Phase 4
N=301
Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2016-2017 Season
Influenza · Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02743117 ↗Enrolled (actual)
301
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F) — 1.7; 0.4 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
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F) |
1.7; 0.4 | — |
| SECONDARY Percentage of Participants With Solicited Symptoms |
33.9; 25.7; 37.3; 29.9 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
1; 9; 1; 14 | — |
| SECONDARY Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Who Require Antipyretic and/or Analgesic Medication |
3.4; 1.2; 5.1; 1.7 | — |
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 2016-2017 influenza season
Eligibility Criteria
Inclusion Criteria
- Age 18 through 49 years
- Written informed consent
- Subject available by telephone
- Ability to understand and comply with the requirements of the protocol, as judged by the Investigator
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 prior to randomization
- Any known immunosuppressive condition or immune deficiency disease, including human immunodeficiency virus infection, or ongoing immunosuppressive therapy
- History of Guillain-Barré syndrome
Data sourced from ClinicalTrials.gov (NCT02743117). 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.