Study identification

EU PAS number

EUPAS15277

Study ID

28395

Official title and acronym

Passive Enhanced Safety Surveillance (ESS) of Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) Fluenz Tetra in Children and Adolescents during the early 2015/2016 Influenza Season in England

DARWIN EU® study

No

Study countries

United Kingdom

Study description

This was a passive enhanced safety surveillance (ESS) project on the live-attenuated nasal influenza vaccine, Fluenz Tetra®. The aim of the surveillance was to rapidly detect changes in the frequency or severity of reactions to the vaccination in children during the 2015/2016 influenza season. The surveillance was conducted to satisfy the European Medicines Agency's (EMA) requirement for enhanced safety surveillance for seasonal influenza vaccines in the EU. Children were provided with a Safety Report Card with an integrated consent form following vaccination for completion by their parents in the event that any suspected side effects were experienced. Any data received was collated and analysed and a report submitted to the EMA.

Study status

Finalised
Research institutions and networks

Institutions

Networks

Contact details

Saad Shakir

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

AstraZeneca
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable