Clinical trial NCT01162590: Study to Evaluate the Reactogenicity and Safety of Rotarix™ in Chinese Adults
Official title: Reactogenicity and Safety of a Single Dose of GlaxoSmithKline (GSK) Biologicals' Human Rotavirus (HRV) Vaccine (444563) in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infections, Rotavirus
Keywords: Human Rotavirus vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-07-14
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
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 adults aged 18 to 45 years in China.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female subject of Chinese origin, 18 years to 45 years inclusive of age at the time of the vaccination.
* Written informed consent obtained from the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Female subjects of non-childbearing potential may be enrolled in the study.
* Female subjects of childbearing potential may be enrolled in the study, if the subject:

  * has practiced adequate contraception for 30 days prior to vaccination, and
  * has a negative pregnancy test on the day of vaccination, and
  * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of vaccination.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history, physical examination or laboratory tests.
* Any clinically significant history of chronic gastrointestinal disease including uncorrected congenital malformation of gastrointestinal tract that would predispose for Intusussception.
* Gastroenteritis within 7 days preceding the study vaccine or placebo administration.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination. Planned administration/ administration of a vaccine not foreseen by the study protocol within 14 days of the study vaccine or placebo and ending 14 days after.
* 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
* Administration of immunoglobulins and/ or any blood products within the three months preceding the dose of study vaccine or planned administration during the study period.
* Acute disease at the time of enrolment.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* History of chronic alcohol consumption and/ or drug abuse.

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 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.