Ignite Creation Date:
2024-05-06 @ 2:18 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02014168
Status:
TERMINATED
Last Update Posted:
2014-04-30
First Post:
2013-11-08
Brief Title:
Safety and Immunogenicity of Co-administration of Candidate Influenza Vaccine MVA-NPM1 and Viroflu Seasonal Influenza Vaccine
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
A Phase I Study to Determine the Safety and Immunogenicity of Co-administration of the Candidate Influenza Vaccine MVA-NPM1 and the Viroflu Seasonal Influenza Vaccine
Status:
TERMINATED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single blinded placebo controlled phase I study to assess the safety and immunogenicity of co-administration of the candidate influenza vaccine MVA-NPM1 with the Viroflu seasonal influenza vaccine All volunteers recruited will be healthy adults aged 18 and over
Detailed Description:
This study is designed to test the safety and effectiveness of a combination of two vaccines for influenza One of these vaccines will be the seasonal influenza vaccine Viroflu Inflexal V The second will be an investigational viral vectored vaccine called MVA NPM1 The rationale for combining these two vaccines is that they work differently and that by combining the two vaccines stronger and broader immune responses may be produced
The MVA NPM1 vaccine has been evaluated in five previous clinical trials In total over 80 volunteers have received this vaccine There have been no vaccine related serious adverse events Higher doses of MVA NPM1 are more reactogenic however at the dose to be used in this study the majority of adverse events are mild
20 volunteers will be recruited in this study They will all be adults over the age of 18 Volunteers will be assigned to one of two groups Volunteers in group 1 will receive Viroflu followed by a dose of MVA NPM1 Volunteers in group 2 will receive Viroflu followed by a placebo injection saline Volunteers will be blinded so that they do not know which group they have been allocated to and will be asked to complete diary cards listing any adverse events after vaccination
Vaccinations will be administered into the thigh as the deltoid muscle is not normally large enough to accept two intramuscular injections
Volunteers will followed up for 6 months in total Two days after vaccination they will receive a telephone call from one of the clinical team They will then attend three follow up visits at weeks 1 3 and 26 At each visit volunteers will have blood tests taken and will be questioned about any adverse events they may have experienced
The MVA NPM1 vaccine has been evaluated in five previous clinical trials In total over 80 volunteers have received this vaccine There have been no vaccine related serious adverse events Higher doses of MVA NPM1 are more reactogenic however at the dose to be used in this study the majority of adverse events are mild
20 volunteers will be recruited in this study They will all be adults over the age of 18 Volunteers will be assigned to one of two groups Volunteers in group 1 will receive Viroflu followed by a dose of MVA NPM1 Volunteers in group 2 will receive Viroflu followed by a placebo injection saline Volunteers will be blinded so that they do not know which group they have been allocated to and will be asked to complete diary cards listing any adverse events after vaccination
Vaccinations will be administered into the thigh as the deltoid muscle is not normally large enough to accept two intramuscular injections
Volunteers will followed up for 6 months in total Two days after vaccination they will receive a telephone call from one of the clinical team They will then attend three follow up visits at weeks 1 3 and 26 At each visit volunteers will have blood tests taken and will be questioned about any adverse events they may have experienced
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 |
|---|---|---|---|
| 2013-003569-32 | EUDRACT_NUMBER | None | None |