Status:
COMPLETED
Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
2-3 years
Phase:
PHASE3
Brief Summary
This Year 3 extension of the main study rota-028, 029 or 030 is conducted to evaluate vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during third year of life in infants previousl...
Detailed Description
Note that no new subjects will be recruited in this extension phase studies. The expected total enrolment for the primary studies was as follows: rota-028: 5700 rota-029: 3018 rota-030: 1102
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 the study.
- A male or female between, and including, 6 and 12 weeks of age in Hong Kong and Taiwan or 11 to 17 weeks of age in Singapore at the time of the first vaccination according to the country recommendations for the routine vaccination schedules.
- Written informed consent obtained from the parent or guardian of the subject, prior any study procedure.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine or placebo, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- Child is unlikely to remain in the study area for the duration of the study
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
- Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. Oral intake of immunoglobulins is allowed.
- Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
- First or second degree of consanguinity of parents.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
8687 Patients enrolled
Trial Details
Trial ID
NCT00329745
Start Date
January 1 2007
End Date
July 1 2008
Last Update
December 9 2016
Active Locations (4)
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1
GSK Investigational Site
Singapore, Singapore, 119074
2
GSK Investigational Site
Singapore, Singapore, 228510
3
GSK Investigational Site
Singapore, Singapore, 229899
4
GSK Investigational Site
Singapore, Singapore, 308433