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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29296 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-06-30

Brief Summary

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To assess the safety of FluMist vaccination

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Detailed Description

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* 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) \[Rates of MAEs in the subset of children who received one or more prior TIV vaccinations will be compared to rates in children who did not receive prior TIV.\]

Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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2

TIV

TIV (Injection)

Intervention Type BIOLOGICAL

One or two injections of TIV depending on previous status.

1

FluMist

FLuMist

Intervention Type BIOLOGICAL

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

3

Unvaccinated

Unvaccinated Control

Intervention Type OTHER

no vaccine

Interventions

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FLuMist

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

Intervention Type BIOLOGICAL

TIV (Injection)

One or two injections of TIV depending on previous status.

Intervention Type BIOLOGICAL

Unvaccinated Control

no vaccine

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

24 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes