Clinical trial NCT01086436: Study to Evaluate the Safety of Rotarix™ in Chinese Children
Official title: Reactogenicity and Safety of a Single Dose of GlaxoSmithKline (GSK) Biologicals' Human Rotavirus (HRV) Vaccine (444563) in Healthy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infections, Rotavirus
Keywords: Human Rotavirus vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-03-15
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the safety of Rotarix ™ when administered in healthy children aged 2 to 6 years in China.


Eligibility criteria: Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Occurrence of each solicited symptom
timeFrame: Within the 8-day (Day 0 - Day 7) follow-up period after the vaccine dose.
Secondary outcomes:
measure: Occurrence of unsolicited adverse events
timeFrame: Within the 31 days (Day 0 - Day 30) after the vaccine dose.
measure: Occurrence of serious adverse events
timeFrame: Throughout the study period following the vaccine dose.
Other outcomes:
Locations:
city: Liucheng County
country: China
facility: GSK Investigational Site
state: Guangxi
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Li RC, Li YP, Mo ZJ, Luo D, Huang T, Kong JL, Wang LH, Song NS, Liu A, Zhang H, Liao X, Karkada N, Han HH. 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. 2013 Aug;9(8):1638-42. doi: 10.4161/hv.25076. Epub 2013 Jun 4.