Eligible,healthy infants who have finished the 3-dose-schedule of sIPV+DTaP combined vaccination clinical trial (NCT04053010) will be recruited and divided into 4 groups, and will receive vaccination at the age of 18-month-old as follows: 1. Group 1: sIPV + DTaP + HepA, 2. Group 2: sIPV only, 3. Group 3: DTaP only, 4. Group 4: HepA only. The immunogenicity and safety of the 4 groups will be compared and analyzed before and 30-40 days after vaccination.
Following the clinical trial of "Combined Immunization of sIPV and DTaP" in 2019, this study recruits 600 18-month-old subjects who have received 3 doses of sIPV + DTaP, and gives them a 4th dose of vaccination (booster immunization). They are divided into 4 different groups, with 150 subjects in each group, and are innoculated with different vaccines. To be specific, group 1 receives sIPV (0.5ml)+ DTaP (0.5ml)+ HepA(0.5ml); group 2 receives sIPV (0.5ml); group 3 receives DTaP (0.5ml); group 4 receives HepA (0.5ml). Blood samples will be collected before vaccination and 30-40 days after this booster immunization. Neutralization antibody will be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will be monitored as well.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
600
sIPV+DTaP+HepA at the age of 18 month old
sIPV at the age of 18 month old
DTaP at the age of 18 month old
Hebei Provincial Center for Disease Control and Prevention
Shijiazhuang, Hebei, China
RECRUITINGShaanxi Provincial Center for Disease Control and Prevention
Xi'an, Shaanxi, China
RECRUITINGShanxi Provincial Center for Disease Control and Prevention
Taiyuan, Shanxi, China
RECRUITINGSeroconversion rate (sIPV)
determine the rate of positive seroconversion against poliovirus type I, II and III of the subjects
Time frame: Baseline (before vaccination) results
Seroconversion rate (sIPV)
determine the rate of positive seroconversion against poliovirus type I, II and III of the subjects
Time frame: Results obtained 30-40 days after vaccination
Seroconversion rate (DTaP)
determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Time frame: Baseline (before vaccination) results
Seroconversion rate (DTaP)
determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Time frame: Results obtained 30-40 days after vaccination
Seroconversion rate (HepA)
determine the rate of positive seroconversion rate of anti-hepatitis A virus antibody of the subjects
Time frame: Baseline (before vaccination) results
Seroconversion rate (HepA)
determine the rate of positive seroconversion rate of anti-hepatitis A virus antibody of the subjects
Time frame: Results obtained 30-40 days after vaccination
Geometric Mean Concentration (GMC) (sIPV)
GMCs of poliovirus type I, II and III of the subjects
Time frame: Baseline (before vaccination) results
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HepA at the age of 18 month old
Geometric Mean Concentration (GMC) (sIPV)
GMCs of poliovirus type I, II and III of the subjects
Time frame: Results obtained 30-40 days after vaccination
Geometric Mean Concentration (GMC) (DTaP)
GMCs of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Time frame: Baseline (before vaccination) results
Geometric Mean Concentration (GMC) (DTaP)
GMCs of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects
Time frame: Results obtained 30-40 days after vaccination
Geometric Mean Concentration (GMC) (HepA)
GMCs of anti-hepatitis A virus antibody of the subjects
Time frame: Baseline (before vaccination) results
Geometric Mean Concentration (GMC) (HepA)
GMCs of anti-hepatitis A virus antibody of the subjects
Time frame: Results obtained 30-40 days after vaccination
Adverse Events Following Immunization (AEFI)
analyse the incidence of adverse events following immunization, both solicited and unsolicited
Time frame: 0-6 months