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

• ClinicalTrials.gov Identifier: NCT01859143
• Recruitment Status: Completed
• First Posted: May 21, 2013
• Results First Posted: November 10, 2014
• Last Update Posted: November 10, 2014
• Sponsor: MedImmune LLC
• Collaborator: AstraZeneca
• Information provided by (Responsible Party): MedImmune LLC

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Influenza; Healthy	Biological: Trivalent Influenza Vaccine; Other: Placebo	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults
• Study Start Date: May 2013
• Actual Primary Completion Date: December 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

Arm	Intervention/treatment
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.
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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Percentage of Participants With Solicited Symptoms [ Time Frame: Within 7 and 14 days after vaccination ]
   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.
2. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Within 7 and 14 days after vaccination ]
   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.
3. Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs) [ Time Frame: Within 28 and 180 days after vaccination ]
   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.
4. Percentage of Participants Who Required Antipyretic and/or Analgesic Medication [ Time Frame: Within 7 and 14 days after vaccination ]

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Florida

Research Site

Miami, Florida, United States

United States, Georgia

Research Site

Stockbridge, Georgia, United States

United States, Oregon

Research Site

Portland, Oregon, United States

Sponsors and Collaborators

MedImmune LLC

AstraZeneca

Investigators

• Study Director: Raburn Mallory, MD; MedImmune LLC

More Information

• Responsible Party: MedImmune LLC
• ClinicalTrials.gov Identifier: NCT01859143
• Other Study ID Numbers: MED-VA-FLUMIST-1156
• First Posted: May 21, 2013
• Results First Posted: November 10, 2014
• Last Update Posted: November 10, 2014
• Last Verified: November 2014

Keywords provided by MedImmune LLC:

Trivalent; Influenza; FluMist Quadrivalent; Vaccine; Prevention; Healthy

Additional relevant MeSH terms:

Influenza, Human; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases