Status:
COMPLETED
To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
This trial will be conducted to evaluate the immunogenicity, reactogenicity and safety of the liquid formulation of GSK Biologicals' HRV vaccine compared to the lyophilized formulation of GSK Biologic...
Eligibility Criteria
Inclusion
- Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks.
- Written informed consent obtained from the parent or guardian of the subject.
Exclusion
- se of any investigational or non-registered product (drug or vaccine) other than the HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccines not foreseen by the study protocol except for DTPw, HBV/Hib and OPV vaccines within 14 days before each dose of HRV vaccine and ending 14 days after.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Household contact with an immunosuppressed individual or pregnant women.
- Previous confirmed occurrence of RV GE.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2007
Estimated Enrollment :
1274 Patients enrolled
Trial Details
Trial ID
NCT00363545
Start Date
September 1 2006
End Date
April 12 2007
Last Update
June 8 2018
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
David, Panama
2
GSK Investigational Site
La Chorrera, Panama
3
GSK Investigational Site
Panama City, Panama