Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06608199
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
A Phase 3 Study to Evaluate the Immunogenicity and Safety of Minhais PCV13-DTTT Vaccine As Compared to Pfizers PCV13 Vaccine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multi-center Randomized Blinded Active-controlled Phase 3 Clinical Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine Co-administered with Hexavalent Vaccine At 2 4 and 12-15 Months of Age to Healthy Infants in Indonesia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
The goal of this clinical trial is to evaluate the immunogenicity and safety of a novel 13-valent pneumococcal polysaccharide conjugate vaccine PCV13-DTTT as compared to Pfizeramp39s 13-valent pneumococcal conjugate vaccine PCV13 when co-administered with Hexavalent Vaccines at 2 4 and 12-15 months of age to healthy infants in Indonesia This study aims to demonstrate the non-inferiority of the serotype-specific immune responses elicited by the novel PCV13-DTTT Pneuminvac as compared to PCV13Prevenar 13 one month after the booster dose
Detailed Description:
A total of approximately 500 infants 6-8 weeks of age WOA will be enrolled and randomized in 11 ratio into the study group and control group with 250 participants in each groupThe study group will receive study PCV13 vaccine and control group will receive Prevenar13 vaccine at 2 4 and 12-15 months of age MOA as early as 6 weeks of age as per WHO recommendations for administration of PCV to infants Hexavalent vaccine will be injected at 2 3 and 4 months of age
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