Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety of sIPVs of different dosages in adults, children and infants in a phase I open-label study, and then assess its immunogenicity and safety in healthy infants between 60 and 90 days old in a phase II blind, randomized, and controlled study.
This study is a combination of phases I and II. Phase I study is open-label, and only collect safety information of the investigational sIPVs in adults, children and infants. Phase II study is double-blind, randomized, controlled study of the immunogenicity and safety of the investigational vaccines and two other commercialized inactivated poliovirus vaccines in healthy infants.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I Adult Group - High dosage | Experimental |
|
|
| Phase I Adult Group - Medium dosage | Experimental |
|
|
| Phase I Child Group - High dosage | Experimental |
|
|
| Phase I Child Group - Medium dosage | Experimental |
|
|
| Phase I Infant Group - High dosage | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-dose regimen of high dosage investigational sIPV | Biological | The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd.. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The seroconversion rates (SCRs) of each group of the phase II trial after three-dose regimen | Subjects whose pre-immune antibody level < 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted. | 90 days |
| The post-immune geometric mean titer (GMT) of each group of the phase II trial after three-dose regimen | GMT of each group of the phase II trial 30 days after three-dose regimen which lasts 60 days. | 90 days |
| The geometric mean fold increase (GMI) of each group after three-dose regimen | The GMI is the increase of post-immune GMT from pre-immune GMT. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| The incidences of solicited adverse events (AEs) of each group in both phase I and II trials | Solicited AEs occurred within 7 days after each injection will be collected. | 7 days |
| The incidences of unsolicited adverse events (AEs) of each group in both phase I and II trials |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Breast feeding, pregnant, or expected to conceive in the next 60 days;
History of allergy to any vaccine, or any ingredient of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
Autoimmune disease or immunodeficiency/immunosuppressive;
serious chronic diseases, serious cardiovascular disease, hypertension or diabetes that cannot be stabilized by medication, liver or kidney disease, malignancy, etc;
severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
History of thyroidectomy, asplenia, functional asplenia, or any condition resulting in the absence or removal the spleen;
Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder) , or significant bruising or coagulopathy;
Long term history of alcoholism or drug abuse;
Receipt of any of the following products:
Acute illness or acute exacerbation of chronic disease within the past 7 days;
Axillary temperature > 37.0 °C;
Infant participants with prior vaccination of poliovirus;
Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yuemei Hu | Jiangsu Province Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pizhou City Center for Disease Control and Prevention | Xuzhou | Jiangsu | 221300 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30249424 | Derived | Chu K, Ying Z, Wang L, Hu Y, Xia J, Chen L, Wang J, Li C, Zhang Q, Gao Q, Hu Y. Safety and immunogenicity of inactivated poliovirus vaccine made from Sabin strains: A phase II, randomized, dose-finding trial. Vaccine. 2018 Oct 29;36(45):6782-6789. doi: 10.1016/j.vaccine.2018.09.023. Epub 2018 Sep 21. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Phase I Infant Group - Medium dosage | Experimental |
|
|
| Phase I Infant Group - Low dosage | Experimental |
|
|
| PhaseⅡExperimental Group - High dosage | Experimental |
|
|
| PhaseⅡExperimental Group - Medium dosage | Experimental |
|
|
| PhaseⅡExperimental Group - Low dosage | Experimental |
|
|
| PhaseⅡControl Group -commercialized sIPV | Active Comparator |
|
|
| PhaseⅡ Control Group -commercialized IPV | Active Comparator |
|
|
| Single-dose regimen of medium dosage investigational sIPV | Biological | The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd.. |
|
| Three-dose regimen of high dosage investigational sIPV | Biological | The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd.. |
|
| Three-dose regimen of medium dosage investigational sIPV | Biological | The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd.. |
|
| Three-dose regimen of low dosage investigational sIPV | Biological | The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd.. |
|
| Three-dose regimen of commercialized sIPV | Biological | The control vaccine was manufactured by Chinese Academy of Medical Sciences. |
|
| Three-dose regimen of commercialized IPV | Biological | The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO). |
|
Unsolicited AEs occurred within 30 days after each injection will be collected. |
| 30 days |
| The incidences of serious adverse events (SAEs) of each group in both phase I and II trials | SAEs occurred within 30 days after each injection will be collected. | 30 days |
| 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 |
Not provided
Not provided