Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5 years of age. GSK Biologicals has developed a vaccine against human rotavirus gastroenteritis. In this study, the immunogenicity, reactogenicity and safety of the HRV vaccine will be evaluated when stored or reconstituted in circumstances different from the recommendations: i.e. when not reconstituted with a buffer or when stored for 7 days at 37°C before reconstitution. In addition, the effect of feeding will be explored for HRV vaccine reconstituted without buffer.
Assess the effect on immunogenicity of administration of vaccine without buffering agent \& assess heat stability in terms of immunogenicity, reactogenicity \& safety of GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine following a 0,2 m schedule, in healthy infants previously uninfected with human rotavirus
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
450
GSK Investigational Site
Bangkok, Thailand
GSK Investigational Site
Bangkok, Thailand
Percentage of subjects with vaccine take
Time frame: At 2 months post-Dose 2
Percentage of subjects who seroconverted (percentage of subjects with concentrations ≥ 20 U/mL in subjects who were negative for rotavirus (RV) before vaccination)
Time frame: At 2 months post-Dose 2
Evaluation of the serum anti-RV IgA (immunoglobulin A) antibody concentrations expressed as Geometric Mean Concentrations (GMC)
Time frame: At 2 months post-Dose 2
Rotavirus antigen shedding in planned stool samples
Time frame: At Day 0, Day 7 and Day 15 post each study vaccine dose
Presence of RV in gastroenteritis (GE) episode stools collected
Time frame: From Dose 1 of HRV vaccine/placebo up to 2 months post-Dose 2
For each type of solicited symptoms, occurrence of the symptom
Time frame: Within the 15-day (Day 0-14) solicited follow-up period after each study vaccine dose
Occurrence of any Grade 2 or Grade 3 fever, vomiting or diarrhea
Time frame: Within the 15-day (Day 0-14) solicited follow-up period after each study vaccine dose
Occurrence of unsolicited adverse events (AEs) according to Medical Dictionary for Regulatory Activities (MedDRA) classification
Time frame: Within 31 days (Day 0-30) after each study vaccine dose
Occurrence of serious adverse events (SAEs) according to MedDRA classification
Time frame: Throughout the study period (Day 0 to Month 4)
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