A Postmarketing Noninterventional Cohort Study of the Safety of Live Attenuated Influenza Vaccine (LAIV) in Subjects 2 Through 17 Years of Age (Flu vaccine feedback study)

Study identification

• EU PAS number:
  EUPAS7626
• Study ID:
  15337
• Official title and acronym:
  A Postmarketing Noninterventional Cohort Study of the Safety of Live Attenuated Influenza Vaccine (LAIV) in Subjects 2 Through 17 Years of Age (Flu vaccine feedback study)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Following the introduction of the interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU, the DSRU is conducting a post authorisation safety (PASS) non-interventional cohort study to determine the incidence of adverse events of interest (AEI) following vaccination with the nasal LAIV, Fluenz Tetra® in the authorised age range (children 2-17 years of age) during the 2014/2015 influenza season. The aim of the study is to rapidly detect a clinically significant change (compared to what was known or expected of the previous year’s influenza vaccine) in the frequency and/or severity of expected reactogenicity (local, systemic, or allergic reactions) after administration of nasal LAIV, Fluenz Tetra® in children 2 to 17 years of age that may indicate a potential for more serious risks as the frequency of exposure to the vaccine increases. Vaccinees will be recruited via the mass vaccination programme through GP practices and through the pilot schools vaccination programme. Patient outcomes, validated by GPs where appropriate, will be captured through questionnaires (received via surface mail or the study website) and coded onto the DSRU database. Patients or their guardians will be asked to complete a questionnaire at enrolment and another 14 days after vaccination. Approximately 200 vaccinees consented per age group: (i) 2 years to <5 years (ii) 5 to <11 years (iii) 11 to 17 years, will be recruited although enrolment will continue to ensure the target of a minimum of 100 vaccinees with completed data per age group is reached.
• Study status:
  Finalised

Research institutions and networks

Institutions

Drug Safety Research Unit (DSRU)

United Kingdom

Networks

NIHR Medicines for Children Research Network

Study timelines

Date when funding contract was signed

Planned:28/07/2014

Actual:28/07/2014

Study start date

Planned:03/10/2014

Actual:03/10/2014

Date of final study report

Planned:27/02/2015

Actual:18/03/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

MedImmune

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable