EUCTR2015-001546-28-Outside-EU/EEA
Active, not recruiting
Not Applicable
Open, multi-centric, post-marketing surveillance (PMS) to evaluate the reactogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, Rotarix™ when administered according to a 0, 2 month schedule to Sri Lankan infants aged at least 6 weeks at the time of first vaccination. - Rota-069 PMS
Smithkline Beecham Pvt Limited0 sites522 target enrollmentJune 11, 2015
DrugsRotarix
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rotavirus Gastroenteritis
- Sponsor
- Smithkline Beecham Pvt Limited
- Enrollment
- 522
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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