Serological Survey on Monitoring the Positive Rate After Vaccination of Inactivated Polio Vaccine
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      Objective:

        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.
    

Intervention name(s): IPV; OPV
Intervention type(s): Biological; Biological
Intervention description(s): 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 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.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        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.
      
Biospecimen description: 
      Serum, Whole blood
    
Keywords: Poliovirus Vaccine, Inactivated; Poliovirus Vaccine, Oral; Immunity; Seroconversion