Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06183216
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2023-12-13
Brief Title:
A Phase 1b Clinical Trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
Sponsor:
Sinovac Research and Development Co Ltd
Organization:
Sinovac Biotech Co Ltd
Study Overview
Official Title:
A Randomized Double Blinded Positive Controlled Phase Ⅰb Clinical Trial in Participants Aged 2 Months 42-89 Days and 2 to 5 Years to Evaluate the Safety and Immunogenicity of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
Status:
RECRUITING
Status Verified Date:
2023-12
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:
A phase 1b clinical trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine PCV13 developed by Sinovac Life Science Co Ltd will be conducted in children aged 2 months 42-89 days and 2 to 5 years The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV13 The trial is a randomized double blinded positive controlled study
Detailed Description:
A phase Ⅰb clinical trial of the study of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine PCV13 developed by Sinovac Life Science Co Ltd Sinovac will be conducted in Chinese children aged 2 months 42-89 days and 2 to 5 years The trial is an randomized double-blind and active controlled study The objective of this study is to evaluate the safety and immunogenicity of PCV13 manufactured by Sinovac Life Science Co Ltd The active control vaccine is the PREVNAR 13 manufactured by Pfizer Inc A total of 140 participants will be enrolled including 70 children aged 2-5 years old and 70 infants aged 2 months 42-89 days Participants will be randomized to receive either Sinovac PCV13 or Pfizer PCV13 in a 11 ratio Children aged 2-5 years old will receive 1 dose Infants aged 2 months will receive 4 doses including 3 doses two-month interval in primary vaccination and a booster dose at the age of 12-15 months
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?:
None