Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05870618
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-23
First Post:
2023-05-12
Brief Title:
Immunogenicity and Safety of DTaP or DT Vaccine in 6 Year Old Children
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 Adsorbed Diphtheria Tetanus Acellular Pertussis Combined Vaccine or Adsorbed Diphtheria Tetanus Combined Vaccine in 6 Years Old Childrena Randomized Controlled Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
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:
DTaPDT
Brief Summary:
This study is to evaluate the immunogenicity and safety of DTaP or DT given in children aged 6 years
Detailed Description:
A phase 4 trial was conducted in Zhejiang Province aimed to evaluate the immunogenicity and safety of DTaP or DT in children aged 6 years DTaP and DT are produced by Wuhan Biological Products Co LTD Participants will be recruited and randomly divided into two groups to receive DTaP or DT in 11 ratio Two blood samples were taken on Day 0 pre-vaccination and Day 2842 after-vaccination for test antibody against pertussis diphtheria and tetanus Adverse events and serious adverse events were actively collected by staff within 28 days of vaccination
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