Ignite Creation Date:
2024-07-17 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494475
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
GBS-NNNN2 50 µg of Each Fusion Protein GBS-NN and GBS-NN2 in Combination With 500 µg Aluminum as Alhydrogel Given With and Without the Tdap Vaccine in Healthy Non-pregnant Women 18 to 49 Years of Age
Sponsor:
Minervax ApS
Organization:
Minervax ApS
Study Overview
Official Title:
A Randomised Observer-Blind Trial to Evaluate the Immunogenicity Safety and Reactogenicity of a Group B Streptococcus Vaccine GBS-NNNN2 When 1 Dose is Administered Concomitantly With the Tdap Vaccine in Healthy-non Pregnant Women 18 to 49 Years of Age Compared to When Each Vaccine is Administered Alone
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
The main objectives of the study are to demonstrate the non-inferiority of the immune response induced by co administered GBS-NNNN2 and tetanus diphtheria and acellular pertussis Tdap compared to the separate administration of GBS-NNNN2 and Tdap to evaluate the reactogenicity of GBS NNNN2 when administered alone or in combination with Tdap and to evaluate the safety of GBS-NNNN2 when administered alone or in combination with Tdap in terms of serious adverse events SAEs and unsolicited adverse events AEs
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-508563-73-00 | CTIS | None | None |
| U1111-1300-2150 | OTHER | None | None |