A Post Marking Study to Evaluate the Safety of FluMist in Children

A Post Marketing Evaluation of the Safety of FluMist in Children 24-59 Months of Age in a Managed Care Setting

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00569894

Enrollment

29296

Registered

2007-12-10

Start date

2007-10-31

Completion date

2011-06-30

Last updated

2012-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

To assess the safety of FluMist vaccination

Detailed description

* To assess the safety of FluMist vaccination Rates of medically attended events in FluMist recipients, including serious adverse events (SAEs), anaphylaxis , urticaria, asthma, wheezing, pre-specified grouped diagnoses, and rare events potentially related to wild-type influenza, will be compared to rates in multiple non-randomized control groups. * To assess the safety of annual FluMist re-vaccination \[Rates of MAEs in the subset of children who receive FluMist in ≥2 consecutive years will be compared to rates in first-time vaccinees during the same season.\] * To assess the safety of FluMist vaccination in children previously vaccinated with trivalent inactivated influenza vaccine (TIV) \[Rates of MAEs in the subset of children who received one or more prior TIV vaccinations will be compared to rates in children who did not receive prior TIV.\]

Interventions

BIOLOGICALFLuMist

One or two vaccinations with FluMist depending on prior vaccination status.

BIOLOGICALTIV (Injection)

One or two injections of TIV depending on previous status.

OTHERUnvaccinated Control

no vaccine

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

24 Months to 59 Months

Healthy volunteers

Yes

Inclusion criteria

* Healthy * Age: born within the same calendar quarter as the reference FluMist vaccinee.

Exclusion criteria

* Children who have evidence of medical conditions that put them at high risk for complications of influenza (e.g., chronic cardiovascular and pulmonary disease) will be excluded from this control group.

Design outcomes

Primary

Measure	Time frame
Assess Medically Attended Events(MAEs)of anaphylaxis,urticaria, asthma,wheezing,pre-specified grouped diagnoses,and rare events related to wild-type influenza,MAEs-qualify as SAEs,in:emergency department,clinic,and hospital setting.	1, 3, 21, or 42 days post dose; 6 months post dose; entire study period)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026