Safety of Sabin Inactivated Poliovirus Vaccine in Adults, Children and Infants and Lot Consistency Immunogenicity, and Safety of the msIPV in 2 Months Old Infants
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      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/dose)(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.
    

Detailed description: 
      This study includes two stages.A clinical trial with a open-label to evaluate the safety of
      Sabin Inactivated Poliovirus Vaccine (Vero cell) (2.5ml/dose)(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 stageⅡ. 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-person sIPV control group) according to the ratio of 1:1:1:1:1. Subjects in 3
      experimental groups will receive 5-person sIPV produced by Sinovac for three lots,subjects in
      IPV control group will receive IPV produced by Pasteur, and subjects in single-person sIPV
      control group will receive single-person sIPV produced by Sinovac.All subjects will received
      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.
    

Intervention name(s): Experimental vaccine; IPV control vaccine; single-person sIPV control vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 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.; 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.
Other intervention name(s): msIPV
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention