Phase 4
Completed N=300
D2560C00015 FluMist Annual Safety Study 2018
Influenza · Healthy
Source: ClinicalTrials.gov NCT03564444 ↗
Enrolled (actual)
300
Serious AEs
0.3%
Results posted
Dec 2019
Primary outcomePrimary: Percentage of Participants Reporting Fever (Oral Temperature >= 101 Degrees Fahrenheit) Through Day 8 — 0; 0 Percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This prospective annual release study is designed to evaluate the safety of 2 new influenza virus vaccine strains to be included in FluMist Quadrivalent for the 2018-2019 influenza season.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Reporting Fever (Oral Temperature >= 101 Degrees Fahrenheit) Through Day 8 |
0; 0 | — |
| SECONDARY Number of Participants With Solicited Symptoms Through Day 8 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Solicited Symptoms Through Day 15 |
0; 1; 0; 1; 0; 1 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) Through Day 8 and Day 15 |
1; 15; 2; 19 | — |
| SECONDARY Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Through Day 29 and Day 181 |
0; 1; 0; 1 | — |
| SECONDARY Number of Participants With New Onset Chronic Diseases (NOCDs) Through Day 29 and Day 181 |
0; 0; 0; 0 | — |
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), renaldysfunction, 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.
Data sourced from ClinicalTrials.gov (NCT03564444). 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. Informational only — not medical advice.