Study identification

PURI

https://redirect.ema.europa.eu/resource/25276

EU PAS number

EUPAS15400

Study ID

25276

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 2016/2017 Influenza Season in England

DARWIN EU® study

No

Study countries

United Kingdom

Study description

This is a passive enhanced safety surveillance (ESS) project on the live-attenuated nasal influenza vaccine, Fluenz Tetra®. The aim of the surveillance is to rapidly detect changes in the frequency or severity of reactions to the vaccination in children during the 2016/2017 influenza season. The surveillance is being conducted to satisfy the European Medicines Agency's (EMA) requirement for enhanced safety surveillance for seasonal influenza vaccines in the EU. Children will be 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 are experienced. Any data received will be 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

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
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