Phase 4 N=300 Randomized Quadruple-blind Prevention

Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults for the 2015-2016 Season

Influenza · Healthy

Bottom Line

View on ClinicalTrials.gov: NCT02473510 ↗

Enrolled (actual)

300

Serious AEs

0.3%

Results posted

Nov 2016

Primary outcome: Primary: Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F) — 0; 0.4 Percentage of Participant

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: Jan 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)	0; 0.4	—
SECONDARY Percentage of Participants With Solicited Symptoms	20.0; 36.7; 21.7; 39.6	—
SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs)	3; 13; 3; 14	—
SECONDARY Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Disease (NOCDs)	0; 0; 0; 0; 0; 1	—
SECONDARY Percentage of Participants Who Require Antipyretic and/or Analgesic Medication	0; 0.4; 0; 0.8	—

Summary

This prospective annual release study is designed to evaluate the safety of 3 new influenza virus vaccine strains to be included in FluMist Quadrivalent for the 2015-2016 influenza season

Eligibility Criteria

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02473510). 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.