Expression of Interest (Eol)
Development of pandemic influenza vaccines.
Application Form
Disclaimer:
This is the application form template for the Expression of Interest (Eol) for vaccine developers, who are currently developing a vaccine against pandemic influenza and who are willing to explore potential collaboration with the European Vaccines Hub (EVH). Instructions are presented in
italics
. Before submission, please delete this disclaimer and all other guideline text (
italics
) throughout this document. Please keep the headings in bold under each section.
Expression of Interests (EOI) can be submitted any time and will be evaluated by the EVH Influenza Working Group and by the EVH Steering Committee. A feedback will be provided to applicants on the potential of the collaboration and opportunity to engage further discussion.
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Contact information
Company/Institution name:
*
Web page:
Name of the main contact:
*
Email of main contact:
*
example@example.com
Country of headquarters:
*
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1. General Information
Vaccine name:
*
Type of vaccine platform:
*
Vaccine dose regimen:
*
Max 100 words
0/100
Route(s) of vaccine administration
*
Intramuscular
Intranasal
Inhaled
Oral
Intradermal
Other
Device needed for vaccine administration?
*
Yes
No
If applicable describe device included intended use:
*
Max 200 words
0/2
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2. Preclinical & Clinical Development
Most advanced stage of development
*
Pre-clinical
GMP
Phase I
Phase II
Phase III
Licensed
Investigator Brochure (IB) (final version) in place?
*
Yes
No
When will be available?
/
Day
/
Month
Year
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Phase I CSR (final & signed) in place?
*
Yes
No
When it will be available?
/
Day
/
Month
Year
Date Picker Icon
Phase Il CSR (final & signed) in place?
*
Yes
No
When it will be available?
/
Day
/
Month
Year
Date Picker Icon
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CLINICAL QUESTIONS
Has any vaccine and/or device related SAE been observed?
*
Yes
No
Not Applicable
Please provide high level information
Max 250 words
0/250
Is data available on efficacy?
*
Yes
No
(Optional) Vaccine efficacy (%) observed:
Is data available on systemic and/or mucosal immunity?
*
Yes
No
Please indicate assays used:
Is data available on breadth of immune responses across variants?
*
Yes
No
Please indicate assays used:
PRE-CLINICAL QUESTIONS
Is animal data available on systemic and/or mucosal immunity?
*
Yes
No
Which animal model has been used?
Is animal data available on protection?
*
Yes
No
Which animal model has been used?
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3. CMC & Manufacturing
Do you have a (final version) Investigational Medicinal Product Dossier (IMPD) in place?
*
Yes
No
When will it be available?
/
Day
/
Month
Year
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Where is the Drug Substance (DS) manufactured?
*
In Europe
Outside Europe
Not Applicable
Country name
If the DS is manufactured outside Europe, has the manufacturing organization been audited in the last 5 years by a SRA ?
*
Yes
No
If ticked please indicate which SRA performed the audit, the audit date and outcome:
Where is the Drug Product (DP) manufactured?
*
In Europe
Outside Europe
Not Applicable
Country name:
If the DP is manufactured outside Europe, has the manufacturing organization been audited in the last 5 years by a SRA?
*
Yes
No
Please indicate which SRA performed the audit, the audit date and outcome:
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4. Other information
Available publications
Please provide all available publication links.
Do you have freedom to operate?
*
Yes
No
Please provide further information:
Do you own any IP in relation to the vaccine?
*
Yes
No
Optional further information:
Please, indicate the motivation to collaborate with EVH in the development of the vaccine.
*
Max 350 words
Please describe any other information of relevance for this application.
Review Process
EVH consortium partners, and external experts (as needed) will evaluate the proposal. We will not use external experts with an ownership or executive interest in a competitor to the applicant. Please check yes to indicate your agreement to have external reviewers participate in the proposal evaluation.
*
Yes
No
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