Status:
COMPLETED
Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Rotavirus Vaccines
Eligibility:
All Genders
6-12 years
Phase:
PHASE4
Brief Summary
The aim of this study is to assess the immunogenicity, reactogenicity and safety of the human rotavirus (HRV) Rotarix ™ vaccine when administered in healthy infants aged approximately 6-12 weeks at th...
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 to 12 weeks of age at the time of the first dose of the vaccination.
- Written informed consent obtained from the parents or guardians of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born after a normal gestation period of between 37 and 41 weeks + 6 days inclusive.
- Subjects for whom the vaccination history is available from vaccination diary cards or medical charts.
Exclusion
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine with the exception of the routine infant vaccines.
- 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.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- 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.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Gastroenteritis (GE) within 7 days preceding the study vaccine administration.
- Previous confirmed occurrence of RV GE.
- Previous vaccination with rotavirus vaccine or planned use during the study period.
Key Trial Info
Start Date :
August 25 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2010
Estimated Enrollment :
684 Patients enrolled
Trial Details
Trial ID
NCT00969228
Start Date
August 25 2009
End Date
July 23 2010
Last Update
January 18 2020
Active Locations (18)
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1
GSK Investigational Site
Busan, South Korea, 614-735
2
GSK Investigational Site
Daegu, South Korea, 700-712
3
GSK Investigational Site
Daegu, South Korea, 701-600
4
GSK Investigational Site
Daejeon, South Korea, 301-723