Status:
COMPLETED
Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the lot-to-lot consistency of three production lots of GSK Biologicals' HRV vaccine in terms of immunogenicity and safety in healthy infants aged 2 months at t...
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 at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- 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 planned use during the study period.
- Child is unlikely to remain in the study area for the duration of the study.
- Previous confirmed occurrence of rotavirus gastroenteritis.
- Gastroenteritis within 7 days preceding the study vaccine administration.
- Household contact with an immunosuppressed individual or pregnant woman.
- Use of antibiotics during the period starting from 7 days before dose 1 of vaccine(s).
- Planned administration of a vaccine (other than routine pediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) and ending 14 days after.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- 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.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- Acute disease at time of enrollment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2004
Estimated Enrollment :
854 Patients enrolled
Trial Details
Trial ID
NCT00757770
Start Date
August 1 2003
End Date
January 1 2004
Last Update
September 7 2016
Active Locations (4)
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1
GSK Investigational Site
Cali Colombia, Colombia
2
GSK Investigational Site
Mexico City, Mexico, 14050
3
GSK Investigational Site
Lima, Peru, Lima
4
GSK Investigational Site