Status:
COMPLETED
A Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
6-14 years
Phase:
PHASE3
Brief Summary
The aim of this study is to explore horizontal transmission of the HRV (Human Rotavirus) vaccine strain within a family from the twin vaccinated with Rotarix to the twin receiving placebo. The Protoco...
Detailed Description
This is a Phase 3b study. Three doses of Infanrix® hexa will be administered to all subjects at the discretion of the investigator. One complimentary dose of Rotarix will be administered to all infan...
Eligibility Criteria
Inclusion
- Subjects with a live twin living in the same household who is also enrolled in this study.
- Born after a gestation period of ≥32 weeks,
- Discharged from hospital neonatal care stay,
- 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 14 weeks of age at the time of the first study vaccination.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the parent or guardian of the subjects.
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.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Any clinically significant history of chronic gastrointestinal disease.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Contact with an immunosuppressed individual.
- 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).
- Chronic administration of immunosuppressants since birth.
- Gastroenteritis within 7 days preceding the first study vaccine administration.
- Documented HIV-positive subject.
Key Trial Info
Start Date :
January 23 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2008
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00396630
Start Date
January 23 2007
End Date
February 13 2008
Last Update
February 6 2018
Active Locations (1)
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1
GSK Investigational Site
Santo Domingo, Dominican Republic