Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399003
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-04-30
Brief Title:
Comparison Study of SIBPs MMR Vaccine Versus GSK MMR Vaccine in Children Aged 9-11 Months
Sponsor:
Shanghai Institute Of Biological Products
Organization:
Shanghai Institute Of Biological Products
Study Overview
Official Title:
A Phase III Multi-Center Randomized Observer-Blind Active Controlled Non-Inferiority Study to Evaluate the Immunogenicity and Safety of SIBPs MMR Vaccine Compared to GSK MMR Vaccine in Children 9-11 Months of Age
Status:
RECRUITING
Status Verified Date:
2024-10
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:
To evaluate the Immunogenicity and Safety of Shanghai Institute of Biological Products Co Ltds Measles Mumps and Rubella MMR Vaccine Compared to a Licensed and WHO Prequalified GSK MMR Vaccine in Healthy African Children 9-11 Months of Age
Detailed Description:
This study is designed as a phase III multi-center randomized observer blind active controlled non-inferiority study enrolling 1200 healthy African children between the ages of 9-11 months The enrolled children will be randomized to three groups in the ratio of 111 400 children in each group receiving a single dose of SIBP MMR vaccine alone at 1st dose on D1 and licensed YF vaccine alone at 2nd dose on D43 Group 1 MMR1YF2 or a single dose of GSK MMR vaccine alone at D1 Group 2 GSK MMR1 or a single dose of SIBP MMR vaccine co-administered with YF vaccine on D1 Group 3 MMR1YF1 This study will have an observer-blinded phase for Group 1 and Group 2 followed by an open label phase from Day 43 Group 3 will remain an open label arm throughout the period of the study
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