The purpose of this study is to evaluate the immune response and safety of the inactivated poliovirus (IPV) vaccine when co-administered with the human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in healthy Chinese infants 6-10 weeks of age at the time of study enrolment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
400
2 doses of HRV PCV-free vaccine are administered orally at Month 0.5 and Month 1.5 (Co-administration Group) and at Day 1 and Month 1 (Staggered Group), according to the immunization schedule for HRV vaccine licensed outside of China. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.
3 doses of IPV vaccine are administered intramuscularly at Month 0.5, Month 1.5 and Month 2.5 (Co-administration Group and Staggered Group), according to the recommended schedule for vaccination against poliovirus in China.
GSK Investigational Site
Mianyang, China
GSK Investigational Site
Neijiang, China
GSK Investigational Site
Wenshan, China
GSK Investigational Site
Wenshan, China
GSK Investigational Site
Percentage of Participants With Seroconversion for Anti-poliovirus Types 1, 2 and 3 Neutralizing Antibody (Ab)
Seroconversion for anti-poliovirus types 1, 2 and 3 neutralizing Ab is defined as: - Ab titer greater than or equal to (\>=) 1:8 at 1 month after the 3 dose primary vaccination schedule of IPV in participants with Ab titer lower than (\<) 1:8 at pre-vaccination, \>= 4-fold increase in Ab titer at 1 month after the 3 dose primary vaccination schedule of IPV in participants with Ab titer \>= 1:8 at pre-vaccination.
Time frame: At Month 3.5 (1 month post-Dose 3 of IPV)
Geometric Mean Titers (GMTs) of Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab
Time frame: At Month 3.5 (1 month post-Dose 3 of IPV)
Percentage of Participants With Anti-poliovirus Types 1, 2 and 3 Neutralizing Ab Titers >=1:8 and >=1:64
Time frame: At Month 3.5 (1 month post-Dose 3 of IPV)
Percentage of Participants With Seroconversion for Anti-rotavirus (RV) Immunoglobulin A (IgA) Ab
Seroconversion for anti-RV IgA Ab is defined as: anti-RV IgA Ab concentration \>= 20 unit per milliliter (U/mL) at 1 month post-Dose 2 of HRV PCV-free vaccine, in participants who were initially seronegative (i.e., with anti-RV IgA Ab concentration \< 20 U/mL prior to the first dose of HRV PCV-free vaccine).
Time frame: At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group)
Geometric Mean Concentrations (GMCs) of Anti-RV IgA Ab
Time frame: At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group)
Percentage of Participants With Anti-RV IgA Ab Concentrations >= 90 U/mL
Time frame: At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group)
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Yuechi-Guang'an, China
Number of Participants Reporting Any Solicited Systemic Events
Solicited systemic events include cough/runny nose, diarrhoea, fever (pyrexia), irritability/fussiness, loss of appetite and vomiting. 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 after Dose 1 & 2: HRV PCV-free vaccine administered at Day 1 & Month 1 (Staggered group) and at Month 0.5 & Month 1.5 (Co-administration group); IPV administered at Month 0.5 & Month 1.5 (Staggered and Co-administration group)
Number of Participants Reporting Any 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 after each dose of HRV PCV-free vaccine (administered at Day 1 and Month 1 for Staggered Group and at Month 0.5 and Month 1.5 for Co-administration group)
Number of Participants Reporting Any 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 per medical or scientific judgment. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Time frame: From the first dose of the study intervention (Day 1 for Staggered group and Month 0.5 for Co-administration group) up to study end (Month 3.5)