HealthyNCT00569894

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

An observational study of Healthy, run by MedImmune LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To assess the safety of FluMist vaccination Read more about this study

Who is it for?: Ages 24 to 59 monthsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: FLuMist and TIV (Injection)
Type of treatment: Vaccines, Injection or infusion
How many people: 29,296 participants
Where: 1 siteUnited States
Study dates: Oct 2007to Jun 2011
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 24 to 59 months
All sexes
Healthy volunteers accepted
Child

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.

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Research Site
Oakland, California

Other trials in United States

About this study

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

To assess the safety of FluMist vaccination

Read the 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.]

Conditions: Healthy
Being tested: FLuMist, TIV (Injection), Unvaccinated Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FLuMistBiological
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 ControlOther
no vaccine

Study groups in NCT00569894
Study group	Role	What they receive
2		TIV Receives: Biological: TIV (Injection)
1		FluMist Receives: Biological: FLuMist
3		Unvaccinated Receives: Other: Unvaccinated Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Jun 2011

First posted10 Dec 2007 (estimated)
Study startOct 2007
Primary completionJun 2011
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 29,296 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00569894
Sponsor's protocol ID: MI-MA162
Status last verified: Mar 2012
First submitted: 6 Dec 2007
Last updated: 8 Mar 2012
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
Healthy

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post Marketing Evaluation of the Safety of FluMist in Children 24-59 Months of Age in a Managed Care Setting
ClinicalTrials.gov ID: NCT00569894
Acronym / sponsor ID: MI-MA162
Conditions: Healthy
Study type: Observational
Recruitment status: Completed
Enrolment: 29,296 participants (actual)
Lead sponsor: MedImmune LLCIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 10 Dec 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.]

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
2	–	Biological: TIV (Injection)TIV
1	–	Biological: FLuMistFluMist
3	–	Other: Unvaccinated ControlUnvaccinated

Who may qualify

Ages: 24 to 59 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child
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.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FLuMistOne or two vaccinations with FluMist depending on prior vaccination status.	Biological	1
TIV (Injection)One or two injections of TIV depending on previous status.	Biological	2
Unvaccinated Controlno vaccine	Other	3

Primary outcome

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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.

Related trials for Healthy

Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
Healthy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Seth Toback, M.D. study director

MedImmune LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by MedImmune LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00569894.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2012.