Study to evaluate immunogenicity, reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy Taiwanese infants who received hepatitis B immunoglobulin after birth.

Active, not recruiting

• Conditions: Healthy volunteers (Two-dose primary vaccination at 2 and 4 months of age in healthy infants previously unin-fected with HRV infection); Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-003731-63-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-13
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Active
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

•Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).
•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)/LAR(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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 15
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

•Child in care.
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs with the exception of HBIG since birth. For corticosteroids, prednisone >20 mg/day, or equivalent, inhaled and topical steroids are allowed.
•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 (pharmaceutical product or device).
•Previous vaccination against RV.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•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.
-Fever is defined as temperature = 37.5°C (99.5°F) on oral, axillary or tympanic setting, or = 38.0°C (100.4°F) on rectal setting. The preferred route for recording temperature in this study will be tympanic on rectal setting.
-Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
•Administration of immunoglobulins (with the exception of HBIG) and/or any blood products since birth or planned administration during the study period.
•GE within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
•Previous confirmed occurrence of RV GE.

Study & Design

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