Two-dose immunisation at 3 and 4 months of age in healthy infants previously uninfected with HRV.
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 des
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 between, and including, 10-17 weeks (70 - 125 days) 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. •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) within 30 days preceding the first dose of any of the study vaccines, or planned use during the study period. •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior 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 by the study protocol within 30 days of the first dose of vaccine. •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). •Previous vaccination against RV. •Previous vaccination against diphtheria, tetanus, pertussis, polio or Hib. •Previous confirmed occurrence of RV GE. •History of diphtheria, tetanus, pertussis, hepatitis B, polio and/ or Hib disease. •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). •A family history of congenital or hereditary immunodeficiency. •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). •Major congenital defects or serious chronic illness. •Uncorrected congenital malformation (such as Meckel’s diverticulum) of the gastrointestinal tract that would predispose for IS. •History of any neurologic disorders or seizures. •Acute disease at time of enrolment. (Acute disease is defined as the presence of moderate or severe illness with or without fever i.e. temperature >= 37.5°C as measured by an axillary thermometer or >= 38.0°C as measured by a rectal thermometer). Temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject. •GE within 7 days preceding the study vaccine administration (warrants deferral of the vaccination). •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To demonstrate the lot-to-lot consistency of the liquid formulation of GSK Biologicals’ HRV vaccine in terms of immunogenicity as measured by serum anti-rotavirus IgA antibody levels one month after Dose 2. Consistency will be reached if, for all pairs of lots, the two-sided 95% CIs for the ratio of anti-rotavirus IgA antibody GMCs one month after Dose 2 are within the [0.5; 2] clinical limit interval. •To demonstrate non-inferiority of the liquid formulation of GSK Biologicals' HRV vaccine to that of lyophilised formulation of GSK Biologicals’ HRV vaccine in terms of seroconversion rates one month after Dose 2. Non-inferiority will be reached if the upper limit of the two-sided asymptotic standardised 95% CI for the difference in seroconversion rate between the lyophilised formulation of HRV vaccine and (minus) the liquid formulation of HRV vaccine is less than or equal to 10%. ;Secondary Objective: •To demonstrate non-inferiority of the liquid formulation of GSK Biologicals' HRV vaccine to that of lyophilised formulation of GSK Biologicals’ HRV vaccine in terms of serum anti-rotavirus IgA antibody levels one month after Dose 2. Non-inferiority will be reached if the upper limit of the two-sided 95% CI for the ratio of anti-rotavirus IgA antibody GMCs one month after Dose 2 between the lyophilised formulation of HRV vaccine and (over) the liquid formulation of HRV vaccine is less than or equal to 2. •To assess the lot-to-lot consistency of the liquid formulation of GSK Biologicals’ HRV vaccine in terms of reactogenicity. •To assess the safety of the study vaccines. ;Primary end point(s): •Serum anti-rotavirus IgA antibody concentration at Visit 3. •Seroconversion to anti-rotavirus IgA antibody at Visit 3. Seroconversion is defined as appearance of anti-rotavirus IgA antibody concentration >= 20 units (U)/millilitre (ml) in subjects initially (i.e. prior to the first dose of HRV vaccine) seronegative (i.e. with anti-rotavirus IgA antibody concentra | — |
Countries
Finland
Outcome results
None listed