Last updated: 11/07/2018 07:37:47
Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Immunogenicity, reactogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy Taiwanese infants who received hepatitis B immunoglobulin after birth.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of seroconverted subjects for serum anti-rotavirus immunoglobulin A (IgA) antibody.
Timeframe: 2 months post-Dose 2 (at study Month 4)
Secondary outcomes:
Serum anti-rotavirus IgA antibody concentrations.
Timeframe: 2 months post-Dose 2 (at study Month 4)
Number of subjects reporting solicited general symptoms.
Timeframe: During the 8-day (Days 0-7) post-vaccination period
Number of subjects with rotavirus (RV) present in the gastroenteritis (GE) stool sample.
Timeframe: From Day 0 (first vaccine dose) to study Month 4 (2 months post-Dose 2)
Number of subjects reporting unsolicited adverse events (AEs).
Timeframe: Within the 31-day (Days 0-30) follow-up period after vaccination
Number of subjects reporting serious adverse events (SAEs).
Timeframe: During the entire study period (from Dose 1 at Day 0 up to Month 4)
Interventions:
Enrollment:
15
Primary completion date:
2011-18-04
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Lu CY et al. (2013) Immunogenicity, reactogenicity, and safety of a human rotavirus vaccine, Rotarix, in Taiwanese infants who received a dose of hepatitis B immunoglobulin after birth. J Formos Med Assoc. 112(9):574-577.
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
November 2010 to April 2011
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
6 - 12 weeks
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
Exclusion criteria:
- 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.
Child in care.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2011-18-04
Actual study completion date
2011-18-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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