Healthy volunteers (Active immunisation of infants against gastroenteritis (GE) due to rotavirus (RV).)
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, will stay/live in the study area) should be en-rolled in the study. •A male or female between, and including, 6 and 12 weeks (42-90 days) of age in Hong Kong and Taiwan or 11 to 17 weeks (77-125 days) of age in Singapore 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: 10708 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 pre-ceding 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. (Topical steroids are allowed.) •Child is 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 period. Oral intake of immunoglobulins via e.g. breastfeeding is allowed. •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. •First or second degree of consanguinity of parents.
Design outcomes
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-type 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 Occurrence of RV GE caused by the circulating wild-type RV strains and requiring hospitalization and/or rehydration therapy (equivalent to WHO plan B or C) in a medical facility Occurrence of severe RV GE caused by the circulating wild-type RV strains For the LTFU: Occurrence of severe RV GE caused by the wild RV strains. For the LTFU: Occurrence of severe RV GE caused by the wild RV strain of serotype G1 For the LTFU: Occurrence of severe RV GE due to non-G1 serotypes For the LTFU: Occurrence of severe RV GE due to each non-G1 serotype For the LTFU: Occurrence of RV GE caused by the circulating wild-type RV strains and requiring hospitalization and/or rehydration therapy (equivalent to WHO plan B or C) in a medical facility For the LTFU: Occurrence of severe RV GE caused by the circulating wild-type RV strains. For the LTFU: Occurrence of severe GE For all subjects, occurrence of SAEs For all subjects, occurrence of definite IS For all subjects, occurrence of mortality Serum rotavirus IgA antibody titres in all subjects at visits 1 and 3 in a subset of 100 subjects per country.;Timepoint(s) of evaluation of this end point: Severe RV GE: During the period starting from 2 weeks after Dose 2 until two years of age, Severe RV GE caused by the circulating wild-type RV strains: from Dose 1, From one year of age up to two years of age, During the period starting from 2 weeks after Dose 2 until one year of age Severe RVGE requiring hospitalization: During the period starting from 2 weeks after Dose 2 until two years of age | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •In all subjects, to determine if two doses of GSK Biologicals’ HRV vaccine given concomitantly with routine vaccinations* can prevent severe rotavirus gastroenteritis (RV GE) caused by the circulating wild-type RV strains during the period starting from 2 weeks after Dose 2 until 2 years of age. (*Whenever Oral Polio Vaccination (OPV) is used a minimum 2-week interval should be observed between HRV vaccine and OPV doses.) •In all subjects, to assess the safety of HRV vaccine with respect to definite intussusception (IS) within 31 days (Day 0-Day 30) after each HRV vaccine dose. ;Secondary Objective: HRV vac. efficacy and if 2 doses can prevent severe RV GE caused by the wild type G1, non-G1, & each non-G1 types, and severe GE, from 2 weeks after dose 2 up to 2 years and 3 years of age If 2 doses of HRV vac. can prevent RV GE caused by the circulating wild-type RV strains & requiring hospitalization & re-hydration therapy in a medical facility, up to 2 & 3 years of age If 2 doses of HRV vac. can prevent 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 safety of HRV vac. in terms of occurrence of serious adverse events (SAEs) from Dose 1 until Visit 5 & in terms of occ. of related SAEs until study end Safety of HRV vac. in terms of occ. of definite IS during the period starting from Dose 1 until 2 years Mortality up to the age of 2 years In a subset of 100 subjects per country, to assess the immunogenicity of HRV vac. in terms of RV IgA antibody titres 1 or 2 months after 2nd study vac. dose ;Primary end point(s): 1.Occurrence of severe RV GE* caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until two years of age. * Severe GE is defined as a gas-troenteritis episode requiring hospitalization and/or re-hydration therapy (equivalent to WHO plan B or C) in a medical facility with a score of 11 or greater on the Vesikari scale. 2.Occurrence o | — |
Countries
Hong Kong, Singapore, Taiwan
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed