Study to evaluate immunogenicity, reactogenicity and safety of Rotarix™ vaccine in Korean infants.

• Conditions: Rotavirus gateroenteritis; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-001545-81-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-10
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 684

Inclusion Criteria

-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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 684
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified