Serological Survey on Monitoring the Positive Rate After Vaccination of Inactivated Polio Vaccine
NCT ID: NCT02643446
Last Updated: 2017-08-01
Study Results
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Basic Information
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COMPLETED
809 participants
OBSERVATIONAL
2015-08-31
2017-07-31
Brief Summary
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Detailed Description
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1. To evaluate the seroprotection rates after the 3 doses of primary polio vaccination among age eligible children in pilot areas where the IPV was introduced into NIP;
2. To evaluate the seroprotection rates after different dose(s) of polio vaccine(s) using sequential schedule.
Sample size:752
1. Jilin shall select 120 subjects to collect blood samples for evaluation of immune response,of whom 90 will be given OPV as second vaccine and 30 will be given IPV as second vaccine
2. Hubei shall select 132 subjects to collect blood samples for evaluation of immune response,of whom 102 will be given OPV as second vaccine and 30 will be given IPV as second vaccine
3. Ningxia shall select 260 subjects to collect blood samples for evaluation of immune response. The subject will be divided into 5 groups.
4. In Guangdong province,120 children will be selected as subjects , of whom 80 children will be given OPV as first vaccine and 40 children will be given IPV as first vaccine.
5. Tianjin shall select 120 subjects to collect blood samples for evaluation of immune response, of whom 80 will be given OPV as second vaccine and 30 will be given IPV as second vaccine
Organization Chart of the Study:
* Chinese Centers for Disease Control and Prevention (China CDC) lead the overall study, and be responsible for the study design, supervise the five selected provinces, conduct field monitor, data analysis and result distribution and explanation.
* The five pilot Provincial CDCs conduct the supervision and monitoring of 1-2 counties CDCs in each of pilot province.
* The County CDCs organize several vaccination clinics to recruit the subjects who meet the Inclusion criteria.
Quality Assurance Plan:
* China CDC and provincial CDC will monitor and supervise the field work, ensure the quality of the study.
* County CDCs organize vaccination clinics to service the subjects receiving timely polio vaccines in accordance with the immunization schedule, and that the blood samples are collected in accordance with the required timeline in difference groups.
* Clinic doctors will communicate and explain the purpose and procedure of the survey to parents, and the signed informed consent from by parents will be obtained before the children participate the study.
* The target drop-out rate of subjects without the second blood samples in each province should be less than 10%.
* The samples will be tested for polio antibody in a qualified laboratory, which should be a World Health Organization certified polio network laboratory in China.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
IPV
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
OPV
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.
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.
IPV
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
OPV
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.
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.
IPV
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
OPV
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.
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.
IPV
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
OPV
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.
G5: OPV, 3 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 5 months of age, that is one month after the third dose of OPV.
OPV
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.
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.
OPV
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.
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.
OPV
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.
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.
IPV
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
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.
IPV
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
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.
IPV
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
OPV
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.
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.
IPV
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
OPV
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.
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.
IPV
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
Interventions
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IPV
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
OPV
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.
Eligibility Criteria
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Inclusion Criteria
* Receiving the polio vaccination at 2, 3 and 4 months old with an interval of 28-35 days between doses according to national immunization schedule. The first dose of vaccine was administered at 2 full months old and less than 3 full months old.
* No rotavirus vaccine was administered during the period of primary polio vaccinations, and no vaccines of category 2 (private market) were administered simultaneously with polio vaccine. If vaccines of category 2 other than rotavirus vaccine were administered, they should be administered with a space of at least 2 weeks with polio vaccination.
Exclusion Criteria
* Children didn't get proper type and doses of vaccine as the protocal required.
* Children with known immunodeficiency conditions.
* Immunosuppressive agents or blood products were used after birth.
* Vaccine contraindications.
2 Months
6 Months
ALL
Yes
Sponsors
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World Health Organization
OTHER
Tianjin Center for Disease Control and Prevention
UNKNOWN
Jilin Center for Disease Control and Prevention
UNKNOWN
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
Centers for Disease Control and Prevention, China
OTHER_GOV
Responsible Party
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Huaqing Wang
Deputy Director, National Immunization Program, China CDC
Principal Investigators
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Huaqing Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centers for Disease Control and Prevention, China
Zhijie An, MD, MPH
Role: STUDY_DIRECTOR
Centers for Disease Control and Prevention, China
Zijian Feng, MD, MPH
Role: STUDY_CHAIR
Centers for Disease Control and Prevention, China
Locations
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Guangdong Center for Disease Control and Prevention
Guangzhou, Guangdong, China
Hubei Center for Disease Control and Prevention
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
Countries
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References
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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.
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.
Other Identifiers
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201526
Identifier Type: -
Identifier Source: org_study_id
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