Serological Survey on Monitoring the Positive Rate After Vaccination of Inactivated Polio Vaccine — IPV  

Poliomyelitis Clinical Trial

Official title: Serological Survey on Monitoring the Population Immunity and Positive Rate After Vaccination of Inactivated Poliovirus Vaccine

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Poliomyelitis

• NCT number: NCT02643446
• Study type: Observational
• Source: Centers for Disease Control and Prevention, China
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Completion date: July 2017