The purpose of this study is to evaluate the lot-to-lot consistency of three production lots of GSK Biologicals' HRV vaccine in terms of immunogenicity and safety in healthy infants aged 2 months at the time of first vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
854
GSK Investigational Site
Cali Colombia, Colombia
GSK Investigational Site
Mexico City, Mexico
GSK Investigational Site
Lima, Peru
GSK Investigational Site
Serum anti-rotavirus Immunoglobulin A (IgA) antibody concentration expressed as Geometric Mean Concentrations (GMCs).
Time frame: Two months after Dose 2.
Serum anti-rotavirus IgA antibody concentration expressed as GMCs in a subset of subjects.
Time frame: Two months after Dose 1.
Seroconversion rates to anti-rotavirus IgA antibody
Time frame: Two months after Dose 1 (in a subset of subjects) and Dose 2 (all subjects).
Vaccine take rates in a subset of subjects.
Time frame: Two months after each dose
Presence of rotavirus in stool samples in a subset of subjects
Time frame: On the day of each vaccination and on planned days following each vaccination.
For each type of solicited symptom, occurrence of the symptom
Time frame: During the 8-day follow-up period after each vaccine dose
Occurrence of unsolicited symptoms
Time frame: During the 31-day follow-up period after each vaccine dose.
Occurrence of serious adverse events
Time frame: Throughout the study period.
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