Study to Evaluate the Reactogenicity and Safety of Rotarix™ in Chinese Adults

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety of Rotarix ™ when administered in healthy adults aged 18 to 45 years in China.

Official Title
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Reactogenicity and Safety of a Single Dose of GlaxoSmithKline (GSK) Biologicals' Human Rotavirus (HRV) Vaccine (444563) in Healthy Adults

Conditions
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Infections, Rotavirus

Intervention / Treatment
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* Biological: Rotarix ™
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rotarix Group<br>Subjects will receive Rotarix™. | Biological: Rotarix ™<br>* Oral, single dose<br>|
| Placebo Comparator: Placebo Group<br>Subjects will receive placebo. | Biological: Placebo<br>* Oral, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of each solicited symptom |  | Within the 8-day (Day 0 - Day 7) follow-up period after the vaccine dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Rotavirus vaccine