Poliomyelitis
Conditions
Brief 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-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.
Detailed description
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.
Interventions
BIOLOGICALExperimental vaccine
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.
BIOLOGICALIPV control vaccine
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.
BIOLOGICALsingle-person sIPV control vaccine
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.
Sponsors
Sinovac Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
The clinical trial is divided into two stages: the first stage is an open design, and the second stage is a randomized ,blind control design
Eligibility
Sex/Gender
ALL
Age
2 Months to 49 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria for adult subjects : * Healthy adults aged 18-49 days; * Proven legal identification; * The subject can understand and voluntarily sign the informed consent form. Inclusion criteria for children subjects : * Healthy children aged 4 years old; * Subjects who have completed primary immunization with 3 doses of sIPV vaccine; * Proven legal identification and vaccination certificate; * The subject and/or guardian can understand and voluntarily sign the informed consent form. Inclusion criteria for infant subjects: * Healthy infants aged 2 months (60\ 89 days) * Proven legal identification and vaccination certificate; * The subject and/or guardian can understand and voluntarily sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety index-incidence of adverse reactions | Within 30 days after each dose | Incidence of adverse reactions within 30 days after each dose |
| Immunogenicity index-Geometric mean titers (GMT) | 30 days after primary immunization | GMT 30 days after primary immunization in msIPV vaccination group |
| Immunogenicity index- seroconversion rate of neutralizing antibody | 30 days after primary immunization | Seroconversion rate of neutralizing antibody 30 days after primary immunization in combined experiment group and IPV control group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity index- Neutralizing antibody positive rate | Before booster dose | Neutralizing antibody positive rate, percentage of subjects with antibody ≥1:64 and GMT before booster dose |
| Safety index-incidence of adverse reactions | Within 7 days after each dose | Incidence of adverse reactions within 7 days after each dose |
| Immunogenicity index-Neutralizing antibody positive rate,GMT and GMI | 30 days after booster dose | Neutralizing antibody positive rate, percentage of subjects with antibody ≥1:64, GMT and GMI 30 days after booster dose |
| Safety index-the incidence of adverse reactions | During the period of safety monitoring | Incidence of SAE during the period of safety monitoring |
| Immunogenicity index- Neutralizing antibody positive rate and GMI | 30 days after primary immunization | Neutralizing antibody positive rate and GMI and percentage of subjects with antibody ≥1:64 30 days after primary immunization |
Countries
China
Outcome results
None listed