Status:
COMPLETED
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
6-19 years
Brief Summary
This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (se...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- History of allergic disease or reactions likely to be exacerbated 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
Key Trial Info
Start Date :
November 22 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 26 2009
Estimated Enrollment :
522 Patients enrolled
Trial Details
Trial ID
NCT00779779
Start Date
November 22 2008
End Date
August 26 2009
Last Update
August 28 2018
Active Locations (1)
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1
GSK Investigational Site
Colombo, Sri Lanka, 03