Status:
COMPLETED
Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
6-167 years
Brief Summary
This post marketing surveillance will evaluate reactogenicity and safety data of human rotavirus vaccine when administered to healthy infants according to the Prescribing Information in India.
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in this PMS.
- A male or female infant, from the age of 6 weeks at the time of the first vaccination and less than 24 weeks of age at the time of second 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.
- Concurrently participating in another clinical study, at any time during the surveillance period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Acute disease at the time of enrolment.
- Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose the subject for intussusception.
- Known hypersensitivity after previous administration of rotavirus vaccine or to any component of the vaccine.
- Gastroenteritis within 7 days preceding vaccination.
Key Trial Info
Start Date :
August 3 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 23 2010
Estimated Enrollment :
332 Patients enrolled
Trial Details
Trial ID
NCT00938327
Start Date
August 3 2009
End Date
April 23 2010
Last Update
January 2 2018
Active Locations (12)
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1
GSK Investigational Site
Bangalore, India, 560 011
2
GSK Investigational Site
Bangalore, India, 560 095
3
GSK Investigational Site
Chennai, India, 600 033
4
GSK Investigational Site
Delhi, India, 110085