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

Healthy Clinical Trial

— FluMist  

Official title:

A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02473510
• Other study ID #: D2560C00009
• Status: Completed
• Phase: Phase 4
• First received: June 12, 2015
• Last updated: March 8, 2016
• Start date: June 2015
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy
• Influenza
• Influenza, Human

Intervention

Biological:
• Trivalent Influenza Vaccine
A single dose of 10^(7.0 ± 0.5) FFU per strain of 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.

Locations

Country	Name	City	State
United States	Research Site	Portland	Oregon
United States	Research Site	South Miami	Florida
United States	Research Site	Stockbridge	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
MedImmune LLC	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 will be reported.	Within 7 days after vaccination	Yes
Secondary	Percentage of Participants With Solicited Symptoms	Solicited symptoms are predefined symptoms or events to be specifically inquired about and assessed daily after vaccine administration up to 14 days after vaccination. The solicited symptoms include 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 will be 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	Yes
Secondary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events between administration of study drug and up to 14 days after vaccination that are absent before treatment or that worsened relative to pre-treatment state. Results will be given for AEs reported within 7 days and 14 days after vaccination.	Within 7 and 14 days after vaccination	Yes
Secondary	Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs)	An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is 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 are serious events between administration of study drug and up to 180 days after the dose that are absent before treatment or that worsen relative to pretreatment state. An NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant. Results will be given for TESAEs and NOCDs reported within 28 days and 180 days after vaccination.	Within 28 and 180 days after vaccination	Yes
Secondary	Percentage of Participants Who Require Antipyretic and/or Analgesic Medication		Within 7 and 14 days after vaccination	Yes