Ignite Creation Date:
2024-05-05 @ 10:42 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01168401
Status:
COMPLETED
Last Update Posted:
2018-11-23
First Post:
2010-07-21
Brief Title:
Bivalent Norovirus Vaccine Study
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
Phase 1 Randomized Controlled Dose Escalation Safety and Immunogenicity Study of Intramuscular Norovirus GI1GII4 Bivalent Virus-Like Particle VLP Vaccine Adjuvanted With Monophosphoryl Lipid A MPL and Aluminum Hydroxide AlOH3 in Adults
Status:
COMPLETED
Status Verified Date:
2018-04
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:
Randomized multi-site dose-escalation study of the safety and immunogenicity of four dosage levels of Intramuscular IM Norovirus Bivalent VLP Vaccine adjuvanted with MPL and AlOH3 compared to controls Participants will receive two doses by IM injection 28 days apart
The hypotheses for this study are
The incidence of adverse events after vaccination with IM Norovirus Bivalent VLP Vaccine will be similar to the incidence of adverse events after other IM vaccines including CERVARIX which contains MPL and AlOH3
Two doses of IM Norovirus Bivalent VLP Vaccine will be more immunogenic than one dose
The post-vaccination serum antibody responses the number of antibody secreting cells ASC including homing markers and memory B-cell responses directed against norovirus antigens will be increased after IM Norovirus Bivalent VLP Vaccine compared to controls
The hypotheses for this study are
The incidence of adverse events after vaccination with IM Norovirus Bivalent VLP Vaccine will be similar to the incidence of adverse events after other IM vaccines including CERVARIX which contains MPL and AlOH3
Two doses of IM Norovirus Bivalent VLP Vaccine will be more immunogenic than one dose
The post-vaccination serum antibody responses the number of antibody secreting cells ASC including homing markers and memory B-cell responses directed against norovirus antigens will be increased after IM Norovirus Bivalent VLP Vaccine compared to controls
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 |
|---|---|---|---|
| U1111-1187-1052 | REGISTRY | WHO | None |