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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dosage experimental group | Experimental | Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses |
|
| Medium-dosage experimental group | Experimental | Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses |
|
| High-dosage experimental group | Experimental | Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses |
|
| Control wIPV group | Active Comparator | Three doses of control wIPV, vaccinated within one-month interval between doses |
|
| Control sIPV group | Active Comparator | Three doses of control sIPV, vaccinated within one-month interval between doses |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Immunity index of seroconversion rate | 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) | One month after three doses of vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunity index of geometric mean titer (GMT) | 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) | One month after three doses of vaccination |
| Immunity index of geometric mean ratio (GMR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuemei Hu, Bachelor | Jiangsu Province Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pizhou Center for Disease Control and Prevention | Pizhou | Jiangsu | 221300 | China |
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|
| Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses | Biological | Antigen content: 15, 45, and 45 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose |
|
| Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses | Biological | 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 |
|
| Three doses of control wIPV, vaccinated within one-month interval between doses | Biological | Antigen content: 40, 8, and 32 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose |
|
| Three doses of control sIPV, vaccinated within one-month interval between doses | Biological | Antigen content: 30, 32, and 45 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose |
|
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) |
| One month after three doses of vaccination |
| Immunity index of seropositivity rate | 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) | One month after three doses of vaccination |
| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
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