Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT05759520
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-01
First Post:
2023-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase III Clinical Trial of 13-valent Pneumococcal Conjugate Vaccine (Multivalent Conjugate) in Infants
Sponsor:
Fosun Adgenvax Biopharmaceutical Co.,Ltd.
Organization:
Study Overview
Official Title:
Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (Multivalent Conjugate) in Infants Aged 2 Months (at Least 6 Weeks) and 3 Months
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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 study is a phase III clinical trial to evaluate the immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine (multivalent conjugate) in infants aged 2 months (at least 6 weeks) and 3 months. The main objectives of the study include: 1. To evaluate the immunogenicity of the trial vaccine in infants aged 2 months (at least 6 weeks) following the corresponding immunization schedule compared to the control vaccine; 2. To evaluate the immunogenicity of the trial vaccine in infants aged 3 months following the corresponding immunization schedule compared to the 2-month group; 3. To evaluate the safety of the trial vaccine in infants aged 2 months (at least 6 weeks) and 3 months following the corresponding immunization schedule.
Detailed Description:
None
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?: