Two-dose immunization according to 0, 1 or 2-month schedule against rotavirus disease in healthy infants aged 6 to 14 weeks at the time of the first dose. Rotavirus infection.
Conditions
Interventions
Product Name: Live attenuated human rotavirus (HRV) vaccine, oral
Product Code: RIX4414
Pharmaceutical Form: Powder and solvent for oral suspension
INN or Proposed INN: HRV
Current Sponsor code: RIX44
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 (e.g., completion of the diary cards, return for follow-up visits, collection of stool samples) should be enrolled in the study. - A male or female between, and including, 6 and 14 weeks (42 – 104 days) of age at the time of the first vaccination. - Written informed consent obtained from the parent or guardian of the subject. - Free of obvious health problems as established by medical history and clinical examination before entering into the study. - Birth weight > 2000g. 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 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. - 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 allowed.) - History of diphtheria, tetanus, pertussis, Hib disease and/ or hepatitis B disease (in all subjects). Only for subjects in Spain: history of meningococcal group C disease. Only for subjects in France and Germany: history of disease caused by Streptococcus pneumoniae. - History of use of experimental rotavirus vaccine. - Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b (in all subjects). Only for subjects in Spain: previous vaccination against meningococcal group C. Only for subjects in France and Germany: previous vaccination against Streptococcus pneumoniae. - Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract, IS 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 is required). - History of allergic disease or reaction likely to be exacerbated 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).) - Gastroenteritis within 7 days preceding the first study vaccine administration (warrants deferral of the vaccination). - A family history of congenital or hereditary immunodeficiency. - Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. - History of any neurologic disorders or seizures. - Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of two doses of GSK Biologicals’ HRV vaccine given concomitantly with specific childhood vaccinations against any RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period.;Secondary Objective: Efficacy of 2 doses HRV vaccine given concomitantly with specific childhood vaccinations: -against severe RVGE, against hospitalization due to RVGE, against any medical attention for RVGE, caused by circulating wild-type RV strains during first/second/combined follow-up (FU) period. -against any/severe RVGE caused by circulating wild-type RV strains of G1/non-G1 serotype during first and second/combined (severe RV GE only) FU period. -against any and severe RVGE caused by circulating wild-type RV strains during period Dose 1-Visit 5. Efficacy against any/severe RVGE during first efficacy FU period in subjects with complete vaccination course before RV epidemic season/subjects vaccinated during RV epidemic season. Immunogenicity of HRV vaccine after 2nd dose. Effect of HRV vaccine on immune response to coadministered childhood vaccines. Reactogenicity/safety of 2 doses HRV vaccine given concomitantly with specific childhood vaccinations compared with placebo. ;Primary end point(s): - Occurrence of any RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period. | — |
Countries
Czech Republic, Finland, Italy, Spain
Outcome results
None listed