Prospective non-interventional cohort study to assess safety and tolerability of 3Fluart 2018/2019 trivalent seasonal influenza vaccine in children, adolescents, adults and elderly subjects (3Fluart-H-22)

Study identification

• EU PAS number:
  EUPAS24284
• Study ID:
  29506
• Official title and acronym:
  Prospective non-interventional cohort study to assess safety and tolerability of 3Fluart 2018/2019 trivalent seasonal influenza vaccine in children, adolescents, adults and elderly subjects (3Fluart-H-22)
• DARWIN EU® study:
  No
• Study countries:
  Hungary
• Study description:
  The aim of this observational study, which will be initiated right after 3Fluart 2018/2019 seasonal influenza vaccine is licensed and used in a mass vaccination campaign, is to detect a potential increase in reactogenicity and allergic events that is intrinsic to the product in near real-time aiming to mitigate risks before the peak period of seasonal immunisation. The objectives are to evaluate the occurrence of defined Adverse Events of Interests (AEIs) and other 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 compositions in the frequency and severity of Adverse Reactions (ARs) in vaccinated subjects participating in the study. Defined cohorts of children and adults will be actively followed-up seven (7) days after immunisation for AEIs and other AEs following vaccination, with the aim to detect eventual changes in the frequency and severity of related events. Patients will be vaccinated according to the Summary of Product Characteristics (SmPC), in compliance with national vaccination policy decisions in Hungary and standard practice, then, will be involved into the study by signing the patient information and informed consent and forms. Relevant information on AEs will be collected during a follow-up phone contact seven (7) days after vaccination. The duration of the study on a patient basis will be seven (7) days. The study will be conducted in multiple study centres in Hungary. A maximum of six hundred (600) and a minimum of five hundred (500) male and female subjects will be vaccinated with 3Fluart vaccine containing influenza virus strains recommended for the 2018/2019 seasonal epidemics in accordance with the SmPC and involved into the study according to Interim guidence on enhanced safety surveillance for seasonal influenza vaccines in the EU.
• Study status:
  Finalised

Research institutions and networks

Institutions

Gyermek Háziorvosi Rendelő

Multiple centres: 12 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:30/05/2018

Actual:31/05/2018

Study start date

Planned:01/10/2018

Actual:15/10/2018

Data analysis start date

Planned:08/10/2018

Actual:22/10/2018

Date of interim report, if expected

Planned:01/11/2018

Actual:15/11/2018

Date of final study report

Planned:01/06/2019

Actual:05/04/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Fluart Innovative Vaccines Ltd.

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)