Immunization of healthy infants against HRV disease/illness.
Conditions
Interventions
Product Name: Live attenuated human rotavirus (HRV) vaccine, oral
Product Code: RIX4414
Pharmaceutical Form: Oral liquid
INN or Proposed INN: HRV vaccine (live)
Current Sponsor code: RIX4414
Other de
Sponsors
GlaxoSmithKline
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 should be enrolled in the study. ? A male or female between, and including, 6 and 12 weeks (42 – 90 days) of age at the time of the first vaccination. ? Written informed consent obtained from the parent or guardian of the subject. ? Healthy subjects as established by medical history and clinical examination before entering into the study. ? Born after a gestation period of 36 to 42 weeks inclusive. Are the trial subjects under 18? yes Number of subjects for this age range: 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 investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Planned administration of a vaccine not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) and ending 14 days after. Concurrently participating in another clinical study Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition (determined by the investigator). History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required). Major congenital defects/serious chronic illness. Acute disease at time of enrolment. GE within 7 days preceding the study vaccine administration Contact with an immunosuppressed individual or pregnant women. administration of immunoglobulins and/or blood products since birth or planned . Previous confirmed occurrence of RV GE. History of neurological disorders or seizures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess immunogenicity of the liquid formulation of GSK Biologicals' HRV vaccine compared to the lyophilized formulation of GSK Biologicals’ HRV vaccine in terms of vaccine take on combined doses.;Secondary Objective: ? To assess immunogenicity of the two formulations of GSK Biologicals' HRV vaccine in terms of seroconversion rates after each dose and on combined doses. ? To assess immunogenicity of the two formulations of GSK Biologicals' HRV vaccine in terms of Geometric Mean Concentration (GMC) after each dose. ? To assess the reactogenicity and safety of the study vaccines.;Primary end point(s): ? Proportion of subjects with vaccine take on combined doses. | — |
Countries
Finland
Outcome results
None listed