This prospective annual release study was designed to assess the safety of a trivalent influenza virus vaccine using two new strains recommended for the 2012-2013 influenza season not previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy adults will receive a single dose of vaccine or placebo and will be followed for 180 days after study vaccination.
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 one dose of investigational product on Study Day 1. The duration of study participation for each subject is the time from study vaccination through 180 days after study vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
303
Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
Placebo is suppllied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
Research Site
Miami, Florida, United States
Research Site
Stockbridge, Georgia, United States
Research Site
Portland, Oregon, United States
Percentage of Participants Reporting Fever Within 7 Days Post Vaccination
A comparison of the rate of fever, defined as oral temperature greater than or equal to 101 degrees Fahrenheit, reported during the 7 days post administration of investigational product between the trivalent influenza virus vaccine and placebo groups.
Time frame: Study Days 1 - 8
Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination
Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.
Time frame: Study Days 1- 8
Percentage of Participants Reporting Any Adverse Event (AE) Within 7 Days Post Vaccination
Percentage of participants reporting at least one AE between Days 1 and 8. Investigational product was administered on Day 1.
Time frame: Study Days 1 - 8
Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination
Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.
Time frame: Study Days 1 - 15
Percentage of Participants Reporting Any Adverse Event (AE) Within 14 Days Post Vaccination
Percentage of participants reporting at least one AE between Days 1 and 15. Investigational product was administered on Day 1.
Time frame: Study Days 1 - 15
Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 28 Days Post Vaccination
Percentage of participants reporting at least one SAE between Days 1 and 29. Investigational product was administered on Day 1.
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Time frame: Study Days 1 - 29
Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 180 Days Post Vaccination
Percentage of participants reporting at least one SAE between Days 1 and 181. Investigational product was administered on Day 1.
Time frame: Study Days 1 - 181
Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination
An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant. Such events were assessed between Day 1 and Day 29. Investigational product was administered on Day 1.
Time frame: Study Days 1 - 29
Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 180 Days Post Vaccination
An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant. Such events were assessed between Day 1 and Day 181. Investigational product was administered on Day 1.
Time frame: Study Days 1 - 181
Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 7 Days Post Vaccination
Percentage of participants who used an antipyretic or analgesic agent between Days 1 and 8. Investigational product administration occurred on Day 1.
Time frame: Study Days 1 - 8
Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 14 Days Post Vaccination
Percentage of participants who used an antipyretic or analgesic agent between Days 1 and 15. Investigational product administration occurred on Day 1.
Time frame: Study Days 1 - 15