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| Name | Class |
|---|---|
| World Health Organization | OTHER |
| Tianjin Center for Disease Control and Prevention | UNKNOWN |
| Jilin Center for Disease Control and Prevention | UNKNOWN |
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The Purpose of this study is to assess the seroconversion using inactivated poliovirus vaccine (IPV) and oral poliovirus vaccine (OPV) sequential schedule in pilot areas where IPV was phased introduced into national immunization program (NIP) in China.
Objective:
Sample size:752
Organization Chart of the Study:
Quality Assurance Plan:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G1: IPV+OPV, 1 m followup | Using 1 dose IPV and 2 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of IPV, another sample at 3 months of age, that is one month after the first dose of IPV and just before the first dose of OPV. |
| |
| G2: IPV+OPV, 1 m+7d followup | Using 1 dose IPV and 2 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of IPV, another sample at 3 months and 7 days of age, that is 7 days after the first dose of OPV. |
| |
| G3: IPV+OPV, 2 m followup | Using 1 dose IPV and 2 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of IPV, another sample at 4 months of age, that is one month after the first dose of OPV and just before the second dose of OPV. |
| |
| G4: IPV+OPV, 3 m followup | Using 1 dose IPV and 2 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of IPV, another sample at 5 months of age, that is one month after the second dose of OPV. |
| |
| G5: OPV, 3 m followup |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPV | Biological | IPV will be vaccinated at 2 months of age act as the first dose of poliovirus vaccine in the study group1 to group 4,group8 to group 11. IPV will be given at 3 month of age act as second vaccine in group 8,9,12 |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate | Calculate the percentage of subjects with seroconversion after each dose of IPV or OPV vaccination | One month after the specific dose of IPV or OPV |
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Inclusion Criteria:
Exclusion Criteria:
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The participants will be seclected from the vaccination clinics. The study will be in five provinces, which conduct the pilot project of IPV phased introduction into national immunization program. In each province, 1-2 counties will be selected, and then selected several vaccination clinics.
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| Name | Affiliation | Role |
|---|---|---|
| Huaqing Wang, MD, PhD | Centers for Disease Control and Prevention, China | Principal Investigator |
| Zhijie An, MD, MPH | Centers for Disease Control and Prevention, China | Study Director |
| Zijian Feng, MD, MPH | Centers for Disease Control and Prevention, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Center for Disease Control and Prevention | Guangzhou | Guangdong | China | |||
| Hubei Center for Disease Control and Prevention |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24634499 | Background | Grassly NC. Immunogenicity and effectiveness of routine immunization with 1 or 2 doses of inactivated poliovirus vaccine: systematic review and meta-analysis. J Infect Dis. 2014 Nov 1;210 Suppl 1(Suppl 1):S439-46. doi: 10.1093/infdis/jit601. Epub 2014 Mar 14. | |
| 23363495 | Background | Resik S, Tejeda A, Sutter RW, Diaz M, Sarmiento L, Alemani N, Garcia G, Fonseca M, Hung LH, Kahn AL, Burton A, Landaverde JM, Aylward RB. Priming after a fractional dose of inactivated poliovirus vaccine. N Engl J Med. 2013 Jan 31;368(5):416-24. doi: 10.1056/NEJMoa1202541. |
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| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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| Hubei Provincial Center for Disease Control and Prevention |
| OTHER |
| Guangdong Center for Disease Prevention and Control | OTHER_GOV |
| Ningxia Center for Disease Control and Prevention | UNKNOWN |
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Serum, Whole blood
Using 3 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of OPV, another sample at 5 months of age, that is one month after the third dose of OPV. |
|
| G6: OPV, 1 m followup | Using 3 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of OPV, another sample at 3 months of age, that is one month after the first dose of OPV and just before the second dose of OPV. |
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| G7: OPV, 1 m+7d followup | Using 3 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of OPV, another sample at 3 months and 7 days of age, that is 7 days after the second dose of OPV. |
|
| G8: IPV+IPV, 1 m+7d followup | Using 2 dose IPV and 1 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of IPV, another sample at 3 months and 7 days of age, that is 7 days after the second dose of IPV. |
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| G9: IPV+IPV, 2 m followup | Using 2 doses of IPV and 1 doses of OPV at 2, 3,4 months of age; Collecting two blood samples: one sample just before the first dose of IPV, another sample at 4 months of age, that is one month after the second dose of IPV and just before the first dose of OPV. |
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| G10: IPV+OPV, 1 m and 3 m followup | Using 1 dose IPV and 2 doses of OPV at 2, 3 and 4 months of age; Collecting three blood samples: one sample just before the first dose of IPV, another sample at 3 months of age, that is one month after the first dose of IPV and just before the first dose of OPV;the third sample at 5 months of age, that is one month after the second dose of OPV. |
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| G11: IPV+OPV, 1 m+7d and 2 m followup | Using 1 dose IPV and 2 doses of OPV at 2, 3 and 4 months of age; Collecting three blood samples: one sample just before the first dose of IPV, another sample at 3 months and 7 days of age, that is 7 days after the first dose of OPV,the third sample at 4 months of age, that is one month after the first dose of OPV. |
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| G12: IPV+IPV,1 m+7d and 2 m followup | Using 2 dose IPV and 1 doses of OPV at 2, 3 and 4 months of age; Collecting three blood samples: one sample just before the first dose of IPV, another sample at 3 months and 7 days of age, that is 7 days after the second dose of IPV,the third sample at 4 months of age, that is one month after the second dose of IPV. |
|
| OPV | Biological | OPV will be vaccinated at 3 and 4 months of age, act as the second and third dose of poliovirus vaccine in the study group 1 to group 4,group 10 to group 11. OPV will be vaccinated at 2, 3 and 4 months of age act as the full three primary immunization doses of polio virus vaccine in the study group 5 to group 7. |
|
| Wuhan |
| Hubei |
| China |
| Jilin Center for Disease Control and Prevention | Changchun | Jilin | China |
| Ningxia Center for Disease Control and Prevention | Yinchuan | Ningxia | China |
| Tianjin Center for Disease Control and Prevention | Tianjin | Tianjin Municipality | China |
| 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 |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |