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OpenTrials
Completed

NCT Number: NCT00569894

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

To assess the safety of FluMist vaccination

Completed

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Key information

Conditions

Healthy

Age range

24 month–59 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Oakland, California, United States

About this study

  • 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.]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FluMist

Biological

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

TIV (Injection)

Biological

One or two injections of TIV depending on previous status.

Unvaccinated Control

Other

no vaccine

Primary outcomes

  1. 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.

    Time frame: 1, 3, 21, or 42 days post dose; 6 months post dose; entire study period)

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Dec 10, 2007
Registry last updated
Mar 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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