Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Influenza
• Intervention / Treatment: Other: Placebo; Biological: Trivalent Influenza Vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States
      • Research Site
  • Georgia
    • Stockbridge, Georgia, United States
      • Research Site
  • Oregon
    • Portland, Oregon, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; A single dose of placebo matched to trivalent influenza vaccine will be administered as intranasal spray on Day 1.	Other: Placebo; A single dose of placebo matched to trivalent influenza vaccine will be administered as intranasal spray on Day 1.
Experimental: Trivalent Influenza Vaccine; A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine will be administered as intranasal spray on Day 1.	Biological: Trivalent Influenza Vaccine; A single dose of 10^(7.0 ± 0.5) FFU of trivalent influenza vaccine will be administered as intranasal spray on Day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)	Percentage of participants with fever defined as oral temperature >=101 degrees F were reported.	Within 7 days after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Solicited Symptoms	Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily after vaccine administration up to 14 days after vaccination. The solicited symptoms included fever greater than (>) 100.0 degrees F (37.8 degrees Celsius), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity and headache. Results are reported for all solicited symptoms except fever >=101 degrees F (reported as primary outcome) within 7 days after vaccination and all solicited symptoms within 14 days after vaccination.	Within 7 and 14 days after vaccination
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were events between administration of study drug and up to 14 days after vaccination that were absent before treatment or that worsened relative to pre-treatment state. Results are given for AEs reported within 7 days and 14 days after vaccination.	Within 7 and 14 days after vaccination
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent SAEs were serious events between administration of study drug and up to 180 days after the dose that were absent before treatment or that worsen relative to pretreatment state. An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Results are given for TESAEs and NOCDs reported within 28 days and 180 days after vaccination.	Within 28 and 180 days after vaccination
Percentage of Participants Who Required Antipyretic and/or Analgesic Medication		Within 7 and 14 days after vaccination

Collaborators and Investigators

• Sponsor: MedImmune LLC
• Collaborators: AstraZeneca

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: May 17, 2013
• First Submitted That Met QC Criteria: May 20, 2013
• First Posted (Estimate): May 21, 2013

Study Record Updates

• Last Update Posted (Estimate): November 10, 2014
• Last Update Submitted That Met QC Criteria: November 7, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Influenza; Vaccine; Healthy; Prevention; Trivalent; FluMist Quadrivalent
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: MED-VA-FLUMIST-1156