Primary immunisation of pre–term infants against human rotavirus gastroenteritis (GE)
Conditions
Interventions
Trade Name: Rotarix
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Human rota virus RIX4414 strain
Concentration type: not less then
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 infant between, and including, 6 and 12 weeks of age at the time of first study vaccination. •Written informed consent obtained from the parent/guardian of the subject. •Medically stable* pre–term infants, born within a gestational period of 27 –36 weeks. * Medically stable refers to the condition of pre–term infants who do not require significant medical support or ongoing management for a debilitating disease and who have demonstrated a clinical course of sustained recovery as established by medical history and physical examination before entering into the study. •Planned to be discharged from hospital’s neonatal stay on or before the day of the first HRV vaccine/Placebo administration 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 within 30 days preceding the first dose of study vaccine, or planned use during the study period. •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune–modifying drugs from birth to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, ? 0.5 mg/kg/day. Inhaled and topical steroids are allowed). •Planned administration/administration of a vaccine not foreseen (except routine paediatric vaccines) by the study protocol within the period starting from birth up to study end. •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). •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. •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. •Major congenital defects or serious chronic illness. •History of any neurologic disorders or seizures. Grade I and II intra–ventricular bleeding are allowed. •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. Axillary temperature <37.5°C (99.5°F) / Rectal temperature <38°C (100.4°F) •Administration of immunoglobulins, and/or any blood products within one month (30 days) preceding the first dose of study vaccines or planned administration during the study period. Monoclonal anti–RSV therapy/prophylaxis and recombinant erythropoietin are allowed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): •Occurrence of SAEs throughout the study period;Main Objective: •To assess the safety of GSK Biologicals’ HRV vaccine in terms of occurrence of serious adverse events (SAEs), throughout the study period in pre–term infants receiving HRV vaccine versus pre–term infants receiving placebo.; Secondary Objective: •To assess the safety of GSK Biologicals’ HRV vaccine in terms of unsolicited adverse events (AEs) within 31 days (Day 0–Day 30) after any dose of the HRV vaccine/Placebo, in pre–term infants receiving HRV vaccine versus pre–term infants receiving placebo. In a subset of subjects (N = 300) Reactogenicity •To assess the reactogenicity of GSK Biologicals’ HRV vaccine in terms of occurrence of solicited symptoms within 15 days (Day 0–Day 14) after each dose of the HRV vaccine/Placebo in pre–term infants receiving HRV vaccine versus pre–term infants receiving placebo. Immunogenicity •To assess the immunogenicity of GSK Biologicals’ HRV vaccine at Visit 3 (Month 2 or 3), when administered concomitantly with routine immunisation. | — |
Countries
France, Portugal, Spain
Outcome results
None listed