A Study to Evaluate the Safety of FluMist in Healthy Children and Healthy Adults

MedImmune

Status: Completed

Conditions: Healthy

Treatments: Biological: FluMist

Study type: Observational

Funder types: Industry

Identifiers

NCT00113880

FM025

Details and patient eligibility

About

The purpose of this study was to expand the data describing the safety profile of FluMist in the indicated populations (5-8, 9-17, and 18-49 years of age) and to assess the safety of annual revaccination in those who received FluMist in 2 or more consecutive years.

Full description

The primary objective of this study was to assess the safety of FluMist vaccination by comparing the rates of medically attended events (MAEs) (including serious adverse events [SAEs], anaphylaxis, urticaria, asthma, wheezing, pre-specified grouped diagnoses, and rare events potentially related to wild-type influenza) in FluMist recipients to rates in multiple non-randomized control groups.

Enrollment: 63,061 patients

Sex: All

Ages: 5 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 5-49 years of age
• Members of the Kaiser Permanente (KP) Health Care Plan within KP of Northern California, KP of Colorado, and KP of Hawaii

Exclusion criteria

• Must not have had any high risk underlying medical conditions, includig asthma

Trial design

63,061 participants in 3 patient groups

1

Description:

5-8 years of age, estimated to be approximately 4,000 new FluMist vaccinees per season

Treatment:

Biological: FluMist

Biological: FluMist

Biological: FluMist

2

Description:

9-17 years of age, estimated to be approximately 5,000 new FluMist vaccinees per season

Treatment:

Biological: FluMist

Biological: FluMist

Biological: FluMist

3

Description:

18-49 years of age, estimated to be approximately 6,000 new FluMist vaccinees per season.

Treatment:

Biological: FluMist

Biological: FluMist

Biological: FluMist