Phase 4
N=300
Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults
Influenza · Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01859143 ↗Enrolled (actual)
300
Serious AEs
1.0%
Results posted
Nov 2014
Primary outcome: Primary: Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F) — 0.4; 0.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Trivalent Influenza Vaccine (Biological); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F) |
0.4; 0.0 | — |
| SECONDARY Percentage of Participants With Solicited Symptoms |
37.3; 25.4; 0.8; 0.0; 0.0; 0.0 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
26; 4; 28; 5 | — |
| SECONDARY Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs) |
1; 0; 1; 2; 0; 0 | — |
| SECONDARY Percentage of Participants Who Required Antipyretic and/or Analgesic Medication |
9.1; 5.1; 8.7; 5.1; 9.1; 6.8 | — |
Summary
This prospective annual release study is designed to evaluate the safety on new influenza virus vaccine strains to be included in FluMist Quadrivalent for the 2013-2014 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 (NCT01859143). 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.