NCT00569894

Brief Summary

To assess the safety of FluMist vaccination

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29,296

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 10, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

Enrollment Period

3.7 years

First QC Date

December 6, 2007

Last Update Submit

March 6, 2012

Conditions

Healthy

Outcome Measures

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.

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

Study Arms (3)

2

TIV

Biological: TIV (Injection)

1

FluMist

Biological: FLuMist

3

Unvaccinated

Other: Unvaccinated Control

Interventions

FLuMistBIOLOGICAL

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

1
TIV (Injection)BIOLOGICAL

One or two injections of TIV depending on previous status.

2
Unvaccinated ControlOTHER

no vaccine

3

Eligibility Criteria

Age24 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The populations to be assessed are FluMist recipients, TIV recipient controls, and unvaccinated controls. Members of the Kaiser Permanente Health Care Plan may be included in this study as part of routine care at their participating health centers within the Kaiser Permanente health maintenance organization (HMO) of Northern California.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Oakland, California, United States

Location

MeSH Terms

Interventions

FluMistInjections

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Seth Toback, M.D.

    MedImmune LLC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 6, 2007

First Posted

December 10, 2007

Study Start

October 1, 2007

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations

US(1)