Last updated: 11/03/2018 15:17:18
Study to evaluate the safety of Rotarix™ in Chinese children
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Reactogenicity and safety of a single dose of GlaxoSmithKline (GSK) Biologicals’ human rotavirus (HRV) vaccine (444563) in healthy children
Trial description: The purpose of this study is to assess the safety of Rotarix ™ when administered in healthy children aged 2 to 6 years in China.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Occurrence of each solicited symptom
Timeframe: Within the 8-day (Day 0 - Day 7) follow-up period after the vaccine dose.
Secondary outcomes:
Occurrence of unsolicited adverse events
Timeframe: Within the 31 days (Day 0 - Day 30) after the vaccine dose.
Occurrence of serious adverse events
Timeframe: Throughout the study period following the vaccine dose.
Interventions:
Enrollment:
50
Primary completion date:
2010-16-04
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Li RC et al. (2013) Reactogenicity and safety of a liquid human rotavirus vaccine (RIX4414) in healthy adults, children and infants in China: Randomized, double-blind, placebo-controlled Phase I studies. Hum Vaccin Immunother. 9(8). [Epub ahead of print]
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
March 2010 to April 2010
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
2 - 6 years
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that their parents/guardians (Legally acceptable representative) can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female subject of Chinese origin, between, and including, 2 and 6 years of age at the time of vaccination.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs six months prior to the vaccine dose.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female subject of Chinese origin, between, and including, 2 and 6 years of age at the time of vaccination.
- Written informed consent obtained from the parent or legally acceptable representative of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Subjects who the investigator believes that their parents/guardians (Legally acceptable representative) can and will comply with the requirements of the protocol should be enrolled in the study.
Exclusion criteria:
- Chronic administration of immunosuppressants or other immune-modifying drugs six months prior to the vaccine dose.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 14 days of the Human Rotavirus vaccine or placebo with the exception of the routine childhood vaccines. Routine childhood vaccines must not be administered on the same day as the Human Rotavirus vaccine or placebo.
- Administration of immunoglobulins and/or any blood products since birth within three months preceding the study vaccine or planned administration during the study period.
- Major congenital defects or serious chronic illness.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of Intusussception or any chronic gastrointestinal disease that would predispose for Intusussception including any uncorrected congenital malformation of the gastrointestinal tract.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at the time of enrolment.
- Gastroenteritis within 7 days preceding the study vaccine or placebo administration.
- 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..
- Child in care.
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the study vaccine, or planned use during the study period.
Trial location(s)
Location
GSK Investigational Site
Liucheng County, Guangxi, China, 545200
Status
Study Complete
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
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2010-16-04
Actual study completion date
2010-16-04
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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Additional information
Results for study 113552 can be found on the GSK Clinical Study Register
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