Postmarketing Safety Study of Q/LAIV in Subjects 2 Through 49 Years of Age
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ClinicalTrials.gov Identifier: NCT01985997 |
Recruitment Status
:
Completed
First Posted
: November 18, 2013
Last Update Posted
: September 7, 2016
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Condition or disease |
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Observation Safety |
Study Type : | Observational |
Actual Enrollment : | 95000 participants |
Time Perspective: | Prospective |
Official Title: | Postmarketing Safety Study of Q/LAIV in Subjects 2 Through 49 Years of Age |
Study Start Date : | January 2014 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | July 2014 |
- 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

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- . 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.
Exclusion Criteria:

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985997
United States, California | |
Research Site | |
Oakland, California, United States |
Study Director: | Herve Caspard, MD | MedImmune LLC |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT01985997 History of Changes |
Other Study ID Numbers: |
MA-VA-MEDI3250-1115 |
First Posted: | November 18, 2013 Key Record Dates |
Last Update Posted: | September 7, 2016 |
Last Verified: | September 2016 |
Keywords provided by MedImmune LLC:
FluMist, Quadrivalent, Vaccine |