Evaluate Protective Efficacy of Diff Strengths of Human Rotavirus Vaccine After Admn of 2 Doses to Infants Aged 2 Months

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Infections, Rotavirus

Treatments

Biological: HRV vaccine

Study type

Interventional

Funder types

Industry

Identifiers

444563/006

Details and patient eligibility

About

The purpose of this study is to test how infants respond to different strengths of the human rotavirus vaccine.

Enrollment

2,640 patients

Sex

All

Ages

6 to 12 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks or a birth weight of >2000g.
Written informed consent obtained from the parent or guardian of the subject.

Exclusion criteria

Planned administration of oral polio vaccine during the period starting from 2 weeks before each dose of study vaccine(s) and ending 2 weeks after.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
History of diphtheria, tetanus, pertussis, Hib disease and/ or hepatitis B.
Previous vaccination against diphtheria, tetanus, pertussis, and/or Haemophilus influenzae type b.
History of allergic disease
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.
Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination)
Previous confirmed occurrence of RV GE.
Household contact with an immunosuppressed individual or pregnant women.
Administration of immunoglobulins and/or blood products since birth or planned administration during the study period