The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of GSK Biologicals' HRV liquid vaccine compared to GSK Biologicals' HRV lyophilized vaccine when administered as a two-dose primary vaccination in healthy infants aged 6-10 weeks at dose one, with no previous history of rotavirus illness or vaccination. While the lyophilized formulation of the HRV vaccine was licensed in India in February 2008, this study is conducted to generate additional clinical data for the liquid formulation of the HRV vaccine in India, as recommended by New Drug Advisory Committee on Vaccines (NDAC-Vaccines) of Drug Controller General of India (DCGI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
451
Two doses administered orally according to a 0, 1-month schedule.
Two doses administered orally according to a 0, 1-month schedule.
GSK Investigational Site
Bangalore, India
GSK Investigational Site
Kolkata, India
GSK Investigational Site
Ludhiana, India
GSK Investigational Site
Mumbai, India
GSK Investigational Site
Pune, India
GSK Investigational Site
Pune, India
GSK Investigational Site
Vellore, India
GSK Investigational Site
Vellore, India
Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations
Serum anti-RV IgA antibody concentrations were expressed as geometric mean concentrations (GMCs).
Time frame: At Month 2
Percentage of Seroconverted Subjects for Anti-RV IgA Antibodies
Seroconversion is defined as: - for subjects with a pre-vaccination anti-RV IgA antibody concentration lower than (\<) 20 U/mL, seroconversion is achieved when the post-vaccination concentration is greater than or equal to (≥) 20 U/mL and \- for subjects with a pre-vaccination anti-RV IgA antibody concentration ≥ 20 U/mL, seroconversion is achieved when the post-vaccination concentration is ≥ 2 times the pre-vaccination concentration.
Time frame: At Month 2
Number of Subjects With Any Solicited General Adverse Events (AEs)
Solicited general AEs assessed were fever (defined as temperature ≥ 38.0°C/100.4°F, the preferred location for measuring temperature in this study being the oral cavity, the axilla and the rectum), irritability/fussiness, diarrhea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents ≥1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.
Time frame: During the 8-day follow-up period after each vaccination (vaccines administered at Day 1 and Month 1)
Number of Subjects With Any Unsolicited AEs
An unsolicited AE is defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, and reported in addition to those solicited during the clinical study and any 'solicited' AE with onset outside the specified period of follow-up for solicited AE. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.
Time frame: During the 31-day follow-up period across doses (vaccines administered at Day 1 and Month 1)
Number of Subjects With Any Serious Adverse Events (SAEs)
SAEs assessed included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization and/or resulted in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination.
Time frame: Throughout the study period (from Day 1 up to Month 2)
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