A phase III, randomised study to evaluate the clinical consistency in terms of immunogenicity and reactogenicity of three production lots of the liquid formulation of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine and to evaluate the liquid formulation as compared to the lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose primary vaccination in healthy infants previously uninfected with HRV. - rota-061
- Conditions
- Two-dose immunisation at 3 and 4 months of age in healthy infants previously uninfected with HRV.
- Registration Number
- EUCTR2006-003239-61-FI
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1200
•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
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method