Phase 4
N=300
Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2017-2018 Season
Influenza · Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03158038 ↗Enrolled (actual)
300
Serious AEs
0.3%
Results posted
Jan 2019
Primary outcome: Primary: Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F) — 0; 0 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Monovalent Influenza Vaccine (Biological); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F) |
0; 0 | — |
| SECONDARY Percentage of Participants With Solicited Symptoms |
27.9; 26.7; 32.1; 31.7 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
13; 0; 19; 1 | — |
| SECONDARY Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs) |
1; 0; 0; 0; 1; 0 | — |
| SECONDARY Percentage of Participants Who Require Antipyretic and/or Analgesic Medication |
2.1; 1.7; 3.3; 6.7 | — |
Summary
This prospective annual release study is designed to evaluate the safety of 1 new influenza virus vaccine strain to be included in FluMist Quadrivalent for the 2017-2018 influenza season.
Eligibility Criteria
Key Inclusion Criteria
- Age 18 through 49 years
- Written informed consent
- Participant available by telephone
- Ability to understand and comply with the requirements of the protocol, as judged by the Investigator
Key Exclusion Criteria
- Concurrent enrollment in another clinical study up to 180 days after receipt of investigational product (Day 181)
- History of hypersensitivity to any component of the vaccine, including egg or egg protein or serious, life threatening, or severe reactions to previous influenza vaccinations
- Any condition for which the inactivated influenza vaccine is indicated, including chronic disorders of the pulmonary or cardiovascular systems (example [eg], asthma), chronic metabolic diseases (eg, diabetes mellitus), renal dysfunction, or hemoglobinopathies that required regular medical follow-up or hospitalization during the preceding year
- Acute febrile (greater than [>] 100.0 degrees Fahrenheit [F] oral or equivalent) and/or clinically significant respiratory illness (example, cough or sore throat) within 14 days to randomization
- Any known immunosuppressive condition or immune deficiency diseases, including human immunodeficiency virus infection, or ongoing immunosuppressive therapy
- History of Guillain-Barre syndrome
- Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 30 days after the dose of investigational product (use of licensed agents for indications not listed in the Package Insert is permitted)
- Receipt of any non-study vaccine within 30 days prior to randomization, or expected receipt through 30 days after receipt of investigational product
- Expected receipt of antipyretic or analgesic medication on a daily or every other day basis from randomization through 14 days after receipt of investigational product
- Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after administration of investigational product
- Receipt of influenza antiviral therapy or influenza antiviral agents within 48 hours prior to investigational product administration or expected receipt of influenza antiviral therapy or influenza antiviral agents through 14 days after receipt of investigational product
Data sourced from ClinicalTrials.gov (NCT03158038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.