Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04576910
Status:
COMPLETED
Last Update Posted:
2022-03-07
First Post:
2020-09-18
Brief Title:
Immunogenicity and Safety of the Booster Dose of Polio Vaccine With Different Primary Sequential Schedules in China
Sponsor:
Zhejiang Provincial Center for Disease Control and Prevention
Organization:
Zhejiang Provincial Center for Disease Control and Prevention
Study Overview
Official Title:
Immunogenicity and Safety of the Booster Dose of Polio Vaccine Immunization Using Sabin IPV or bOPV at Children Aged 4 Years With Different Three Sequential Schedules History by Sabin IPV or bOPV in China
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is to evaluate the immunogenicity and safety of Sabin IPV or bOPV given as a booster vaccination in children aged 4 years who were previously immunised with different sequential immunization history by Sabin IPV and bOPV and to observe the antibody persistence three years after different primary sequential immunization with Sabin IPV or bOPV at age 2 3 and 4 months
Detailed Description:
This is a continuous study of preliminary trial Immunogenicity of three sequential schedules with Sabin inactivated poliovirus vaccine and bivalent oral poliovirus vaccine in Zhejiang China NCT03147560 The investigators will follow up previous participants at age 4 years old with different primary sequential immunization schedules at age 2 3 and 4 months sIPV-bOPV-bOPV sIPV-sIPV-bOPV or sIPV-sIPV-sIPV and give the 4th doses of polio vaccine with Sabin IPV or bOPV A pre-vaccination blood sample is taken for polio antibody determinations Sabin IPV will be administrated for participants in the previous Group 1 sIPV-bOPV-bOPV and Sabin IPV or bOPV will be given for participants in the previous Group 2 sIPV-sIPV-bOPV and Group 3 sIPV-sIPV-sIPV after they were randomly divided into two subgroups At least two active surveillance visits during which staff visited the participants s at home on days 3 and 30 will required after vaccination to collect adverse reaction data Parents or legal guardians were instructed to contact investigators if they observed any possible vaccine-related adverse events or important medical events such as serious illness physical disability or death The second blood sample will be collected 28-60 days after the booster vaccination The investigators will asess the immunogenicity by seroconversion rate and seropositivity after the booster vaccination and evaluate the antibody persistence using seropositive rate and GMT in participants before the booster vaccination Safety will assessed with the occurrence of adverse events reported across the study groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None