This study includes two parts.A clinical trial with a open-label to evaluate the safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) (2.5ml-5 doses)(hereinafter referred to as "msIPV")manufactured by Sinovac Biotech Co., Ltd. in adults, children and infants in partⅠ and a blinded,randomized and controlled clinical trial to evaluate the lot consistency immunogenicity, and safety of the msIPV in 2 months old infants in partⅡ.
This study includes two stages. A clinical trial with an open-label to evaluate the safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) (2.5ml-5 doses) (hereinafter referred to as "msIPV") in adults, children and infants in stageⅠ and a blinded, randomized and controlled clinical trial to evaluate the lot consistency immunogenicity, and safety of the msIPV in 2 months old infants in stage Ⅱ. A total of 1572 subjects including 24 adults aged 18-49 years,24 children aged 4 years,1524 infants aged 2 months will be enrolled. StagesⅠ:72 healthy subjects, including 24 adults,24 children and 24 infants will be enrolled. 24 adults and 24 children will receive one dose of vaccine and 24 infants will receive 4 doses of vaccine according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months. StagesⅡ:1500 infants aged 2 months will be randomly divided into 5 groups (Experimental Vaccine-lot 1, Experimental Vaccine-lot 2, Experimental Vaccine-lot 3,IPV control group and single-dose sIPV control group) according to the ratio of 1:1:1:1:1. Subjects in 3 experimental groups will receive 5-dose sIPV produced by Sinovac for three lots, subjects in IPV control group will receive IPV produced by Pasteur, and subjects in single-dose sIPV control group will receive single-dose sIPV produced by Sinovac. All subjects will receive 4 doses of experimental or control vaccine according to the primary immunization schedule of 0,1,2 months, one dose of booster at 18 months of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Sabin Inactivated Poliovirus Vaccine (Vero cell) (2.5ml)-investigational vaccine produced by Sinovac Biotech Co., Ltd. Inactivated Sabin poliovirus antigen (per 0.5ml): type 1 (15DU), type 2 (45DU), and type 3 (45DU)in 2.5 ml mixture of medium 199,glycine,formaldehyde,sodium chloride,potassium chloride,calcium chloride,magnesium sulfate,disodium phosphate,sodium dihydrogen phosphate,2 - phenoxyethanol for per injection.
Inactivated Poliovirus Vaccine - control vaccine produced by Sanofi. Inactivated poliovirus antigens: Mahoney strain for type 1 (40DU), MEF-1 strain for type 2 (8DU), Saukett strains for type 3 (32DU) in 0.5 ml mixture of 2- phenoxyethanol,ethanol,formaldehyde,hanks199 medium (containing amino acids, mineral salts, vitamins, glucose, polysorbate 80 and water for injection),hydrochloric acid or sodium hydroxide (for pH value adjustment),trace amounts of antibiotics (neomycin, streptomycin and polymyxin B)for per injection.
Xiangfu District Center for Disease Prevention and Control
Kaifeng, Henan, China
Xiangcheng County Center for Disease Control and Prevention
Xuchang, Henan, China
Safety index-incidence of adverse reactions
Incidence of adverse reactions within 30 days after each dose
Time frame: Within 30 days after each dose
Immunogenicity index-Geometric mean titers (GMT)
GMT 30 days after primary immunization in msIPV vaccination group
Time frame: 30 days after primary immunization
Immunogenicity index- seroconversion rate of neutralizing antibody
Seroconversion rate of neutralizing antibody 30 days after primary immunization in combined experiment group and IPV control group
Time frame: 30 days after primary immunization
Safety index-incidence of adverse reactions
Incidence of adverse reactions within 7 days after each dose
Time frame: Within 7 days after each dose
Safety index-the incidence of adverse reactions
Incidence of SAE during the period of safety monitoring
Time frame: During the period of safety monitoring
Immunogenicity index- Neutralizing antibody positive rate and GMI
Neutralizing antibody positive rate and GMI and percentage of subjects with antibody ≥1:64 30 days after primary immunization
Time frame: 30 days after primary immunization
Immunogenicity index- Neutralizing antibody positive rate
Neutralizing antibody positive rate, percentage of subjects with antibody ≥1:64 and GMT before booster dose
Time frame: Before booster dose
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Enrollment
1,572
Sabin Inactivated Poliovirus Vaccine (Vero cell) (0.5ml) -control vaccine produced by Sinovac Biotech Co., Ltd. Inactivated Sabin poliovirus antigen: type 1 (15DU), type 2 (45DU), and type 3 (45DU)in 0.5 ml mixture of medium 199,glycine,formaldehyde,sodium chloride,potassium chloride,calcium chloride,magnesium sulfate,disodium phosphate,sodium dihydrogen phosphate for per injection.
Immunogenicity index-Neutralizing antibody positive rate,GMT and GMI
Neutralizing antibody positive rate, percentage of subjects with antibody ≥1:64, GMT and GMI 30 days after booster dose
Time frame: 30 days after booster dose