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
Completed
Completed
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:
Biological/vaccine: Rotarix TM
Enrollment:
15
Observational study model:
Not applicable
Primary completion date:
2011-18-04
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
Completed
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
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website