The purpose of this study is to assess the reactogenicity and safety of GSK Biologicals' liquid human rotavirus vaccine in healthy infants aged 6 to 16 weeks at the time of the first dose of vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
50
Oral, two doses.
Oral, two doses.
GSK Investigational Site
Liucheng County, Guangxi, China
Occurrence of grade 3 solicited adverse events.
Time frame: Within the 8-day (Day 0 - 7) follow-up period after each vaccine dose.
Occurrence of each solicited adverse event.
Time frame: Within the 8-day (Day 0 - 7) follow-up period after each vaccine dose.
Occurrence of unsolicited adverse events.
Time frame: Within the 31-day (Day 0 - 30) follow-up period after any vaccine dose.
Occurrence of serious adverse events.
Time frame: Throughout the study period (Day 0 to Month 2).
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