The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of the Porcine circovirus (PCV)-free liquid formulation of GlaxoSmithKline Biologicals' SA (GSK) oral live attenuated human rotavirus (HRV) study intervention compared to GSK's liquid oral live attenuated HRV study intervention in healthy Chinese infants 6 to 16 weeks of age at the time of the first study intervention administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,000
2 doses of GSK's liquid oral live attenuated HRV study intervention administered orally at Day 1 and Month 1, according to the immunization schedule for HRV study intervention licensed outside of China.
2 doses of PCV-free liquid formulation of GSK's oral live attenuated HRV study intervention administered orally at Day 1 and Month 1, according to the immunization schedule for HRV study intervention licensed outside of China.
GSK Investigational Site
Baoshan, China
GSK Investigational Site
Baoshan, China
GSK Investigational Site
Baoshan, China
GSK Investigational Site
Dali, China
GSK Investigational Site
Honghe, China
GSK Investigational Site
Mianyang, China
GSK Investigational Site
Mianyang, China
GSK Investigational Site
Nanbu-Nanchong, China
GSK Investigational Site
Neijiang, China
GSK Investigational Site
Tengchong, China
...and 2 more locations
Percentage of Participants With Anti-rotavirus (RV) Immunoglobulin A (IgA) Antibody (Ab) Seroconversion Rate
Seroconversion rate is defined as the percentage of participants who were initially seronegative (i.e., with anti-RV IgA Ab concentration below \[\<\] 20 unit per milliliter \[U/mL\] prior the first dose of study intervention) and developed anti-RV IgA Ab concentration greater than or equal to (\>=) 20 U/mL at Month 2 (1-month post-Dose 2).
Time frame: At Month 2 (1-month post-Dose 2)
Serum Anti-RV IgA Ab Concentrations Expressed as Geometric Mean Concentrations (GMCs)
Time frame: At Month 2 (1-month post-Dose 2)
Percentage of Participants With Serum Anti-RV IgA Ab Concentrations >= 90 U/mL
Time frame: At Month 2 (1-month post-Dose 2)
Number of Participants Reporting Solicited Systemic Events
Solicited systemic events include fever/pyrexia, diarrhoea, vomiting, irritability/fussiness, loss of appetite, cough/runny nose. Fever is defined as body temperature \>= 37.5 degrees Celsius (°C) and the preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Time frame: Within 14 days (the day of vaccination and 13 subsequent days) after each vaccination (occurring at Day 1 and Month 1)
Number of Participants Reporting Unsolicited Adverse Events (AEs)
Unsolicited AEs include any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. Any = occurrence the event regardless of intensity grade or relation to the study vaccination
Time frame: Within 31 days (the day of vaccination and 30 subsequent days) after each vaccination (occurring at Day 1 and Month 1)
Number of Participants Reporting Serious Adverse Events (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or in other situations that are considered serious as per medical or scientific judgment. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination.
Time frame: From Day 1 to Month 7
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