NCT02643446CompletedNot Applicable
Serological Survey on Monitoring the Population Immunity and Positive Rate After Vaccination of Inactivated Poliovirus Vaccine
Centers for Disease Control and Prevention, China5 sites in 1 country809 target enrollmentStarted: August 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 809
- Locations
- 5
- Primary Endpoint
- Seroconversion rate
Study Overview
Brief 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:
- 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;
- To evaluate the seroprotection rates after different dose(s) of polio vaccine(s) using sequential schedule.
Sample size:752
- 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
- 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
- Ningxia shall select 260 subjects to collect blood samples for evaluation of immune response. The subject will be divided into 5 groups.
- 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.
- 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:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 2 Months to 6 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy children who are regular residents in the pilot counties where the immune response is evaluated in pilot provinces.
- •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
- •The first dose of polio vaccine was administered at more than 3 months old regardless of the reasons.
- •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.
Outcomes
Primary Outcomes
Seroconversion rate
Time Frame: One month after the specific dose of IPV or OPV
Calculate the percentage of subjects with seroconversion after each dose of IPV or OPV vaccination
Secondary Outcomes
No secondary outcomes reported
Investigators
Huaqing Wang
Deputy Director, National Immunization Program, China CDC
Centers for Disease Control and Prevention, China
Study Sites (5)
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