Trial Outcomes & Findings for Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2016-2017 Season (NCT NCT02743117)

Results Overview

Percentage of participants with fever defined as oral temperature \>=101 degrees F were reported.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

301 participants

Primary outcome timeframe

Baseline (Day 1) up to Day 8

Results posted on

2017-10-04

Participant Flow

A total of 301 participants were randomized and participated in the study from 02-May-2016 through 30-Nov-2016 at 3 sites in the United States of America (USA).

One participant was considered as screen failure and 300 randomized participants were treated in the study.

Participant milestones

Participant milestones
Measure	Placebo Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.	Monovalent Influenza Vaccine Participants received a single dose of monovalent influenza vaccine \[10\^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains\] by intranasal spray on Day 1.
Overall Study STARTED	60	241
Overall Study Treated	59	241
Overall Study COMPLETED	59	240
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.	Monovalent Influenza Vaccine Participants received a single dose of monovalent influenza vaccine \[10\^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains\] by intranasal spray on Day 1.
Overall Study Lost to Follow-up	0	1
Overall Study Other	1	0

Baseline Characteristics

Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2016-2017 Season

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=59 Participants Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.	Monovalent Influenza Vaccine n=241 Participants Participants received a single dose of monovalent influenza vaccine \[10\^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains\] by intranasal spray on Day 1.	Total n=300 Participants Total of all reporting groups
Age, Continuous	33.2 Years STANDARD_DEVIATION 9.4 • n=5 Participants	33.3 Years STANDARD_DEVIATION 9.5 • n=7 Participants	33.3 Years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	139 Participants n=7 Participants	172 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	102 Participants n=7 Participants	128 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) up to Day 8

Population: The intent-to-treat (ITT) population included all participants that were randomized and treated with investigational product.

Percentage of participants with fever defined as oral temperature \>=101 degrees F were reported.

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.	Monovalent Influenza Vaccine n=241 Participants Participants received a single dose of monovalent influenza vaccine \[10\^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains\] by intranasal spray on Day 1.
Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)	1.7 Percentage of participants	0.4 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Day 8 and Day 15

Population: The ITT population included all participants that were randomized and treated with investigational product.

Solicited symptoms are predefined symptoms or events specifically inquired about and assessed daily after vaccine administration up to 15 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 were reported for all solicited symptoms except fever \>=101 degrees F (reported as primary outcome) up to 8 days after vaccination and all solicited symptoms up to 15 days after vaccination.

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.	Monovalent Influenza Vaccine n=241 Participants Participants received a single dose of monovalent influenza vaccine \[10\^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains\] by intranasal spray on Day 1.
Percentage of Participants With Solicited Symptoms Up to Day 8	33.9 Percentage of participants	25.7 Percentage of participants
Percentage of Participants With Solicited Symptoms Up to Day 15	37.3 Percentage of participants	29.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Day 8 and Day 15

Population: The ITT population included all participants that were randomized and treated with investigational product.

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 were events between administration of study drug and up to 15 days after vaccination that are absent before treatment or that worsened relative to pre-treatment state. Results were given for AEs reported up to 8 days and 15 days after vaccination.

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.	Monovalent Influenza Vaccine n=241 Participants Participants received a single dose of monovalent influenza vaccine \[10\^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains\] by intranasal spray on Day 1.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Up to Day 8	1 Participants	9 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Up to Day 15	1 Participants	14 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Day 29 and Day 181

Population: The ITT population included all participants that were randomized and treated with investigational product.

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 were serious events between administration of study drug and up to 181 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 were given for TESAEs and NOCDs reported up to 29 days and 181 days after vaccination.

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.	Monovalent Influenza Vaccine n=241 Participants Participants received a single dose of monovalent influenza vaccine \[10\^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains\] by intranasal spray on Day 1.
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs) Up to Day 29: TESAEs	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs) Up to Day 29: NOCDs	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs) Up to Day 181: TESAEs	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs) Up to Day 181: NOCDs	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) up to Day 8 and Day 15

Population: The ITT population included all participants that were randomized and treated with investigational product.

Percentage of participants who require antipyretic and/or analgesic medication were reported.

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.	Monovalent Influenza Vaccine n=241 Participants Participants received a single dose of monovalent influenza vaccine \[10\^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains\] by intranasal spray on Day 1.
Percentage of Participants Who Require Antipyretic and/or Analgesic Medication Up to Day 8	3.4 Percentage of participants	1.2 Percentage of participants
Percentage of Participants Who Require Antipyretic and/or Analgesic Medication Up to Day 15	5.1 Percentage of participants	1.7 Percentage of participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Monovalent Influenza Vaccine

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=59 participants at risk Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.	Monovalent Influenza Vaccine n=241 participants at risk Participants received a single dose of monovalent influenza vaccine \[10\^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains\] by intranasal spray on Day 1.
Gastrointestinal disorders Diarrhoea	0.00% 0/59 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181	0.41% 1/241 • Number of events 1 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181
Gastrointestinal disorders Food poisoning	0.00% 0/59 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181	0.41% 1/241 • Number of events 1 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181
Gastrointestinal disorders Nausea	0.00% 0/59 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181	1.2% 3/241 • Number of events 3 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181
General disorders Pyrexia	1.7% 1/59 • Number of events 1 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181	0.41% 1/241 • Number of events 1 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181
Infections and infestations Laryngitis	0.00% 0/59 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181	0.41% 1/241 • Number of events 1 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181
Infections and infestations Pharyngitis	0.00% 0/59 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181	0.41% 1/241 • Number of events 1 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181
Nervous system disorders Dysgeusia	0.00% 0/59 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181	0.41% 1/241 • Number of events 1 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/59 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181	2.1% 5/241 • Number of events 5 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/59 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181	0.83% 2/241 • Number of events 3 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181

Additional Information

Raburn Mallory, MD

MedImmune, LLC

Phone: 301-398-000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on-going studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Publication restrictions are in place

Restriction type: OTHER