Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-30 @ 3:39 AM
Study NCT ID:
NCT00443157
Status:
COMPLETED
Last Update Posted:
2018-08-29
First Post:
2007-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Meningococcal B Vaccination in University Students
Sponsor:
Public Health England
Organization:
Study Overview
Official Title:
A Phase II, Open Label, Randomised, Single Centre Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Three or Four Doses of Meningococcal Serogroup B Outer Membrane Vesicle (OMV) Vaccine MENZBTM When Administered to Healthy Adults (University Students)
Status:
COMPLETED
Status Verified Date:
2007-09
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:
MNB3
Brief Summary:
This study is the third in a series using the MenB vaccine from the National Institute of Public Health in Norway (NIPH). The vaccine was first made in response to a high incidence of disease using the 44/76 strain which was resopnsible for most of the disease there. The VEC did the first study, MNB1, using this vaccine. Since then the NIPH has formed a commercial partnership with Chiron Vaccines and has reformulated the vaccine using the NZ98/254 MenB strain for use in New Zealand.
The vaccine was first produced at NIPH facilties and it was this vaccine that was used in our second study, MNB2. The current study, MNB3, will use the NZ98/254 MenB vaccine but from Chiron facilities where production has been scaled up in order to provide enough doses for the national immunisation campaign that is ongoing in New Zealand.
The vaccine was first produced at NIPH facilties and it was this vaccine that was used in our second study, MNB2. The current study, MNB3, will use the NZ98/254 MenB vaccine but from Chiron facilities where production has been scaled up in order to provide enough doses for the national immunisation campaign that is ongoing in New Zealand.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: