A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated Influenza Vaccine and No Vaccine in Subjects 2-17 Years of Age (ICICLE)

Study identification

• EU PAS number:
  EUPAS10954
• Study ID:
  15275
• Official title and acronym:
  A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated Influenza Vaccine and No Vaccine in Subjects 2-17 Years of Age (ICICLE)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom

  United States
• Study description:
  This is a post-marketing case-controlled study of the effectiveness of a quadrivalent live attenuated influenza vaccine (Q/LAIV/FluMist® Quadrivalent) versus Inactivated Influenza Vaccine (IIV) and No Vaccine in subjects 2-17 years of age.
• Study status:
  Ongoing

Research institutions and networks

Institutions

MedImmune

Study timelines

Date when funding contract was signed

Planned: 02/01/2013

Actual: 02/01/2013

Study start date

Planned: 02/12/2013

Actual: 02/12/2013

Data analysis start date

Planned: 30/04/2014

Actual: 30/04/2014

Date of interim report, if expected

Planned: 30/10/2014

Actual: 30/10/2014

Date of final study report

Planned: 01/11/2017

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)?:
  Non-EU RMP only