Clinical trial NCT01859143: Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Healthy
Keywords: Trivalent
Influenza
FluMist Quadrivalent
Vaccine
Prevention
Healthy
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2013-05-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: This prospective, randomized, double-blind, placebo-controlled release study will enroll approximately 300 healthy adults 18 to 49 years of age. Eligible subjects will be randomly assigned in a 4:1 fashion to receive a single dose of trivalent vaccine or placebo by intranasal spray. Randomization will be stratified by site. This study will be conducted at 3 sites in the United States of America. Each subject will receive 1 dose of investigational product on Day 1. The duration of study participation for each subject is the time from study vaccination through 180 days after study vaccination.

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

Primary outcomes:
measure: Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)
timeFrame: Within 7 days after vaccination
Secondary outcomes:
measure: Percentage of Participants With Solicited Symptoms
timeFrame: Within 7 and 14 days after vaccination
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Within 7 and 14 days after vaccination
measure: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs)
timeFrame: Within 28 and 180 days after vaccination
measure: Percentage of Participants Who Required Antipyretic and/or Analgesic Medication
timeFrame: Within 7 and 14 days after vaccination
Other outcomes:
Locations:
city: Miami
country: United States
facility: Research Site
state: Florida
city: Stockbridge
country: United States
facility: Research Site
state: Georgia
city: Portland
country: United States
facility: Research Site
state: Oregon
Study officials:
affiliation: MedImmune LLC
name: Raburn Mallory, MD
role: STUDY_DIRECTOR
References: