Rotavirus Gastroenteritis
Conditions
Sponsors
Smithkline Beecham Pvt Limited
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 . A male or female at least 6 weeks of age at the time of the first vaccination. Written informed consent obtained from the parent or guardian of the subject. Are the trial subjects under 18? yes Number of subjects for this age range: 522 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: History of allergic disease or reactions likely to be exac-erbated by any component of the vaccine. Acute disease at the time of enrolment. Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception. Any contraindication as stated in the updated and approved Prescribing Information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the reactogenicity of Rotarix in terms of occur-rence of at least one grade “2” or grade “3” fever, vomiting or diarrhoea within a 8-day follow-up period after each vaccine dose;Secondary Objective: To assess the reactogenicity of Rotarix in terms of occurrence of solicited adverse events (AEs) within a 8-day follow-up period after each vaccine dose. To assess the safety of Rotarix in terms of occurrence of unsolicited AEs within a 31-day follow-up period after each vaccine dose. To assess the safety of Rotarix in terms of serious adverse events (SAEs) throughout the study period after Dose 1 of Rotarix ;Primary end point(s): Occurrence of at least one grade “2” or grade “3” fever, vomiting or diarrhoea;Timepoint(s) of evaluation of this end point: During the 8-day follow-up period after each vaccine dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): For each type of solicited symptoms, occurrence of the symptom Occurrence of unsolicited adverse event (AE) Occurrence of Serious adverse events;Timepoint(s) of evaluation of this end point: Solicited symptoms: During the 8-day follow-up period after each vaccine dose, Unsolicited AEs: During the 31-day follow-up period after each vaccine dose, SAEs:Throughout the study period (Month 3-4) | — |
Countries
Sri Lanka
Contacts
Public ContactClinical disclosure advisor
Smithkline Beecham Pvt Limited
Outcome results
None listed