EUCTR2011-003731-63-Outside-EU/EEA
Active, not recruiting
Not Applicable
A phase IV, open, multi-centre study to assess the immunogenicity, reactogenicity and safety of two doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy Taiwanese infants who received hepatitis B immunoglobulin at birth. - Rota-077 PMS
DrugsRotarix
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GlaxoSmithKline Biologicals
- Enrollment
- 15
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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