Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621654
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-29
Brief Title:
Clinical Trial of Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Partially Blinded Positively Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine in a Population Aged 2 Months and Older
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is a randomized partially blinded positively controlled phase I clinical study A total of 160 persons aged 18-59 years 1-5 years 6-11 months and 2 months 60-89 days will be recruited into the trial and the enrollment will be done according to the progression of age groups from the oldest to the youngest and the initial safety assessment will be conducted on the 8th day after the first dose of vaccination for each age group and the next group will be enrolled only after the safety is confirmed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None