Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine in Healthy Infants

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Infections, Rotavirus

Treatments

Biological: Rotarix

Study type

Interventional

Funder types

Industry

Identifiers

NCT00425737

444563/004

Details and patient eligibility

About

To assess the efficacy, immune response and safety of the oral live attenuated HRV vaccine (Rotarix) in healthy infants approximately 2 months of age and previously uninfected with human rotavirus

Enrollment

405 patients

Sex

All

Ages

6 to 12 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy infants 6 and 12 weeks of age at the time of the first vaccination.
Written informed consent obtained from the parents or guardians of the subject.
Born after a normal gestation period (between 36 and 42 weeks).

Exclusion criteria

Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine or placebo or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs since birth. (Topical steroids are allowed.)
Use of antibiotics during the period starting from 7 days before each dose of vaccine(s) and ending 7 days after.
Any clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
Household contact with an immunosuppressed individual or pregnant woman.
Abnormal stool pattern.
Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
Previous confirmed occurrence of rotavirus gastroenteritis.