Prospective non-interventional cohort study to assess safety and tolerability of Fluval AB 2014/2015 trivalent seasonal influenza vaccine in children, adolescents, adults and elderly subjects (FluvalAB-H-17)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/15266
• EU PAS number:
  EUPAS7842
• Study ID:
  15266
• Official title and acronym:
  Prospective non-interventional cohort study to assess safety and tolerability of Fluval AB 2014/2015 trivalent seasonal influenza vaccine in children, adolescents, adults and elderly subjects (FluvalAB-H-17)
• DARWIN EU® study:
  No
• Study countries:
  Hungary
• Study description:
  The aim of this observational study, is to detect a potential increase in reactogenicity and allergic events that is intrinsic to the product in near real-time as part of the active surveillance of subjects vaccinated with Fluval AB vaccine containing influenza virus strains recommended for the 2014/2015 seasonal epidemics in accordance with the Summary of Product Characteristics. Objective:The objective of the study is to evaluate the occurrence of adverse events (AEs) in vaccinated subjects participating in the study and to rapidly detect any clinically significant change (compared to what was known or expected with the previous vaccine composition) in the frequency and severity of AEIs in vaccinated subjects participating in the study that may indicate a potential for more serious risks as exposure to the vaccine increases.Defined cohorts of children and adults will be actively followed-up seven (7) days after immunisation for AEs following vaccination, with the aim to detect eventual changes (compared to the safety profile defined in the Summary of Product Characteristics) in the frequency and severity of defined AEIs. Six hundred (600) subjects will be vaccinated with Fluval AB vaccine containing influenza virus strains recommended for the 2014/2015 seasonal epidemics in accordance with the Summary of Product Characteristics and participate in the study, evaluated in order to achieve at least five hundred (500) evaluable subjects giving at least one hundred (100) male and female vaccinated subjects in each defined age groups (3-5, 6-12, 13-17, 18-65 years and over 65 years), according to Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU EMA/PRAC/222346/2014.
• Study status:
  Finalised

Research institutions and networks

Institutions

Országos Epidemiológiai Központ

OEK Ifluenza Laboratórium, H-1097 Budapest, Albert Flórián út 2-6, RE-GULYA Kft., H-1037 Budapest, Erdőalja u. 2, N/A, h-4813 Gyüre, Árpád út 26, Pedia-mix Egészségügyi, Oktatási és Szolgáltató Kft., H-1188 Budapest, Póth Irén u. 80, Mother and Son Bt., H-1097 Budapest, Albert Flórián út 5-7. 1. ép.– B old, ELITANCE Bt., H-1188 Budapest, Póth Irén u. 80, N/A, H-1184 Budapest, Dolgozó u. 12, N/A, H-2339 Majosháza, Árpád u. 30, Bonyhády Egészségügyi Kft., H-2133 Sződliget, Orgona u. 11, MOMED Bt., H-2093 Budajenő, József A. u. 2

Study timelines

Date when funding contract was signed

Actual: 31/10/2014

Study start date

Planned: 01/12/2014

Actual: 09/12/2014

Data analysis start date

Planned: 08/12/2014

Actual: 16/12/2014

Date of interim report, if expected

Planned: 01/01/2015

Actual: 09/01/2015

Date of final study report

Planned: 01/05/2015

Actual: 27/05/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Fluart Innovative Vaccines Ltd

Study protocol

Initial protocol

FluvalAB-H-17 Vizsgálati terv_20141029

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)