Infections, Rotavirus
Conditions
Brief summary
The purpose of this study is to test how infants respond to different strengths of the human rotavirus vaccine.
Interventions
BIOLOGICALHRV vaccine
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of RV GE | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum RV IgA antibody titre, Viral shedding, Seroprotection/seropositivity status for DTPwHBVHib antigens, Solicited, unsolicited & SAE | — |
Outcome results
None listed