Infections, Rotavirus
Conditions
Keywords
Human Rotavirus vaccine
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.
Interventions
BIOLOGICALRotarix ™
Oral, single dose
BIOLOGICALPlacebo
Oral, single dose
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of each solicited symptom | Within the 8-day (Day 0 - Day 7) follow-up period after the vaccine dose |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of unsolicited adverse events | Within 31 days (Day 0 - Day 30) after the vaccine dose |
| Occurrence of serious adverse events | Throughout the study period following the vaccine dose |
Countries
China
Outcome results
None listed