Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654700
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-22
Brief Title:
Phase III Clinical Trial of Lot-to-lot Consistency of Recombinant Herpes Zoster Vaccine CHO Cell
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Phase III Clinical Trial to Evaluate the Lot-to-lot Consistency of Three Consecutive Batches of Recombinant Herpes Zoster Vaccine CHO Cell Produced At a Commercial Scale in Subjects Aged 40 Years and Older
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
To evaluate the lot-to lot consistency of three batches of recombinant herpes zoster vaccine CHO cell produced on a commercial scale in subjects aged 40 years and older after receiving 2 doses on a 0 2 month schedule
Detailed Description:
A total of 1200 subjects aged 40 years and older were randomly assigned in a 111 ratio to three commercial-scale batches batch 1 batch 2 Batch 3 with 400 subjects in each group To demonstrate lot-to-lot consistency in terms of anti-gE antibody GMC between three production lots of the HZ vaccine one month after the second dose
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