Status: Ongoing First registered on: 11/10/2018
Last updated on: 29/07/2019
1. Study identification
EU PAS Register NumberEUPAS25599
Official titleCase-control study based on hospitals about seasonal influenza vaccine effectiveness to avoid income associated with laboratory-confirmed influenza virus infection in subjects aged 18 or more during 2011-2020 seasons and the disease burden due to respiratory viruses in patients of any age admitted into the hospitals included in the study (AIV - Fisabio)
Study title acronymHBTNCC
Study typeObservational study
Brief description of the studyInfluenza and vaccination against influenza have a profound impact on society. Thus, knowing the illness burden due to influenza and the impact of current vaccination programs is necessary to take present and future decisions. On the other hand, given the characteristics of the virus and the vaccine, this information must be generated in a timely and continuous manner, so it is convenient to study several flu seasons in large samples of the population. For this purpose, estimates of the influenza vaccine effectiveness based on information from sentinel medical networks using case-control studies or screening methods are useful.These estimates must be timely, robust and reliable, so that the parts involved can take decisions and assessing the impact of the measures adopted have useful information and quality. This need justifies the performance of phase IV post-authorization effectiveness studies based on the impact of the infection and preventive measures on hospital admissions due to influenza. In our case, it is a case-control study based on a hospital-based system of active surveillance of incident income where the presence of influenza infection is verified with the study's own resources. The methodology of detection of virus infection also allows carrying out a study of the burden of the disease by detecting the incidental income associated with respiratory viruses.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameFISABIO
Centre locationValencia
Details of (Primary) lead investigator
Title Dr
Last name Díez-Domingo
First name Javier
Is this study being carried out with the collaboration of a research network?
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?4
Hospital General, Alicante
Hospital General, Castellón
Hospital La Fe, Valencia
Hospital Doctor Peset, Valencia
Countries in which this study is being conducted
National study

3. Study timelines: initial administrative steps, progress reports and final report
Date when funding contract was signed03/09/201803/09/2018
Start date of data collection10/09/201810/09/2018
Start date of data analysis
Date of interim report, if expected
Date of final study report31/10/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesSanofi Pasteur S.A.70
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Miss
Last name Mira-Iglesias
First name Ainara
Address line 1Av. Cataluña, 21
Address line 2 
Address line 3 
Phone number (incl. country code)0034961925700 
Alternative phone number 
Fax number (incl. country code) 
Email address
Public Enquiries
Title Mr 
Last name Garcia-Rubio 
First name Javier 
Address line 1Av. Cataluña, 21 
Address line 2 
Address line 3 
Phone number (incl. country code)0034961925700 
Alternative phone number 
Fax number (incl. country code) 
Email address