Postmarketing Safety Study of Q/LAIV in Subjects 2 Through 49 Years of Age

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/15446
• EU PAS number:
  EUPAS4848
• Study ID:
  15446
• Official title and acronym:
  Postmarketing Safety Study of Q/LAIV in Subjects 2 Through 49 Years of Age
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Children and adults will be immunized with Q/LAIV as part of routine clinical practice at Kaiser Permanente Northern California (NCKP) sites. Using existing data on healthcare utilization, rates of medically attended events (MAEs) of interest will be evaluated in all eligible Q/LAIV recipients who are vaccinated in the Kaiser Permanente (KP) Northern California Health Care Plan during the 2013-2014 influenza season. Enrollment must include a minimum of 10,000 children 2 through 8 years of age, based on previous utilization of FluMist at NCKP, enrollment is expected to include approximately 80,000 children and adults 2 to 49 years of age.Similar to previous postmarketing safety studies conducted with trivalent LAIV, this study will be conducted using data collected by the KP Vaccine Study Center. Incidence rates of MAEs and hospitalizations during periods at risk after Q/LAIV vaccination will be compared versus incidence rates during reference periods later in the follow-up (within-cohort analysis) and versus rates in 2 nonrandomized control groups: matched unvaccinated controls and matched concurrent inactivated influenza vaccine (IIV) recipient controls identified from the KP healthcare database. Trivalent inactivated vaccine (TIV) recipients will serve as controls along with quadrivalent inactivated influenza vaccine (QIIV) recipients if a QIIV is approved and administered during the study period.
• Study status:
  Finalised

Research institution and networks

Institutions

Kaiser Permanente Southern California (KPSC)

Study timelines

Date when funding contract was signed

Planned: 18/10/2013

Actual: 18/10/2013

Study start date

Planned: 18/10/2013

Actual: 18/10/2013

Data analysis start date

Planned: 15/04/2015

Actual: 15/04/2014

Date of interim report, if expected

Planned: 30/11/2014

Actual: 21/11/2014

Date of final study report

Planned: 30/06/2018

Actual: 09/08/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

MedImmune

Study protocol

Initial protocol

pass-protocol-ma-va-medi3250-1115

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only