Ignite Creation Date:
2024-05-06 @ 2:23 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02038907
Status:
COMPLETED
Last Update Posted:
2017-08-08
First Post:
2014-01-15
Brief Title:
Safety and Immunogenicity of Norovirus GI1GII4 Bivalent VLP Vaccine
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase II Randomized Controlled Double-Blind Dosage and Adjuvant Justification Safety and Immunogenicity Trial of Intramuscular Norovirus GI1GII4 Bivalent Virus-Like Particle Vaccine Adjuvanted With or Without Monophosphoryl Lipid A and Aluminum Hydroxide in Adults
Status:
COMPLETED
Status Verified Date:
2017-08
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:
NOR-107
Brief Summary:
The purpose of this study is to select the optimal formulation of the norovirus vaccine from different concentrations of virus-like particles VLP Aluminum Hydroxide and MPL adjuvant 3-O-desacyl-4-monophosphoryl lipid A for further development
Detailed Description:
The vaccine being tested in this study is called norovirus GI1GII4 bivalent virus-like particle VLP vaccine adjuvanted with aluminum hydroxide and with or without monophosphoryl lipid A MPL The norovirus vaccine is being tested to assess different formulations of the vaccine that will then be further developed
This study will look at the number of antibodies to norovirus formed in people who take different formulations of the norovirus vaccine The study will enroll approximately 420 patients Participants will be randomly assigned by chance to one of fourteen treatment groups-which will remain undisclosed to the patient and study doctor during the study unless there is an urgent medical need
All participants will receive a vaccination on Day 1 and Day 28 of the study Some treatment arms will receive one dose of the norovirus vaccine and some arms will receive two In order to keep the treatment arms undisclosed to the patient and the doctor those randomized to the one dose groups will receive a dose of Hepatitis A vaccine on Day 1 followed by the norovirus vaccine 28 days later Participants will be asked to record any symptoms that may be related to the vaccine or the injection site in a diary card for 7 days after each vaccination
This multi-centre trial will be conducted in Belgium The overall time to participate in this study is up to 393 days Participants will make 6 visits to the clinic and will be contacted by telephone twice for follow-up assessments
This study will look at the number of antibodies to norovirus formed in people who take different formulations of the norovirus vaccine The study will enroll approximately 420 patients Participants will be randomly assigned by chance to one of fourteen treatment groups-which will remain undisclosed to the patient and study doctor during the study unless there is an urgent medical need
All participants will receive a vaccination on Day 1 and Day 28 of the study Some treatment arms will receive one dose of the norovirus vaccine and some arms will receive two In order to keep the treatment arms undisclosed to the patient and the doctor those randomized to the one dose groups will receive a dose of Hepatitis A vaccine on Day 1 followed by the norovirus vaccine 28 days later Participants will be asked to record any symptoms that may be related to the vaccine or the injection site in a diary card for 7 days after each vaccination
This multi-centre trial will be conducted in Belgium The overall time to participate in this study is up to 393 days Participants will make 6 visits to the clinic and will be contacted by telephone twice for follow-up assessments
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-001419-64 | EUDRACT_NUMBER | None | None |
| U1111-1147-3239 | OTHER | WHO | None |