Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-03-02 @ 8:36 AM
Study NCT ID:
NCT05870618
Status:
UNKNOWN
Last Update Posted:
2023-05-23
First Post:
2023-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
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 Children：a Randomized, Controlled Clinical Study
Status:
UNKNOWN
Status Verified Date:
2023-05
Last Known Status:
NOT_YET_RECRUITING
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:
DTaP/DT
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 1:1 ratio. Two blood samples were taken on Day 0 (pre-vaccination) and Day 28\~42 (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:
False
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?: