Status:
COMPLETED
A Study to Test 2 Doses of the HRV Vaccine in Healthy Infants.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
6-13 years
Phase:
PHASE3
Brief Summary
The main objectives of this study are: 1) In a subset (N = 20 000), to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose ...
Detailed Description
The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-13 weeks of age at the time of Dose 1, according to a 0, 1 to 2-month schedule. Routine ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy infants 6-13 weeks of age at the time of the first study vaccination whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits)
- Exclusion criteria:
- 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. (Topical steroids are allowed.)
- 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
- 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
Exclusion
Key Trial Info
Start Date :
August 5 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2005
Estimated Enrollment :
63227 Patients enrolled
Trial Details
Trial ID
NCT00140673
Start Date
August 5 2003
End Date
October 20 2005
Last Update
December 30 2019
Active Locations (17)
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1
GSK Investigational Site
Villanueva, Mendoza Province, Argentina, 5521
2
GSK Investigational Site
Belém, Pará, Brazil, 66 090 000
3
GSK Investigational Site
Valparaíso, Región de Valparaíso, Chile
4
GSK Investigational Site
Concepción, Región Del Biobio, Chile