Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531538
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
A Study to Learn About How a New Pneumococcal Vaccine Works in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A PHASE 2 RANDOMIZED PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY TOLERABILITY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE ADMINISTERED IN HEALTHY TODDLERS 12 THROUGH 15 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:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to learn about the safety tolerability and immune effects of a pneumococcal vaccine in toddlers
Participants will take part in this study for approximately 6 or 8 months depending on which group they are assigned to During this time participants will have 2 clinic visits and 1 phone visit for the 1-Dose group or 3 clinic visits and 1 phone visit for the 2-Dose group
At these clinic visits participants will be asked if any side effects were experienced The participants will also have to give blood samples during some clinic visits
Participants will take part in this study for approximately 6 or 8 months depending on which group they are assigned to During this time participants will have 2 clinic visits and 1 phone visit for the 1-Dose group or 3 clinic visits and 1 phone visit for the 2-Dose group
At these clinic visits participants will be asked if any side effects were experienced The participants will also have to give blood samples during some clinic visits
Detailed Description:
None
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