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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Infections, Rotavirus

Treatments

Biological: Placebo

Biological: Rotarix ™

Study type

Interventional

Funder types

Industry

Identifiers

NCT01162590

113545

Details and patient eligibility

About

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

Enrollment

52 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.