Poliomyelitis
Conditions
Brief summary
This study is a supplementary study of an already finished randomised, double-blinded, and placebo controlled phase 2 clinical trial of an Sabin strain inactivated poliovirus vaccine (sIPV) manufactured by Sinovac Biotech Ltd., Beijing China. The purpose of this study is to evaluate the cross-neutralization capacity of the serum immuned by the investigational sIPV against 10 individual virus strains.
Detailed description
This study is a open-labelled study conducted based on an already finished phase 2 study of the investigational sIPV in 600 healthy infants aged 2-months old. The purpose of this study is to evaluate the cross-neutralization capacity of the serum immuned by the investigational sIPV against 10 individual virus strains. Paired pre-immune and post-immune serum from 250 participants of the phase 2 trial, with 50 in each group including the low-, medium- and high- dosage group, control wild poliovirus vaccine (wIPV) group and control sIPV group, was selected and sent to China Center for Disease Control and Prevention (CDC) for the cross-neutralization assay to determine the neutralizing antibody titer against 10 individual virus strains including Sabin strains (type 1, 2, and 3), Salk strains (Mahoney, MEF-1, and Saukett), cVDPV (type 1, 2, and 3) and Xinjiang wild strain of type 1(Xinjiang wIPV1). All the subjects in this study had been vaccinated at the schedule of month 0,1, and 2 in the phase 2 clinical trial.
Interventions
BIOLOGICALThree doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses
Antigen content: 7.5, 22.5, and 22.5 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
BIOLOGICALThree doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses
Antigen content: 15, 45, and 45 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
BIOLOGICALThree doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses
Antigen content: 22.5, 67.5, and 67.5 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
BIOLOGICALThree doses of control wIPV, vaccinated within one-month interval between doses
Antigen content: 40, 8, and 32 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
BIOLOGICALThree doses of control sIPV, vaccinated within one-month interval between doses
Antigen content: 30, 32, and 45 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
Sponsors
Sinovac Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 2 Months
Healthy volunteers
Yes
Inclusion criteria
* Participants of the already finished phase 2 clinical trial; * Subjects who received the three-doses full schedule vaccination required in the phase 2 tril and can provide the backup paired pre-immune and post-immune serum collected in the phase trial; * Provide written informed consent.
Exclusion criteria
* None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunity index of seroconversion rate | One month after three doses of vaccination | The seroconversion rates of neutralizing antibody against 10 individual virus strains (Sabin 1, Sabin2， Sabin 3, Mahoney 1, MEF-1, Saukett, cVDPV1, cVDPV2, cVDPV3, and Xinjiang wIPV1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunity index of seropositivity rate | One month after three doses of vaccination | The seropositivity rate of neutralizing antibody against 10 individual virus strains (Sabin 1, Sabin2， Sabin 3, Mahoney 1, MEF-1, Saukett, cVDPV1, cVDPV2, cVDPV3, and Xinjiang wIPV1) |
| Immunity index of geometric mean titer (GMT) | One month after three doses of vaccination | The GMT of neutralizing antibody against 10 individual virus strains (Sabin 1, Sabin2， Sabin 3, Mahoney 1, MEF-1, Saukett, cVDPV1, cVDPV2, cVDPV3, and Xinjiang wIPV1) |
| Immunity index of geometric mean ratio (GMR) | One month after three doses of vaccination | The GMR of neutralizing antibody against 10 individual virus strains (Sabin 1, Sabin2， Sabin 3, Mahoney 1, MEF-1, Saukett, cVDPV1, cVDPV2, cVDPV3, and Xinjiang wIPV1) |
Countries
China
Outcome results
None listed