrence of severe RV GE caused by the circulating wild-type RV strains. In South Africa, occurrence of severe RV GE caused by the circulating wild-type RV strains for the subset of subjects who were fully vaccinated before the beginning of the RV season For subjects in Cohort 2 South Africa and the cohort in Malawi: Occurrence of severe RV GE (score >= 11 on a 20-point Vesikari scoring system caused by the circulating wild-type RV strains Occurrence of hospitalisation and/or supervised re-hydration therapy (equivalent to WHO plan B or C) in a medical facility for RV GE caused by the circulating wild-type RV strains Occurrence of severe RV GE caused by the circulating wild-type RV strains of G1 serotype. Occurrence of severe RV GE caused by the circulating wild-type RV strains of non-G1 serotype For all subjects, occurrence of AEs/SAEs leading to drop-out In a subset of subjects, seroconversion rate and Geometric Mean concentration (GMC) to anti-rotavirus IgA antibody In all subjects, seropositivity rate and GMC to anti-rotavirus IgA antibody ;Timepoint(s) of evaluation of this end point: RV GE and Hospitalisation: During the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 6. Severe RV GE: During the period starting from Dose 1 of the study vaccine until Visit 6. South Africa: During the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 6 Cohort 2: During the period from 2 weeks after the last | — |
Countries
Malawi, South Africa
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed