Observation SafetyNCT01985997
Postmarketing Safety Study of Q/LAIV in Subjects 2 Through 49 Years of Age
An observational study of Observation Safety, run by MedImmune LLC at 1 site in United States.
Trial summary
This is an observational post-marketing study conducted in children and adults immunized with Q/LAIV as part of routine clinical practice at Kaiser Permanente Northern California (NCKP) sites. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Observation Safety
- How many people
- 95,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jul 2014
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Children and adults 2 to 49 years of age vaccinated with Q/LAIV, TIV or no vaccine at Kaiser Permenente Northern California sites.
Who may be able to join
- . Age 2 through 49 years at the time of vaccination (or index date for unvaccinated controls)
- . Membership in the KP Health Care Plan for at least 12 months prior to vaccination/index date
- . Continuous enrollment in KP Health Care Plan through 6 months following vaccination/index date.
Who cannot join
- NONE
Trial locations and contacts
1 site in 1 country.
About this study
This is an observational post-marketing study conducted in children and adults immunized with Q/LAIV as part of routine clinical practice at Kaiser Permanente Northern California (NCKP) sites.
Read the detailed description
Children and adults will be immunized with Q/LAIV as part of routine clinical practice at Kaiser Permanente Northern California (NCKP) sites. Using existing data on healthcare utilization, rates of medically attended events (MAEs) of interest will be evaluated in all eligible Q/LAIV recipients who are vaccinated in the Kaiser Permanente (KP) Northern California Health Care Plan during the 2013-2014 influenza season. Enrollment must include a minimum of 10,000 children 2 through 8 years of age; based on previous utilization of FluMist at NCKP, enrollment is expected to include approximately 80,000 children and adults 2 to 49 years of age.
- Conditions
- Observation Safety
- Keywords
- FluMist, Quadrivalent, Vaccine
- Medical subject headings
- Influenza, Human
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of medically attended events: hypersensitivity, seizures/convulsions
Rates of medically attended events from 0 to 3 days: hypersensitivity, seizures/convulsions
Measured: From 0-3 days
Rates of medically attended events: lower respiratory tract infection, wheezing, Guillain-Barré syndrome, Bell's palsy, encephalitis, neuritis, vasculitis, any hospitalization and respiratory hospitalizations
Rates of medically attended events from 1 to 42 days: lower respiratory tract infection, wheezing, Guillain-Barré syndrome, Bell's palsy, encephalitis, neuritis, vasculitis, any hospitalization and respiratory hospitalizations
Measured: From 1 to 42 days
Rates of medically attended events: narcolepsy/cataplexy
Rates of medically attended events from 1 to 180 days: narcolepsy/cataplexy
Measured: From 1 to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Observation SafetyStudies 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
- Time perspective
- Prospective
- Enrolment
- 95,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herve Caspard, MD, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985997
- Sponsor's protocol ID
- MA-VA-MEDI3250-1115
- Status last verified
- Sep 2016
- First submitted
- 11 Nov 2013
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Baxter R, Eaton A, Hansen J, Aukes L, Caspard H, Ambrose CS. Safety of quadrivalent live attenuated influenza vaccine in subjects aged 2-49years. Vaccine. 2017 Mar 1;35(9):1254-1258. doi: 10.1016/j.vaccine.2017.01.062. Epub 2017 Feb 2.
PubMed 28162825
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postmarketing Safety Study of Q/LAIV in Subjects 2 Through 49 Years of Age
- ClinicalTrials.gov ID
- NCT01985997
- Acronym / sponsor ID
- MA-VA-MEDI3250-1115
- Conditions
- Observation Safety
- Keywords
- FluMist, Quadrivalent, Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95,000 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 18 Nov 2013 (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.
This is an observational post-marketing study conducted in children and adults immunized with Q/LAIV as part of routine clinical practice at Kaiser Permanente Northern California (NCKP) sites.
Detailed description
Children and adults will be immunized with Q/LAIV as part of routine clinical practice at Kaiser Permanente Northern California (NCKP) sites. Using existing data on healthcare utilization, rates of medically attended events (MAEs) of interest will be evaluated in all eligible Q/LAIV recipients who are vaccinated in the Kaiser Permanente (KP) Northern California Health Care Plan during the 2013-2014 influenza season. Enrollment must include a minimum of 10,000 children 2 through 8 years of age; based on previous utilization of FluMist at NCKP, enrollment is expected to include approximately 80,000 children and adults 2 to 49 years of age.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children and adults 2 to 49 years of age vaccinated with Q/LAIV, TIV or no vaccine at Kaiser Permenente Northern California sites.
Key inclusion criteria (3 listed)
- . Age 2 through 49 years at the time of vaccination (or index date for unvaccinated controls)
- . Membership in the KP Health Care Plan for at least 12 months prior to vaccination/index date
- . Continuous enrollment in KP Health Care Plan through 6 months following vaccination/index date.
Key exclusion criteria (1 listed)
- NONE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rates of medically attended events: hypersensitivity, seizures/convulsions
Time frame: From 0-3 days
Rates of medically attended events from 0 to 3 days: hypersensitivity, seizures/convulsions
Rates of medically attended events: lower respiratory tract infection, wheezing, Guillain-Barré syndrome, Bell's palsy, encephalitis, neuritis, vasculitis, any hospitalization and respiratory hospitalizations
Time frame: From 1 to 42 days
Rates of medically attended events from 1 to 42 days: lower respiratory tract infection, wheezing, Guillain-Barré syndrome, Bell's palsy, encephalitis, neuritis, vasculitis, any hospitalization and respiratory hospitalizations
Rates of medically attended events: narcolepsy/cataplexy
Time frame: From 1 to 180 days
Rates of medically attended events from 1 to 180 days: narcolepsy/cataplexy
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 7 Sep 2016.
- Derived from this study: PubMed 28162825Baxter R, Eaton A, Hansen J, Aukes L, Caspard H, Ambrose CS. Safety of quadrivalent live attenuated influenza vaccine in subjects aged 2-49years. Vaccine. 2017 Mar 1;35(9):1254-1258. doi: 10.1016/j.vaccine.2017.01.062. Epub 2017 Feb 2.
- MA-VA-MEDI3250-1115 Redacted CSR SynopsisLink provided by the sponsor.
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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.
Herve Caspard, MD 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 Observation Safety, 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 3 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 7 Sep 2016. 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?
Rates of medically attended events: hypersensitivity, seizures/convulsions (time frame: From 0-3 days). The study lists 3 primary outcomes in all. 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 NCT01985997, which also lists 1 linked publication.
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 7 Sep 2016.