Immunogenicity and safety study of two different formulations of GlaxoSmithKline (GSK) Biologicalsâ?? oral live attenuated human rotavirus (HRV) vaccine, Rotarix in healthy infants.
- Registration Number
- CTRI/2014/06/004654
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 450
• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
• A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination.
• Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Birth weight >2000 g.
•Child in care
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the period starting 30 days before the first dose of study vaccines) (Day-29 to Day 1), or planned use during the study period.
•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
•Administration of any chronic drug therapy to be continued during the study period.
•Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose of vaccine administration and ending at Visit 3; with the exception of the inactivated influenza vaccine, which is allowed at any time during the study, and other licensed routine childhood vaccinations, according to the local immunization practice.
•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).
•History of confirmed RV GE.
•Previous vaccination against RV.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, (including Severe Combined Immunodeficiency [SCID] disorder) based on medical history and physical examination (no laboratory testing required).
•Uncorrected congenital malformation (such as Meckelâ??s diverticulum) of the gastrointestinal tract that would predispose for Intussusception (IS).
•History of IS.
•Very prematurely born infants (born <=28 weeks of gestation).
•Hypersensitivity to latex.
•Family history of congenital or hereditary immunodeficiency.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
•Major congenital defects or serious chronic illness.
•History of any neurological disorders or seizures.
•Acute disease and/or fever at the time of enrolment. This warrants deferral of vaccination.
ï?Fever is defined as temperature ï?³38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity, the axilla or the rectum.
ï?Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever, may be enrolled at the discretion of the investigator.
•Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or medical history.
•Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
•Administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab).
•GE within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anti-RV IgA antibody concentrationsTimepoint: Serum anti-RV IgA antibody concentrations, expressed as GMCs, one month post dose 2 of HRV vaccine
- Secondary Outcome Measures
Name Time Method Anti-RV IgA antibody concentrations.Timepoint: Anti-RV IgA antibody seroconversion rate, one month post dose 2 of HRV vaccine. <br/ ><br> <br/ ><br>;Serious adverse eventsTimepoint: Occurrence of SAEs from dose 1 of HRV lyophilized vaccine and HRV liquid vaccine up to study end.;Solicited general symptomsTimepoint: Occurrence of each type of solicited general symptom within the 8-day (Day1-Day 8) solicited follow-up period, after each dose of HRV lyophilized vaccine and HRV liquid.;Unsolicited adverse eventsTimepoint: Occurrence of unsolicited AEs within 31 days <br/ ><br>(Day 1 Day 31) after any dose of HRV lyophilized vaccine and HRV liquid vaccine according to Medical Dictionary for Regulatory Activities (MedDRA) classification.