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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Hepatitis B

Treatments

Biological: Rotarix

Study type

Interventional

Funder types

Industry

Identifiers

NCT00429481

444563/007

Details and patient eligibility

About

To assess the efficacy, immune response and safety of 2 doses of HRV vaccine (at different concentrations) in healthy infants aged approximately 3 months previously uninfected with human rotavirus.

Enrollment

2,464 patients

Sex

All

Ages

11 to 17 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy infants 11 and 17 weeks of age at the time of the first vaccination, born after a normal gestation period (between 36 and 42 weeks).
Written informed consent obtained from the parents or guardians of the subject.

Exclusion criteria

Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Previous vaccination against or history of or intercurrent diphtheria, tetanus, pertussis, polio and/or Hib.
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 including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.
History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
GE within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
Household contact with an immunosuppressed individual or pregnant woman.
Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
Previous confirmed occurrence of RV GE.