Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-01 @ 2:59 PM
Study NCT ID:
NCT06970756
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-18
First Post:
2025-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Clinical Study to Evaluate the Safety of PCV26 in Individuals ≥60
Sponsor:
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Organization:
Study Overview
Official Title:
A Phase I, Randomized, Double-blind, Parallel-controlled Clinical Study to Evaluate the Safety of a 26-valent Pneumococcal Conjugate Vaccine in Individuals Aged 60 and Above
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
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 Phase I, randomized, double-blind, parallel-controlled study is to be conducted in healthy adults aged 60 and above. Participants will be randomly assigned in a 1:1 ratio to receive either 26-valent Pneumococcal Conjugate Vaccine (PCV26) or the comparator (PCV13) on Day 1 (Visit 1). Solicited adverse events (AEs) will be collected for 7 days post-vaccination and unsolicited AEs for 28 days post-vaccination, with safety data limited to serious adverse events (SAEs), and newly diagnosed chronic medical conditions (NDCMCs) collected up to 6 months post-vaccination.
Detailed Description:
None
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?: