Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Infections, Rotavirus

Treatments

Biological: Rotarix TM

Study type

Interventional

Funder types

Industry

Identifiers

NCT01198769

114351

Details and patient eligibility

About

The purpose of this study is to assess immunogenicity and safety of Rotarix TM when administered in healthy Taiwanese infants (aged 6 to 12 weeks at the time of first vaccination) who received Hepatitis B immunoglobulin after birth.

Enrollment

15 patients

Sex

All

Ages

6 to 12 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
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(s)/Legally Acceptable Representative(s) of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Infants who have received a previous dose of hepatitis B immunoglobulin after birth.

Exclusion criteria

Child in care.
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs with the exception of Hepatitis B immunoglobulin since birth. Child is unlikely to remain in the study area for the duration of the study.
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
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.
Previous vaccination against rotavirus.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Family history of congenital or hereditary immunodeficiency.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
Major congenital defects or serious chronic illness.
Acute disease and/or fever at the time of enrolment.
Administration of immunoglobulins (with the exception of HBIG) and/or any blood products since birth or planned administration during the study period.
Gastroenteritis within 7 days preceding the study vaccine administration.
Previous confirmed occurrence of Rotavirus gastroenteritis.