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
6-24 years
Brief Summary
This protocol posting deals with objectives and outcome measures of the primary phase at one month post-Dose 2. This Post Marketing Surveillance (PMS) will collect safety data on the use of human rota...
Detailed Description
The protocol posting has been amended to reflect the two new vaccine presentations that have been launched in Korea. The current PMS will thus collect safety information from subjects who have receive...
Eligibility Criteria
Inclusion
- Infants who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the PMS.
- A male or female infant from the age of 6 weeks at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the infant.
Exclusion
- • At the time of PMS entry, the contraindications and precautions of use indicated in the prescribing information should be checked and the infant must not be included in the PMS if there is any contraindication. Any changes in the locally approved Prescribing Information must be implemented immediately.
Key Trial Info
Start Date :
September 2 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 15 2013
Estimated Enrollment :
3111 Patients enrolled
Trial Details
Trial ID
NCT00750893
Start Date
September 2 2008
End Date
June 15 2013
Last Update
March 3 2020
Active Locations (1)
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1
GSK Investigational Site
Seoul, South Korea, 122-896