Trial Outcomes & Findings for Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2017-2018 Season (NCT NCT03158038)
NCT ID: NCT03158038
Last Updated: 2019-01-04
Results Overview
Percentage of participants with fever defined as oral temperature \>=101 degrees F were reported.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
300 participants
Primary outcome timeframe
Baseline (Day 1) up to Day 8
Results posted on
2019-01-04
Participant Flow
The study was conducted from 30 May 2017 to 14 Dec 2017 at 2 sites in the United States of America (USA).
A total of 300 participants were randomized and participated in the study.
Participant milestones
| Measure |
Monovalent Influenza Vaccine
Participants received a single dose of monovalent influenza vaccine \[10\^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strain\] by intranasal spray on Day 1.
|
Placebo
Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
240
|
60
|
|
Overall Study
COMPLETED
|
240
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The ITT population included all participants who were randomized and treated with investigational product.
Baseline characteristics by cohort
| Measure |
Monovalent Influenza Vaccine
n=240 Participants
Participants received a single dose of monovalent influenza vaccine \[10\^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strain\] by intranasal spray on Day 1.
|
Placebo
n=60 Participants
Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.9 Years
STANDARD_DEVIATION 9.5 • n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
32.5 Years
STANDARD_DEVIATION 10.5 • n=7 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
30.4 Years
STANDARD_DEVIATION 9.8 • n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
|
Sex: Female, Male
Female
|
138 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
33 Participants
n=7 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
171 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
|
Sex: Female, Male
Male
|
102 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
27 Participants
n=7 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
129 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
3 Participants
n=7 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
16 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
227 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
57 Participants
n=7 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
284 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
0 Participants
n=7 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
0 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
0 Participants
n=7 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
1 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
1 Participants
n=7 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
4 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
0 Participants
n=7 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
0 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
6 Participants
n=7 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
42 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
|
Race (NIH/OMB)
White
|
191 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
52 Participants
n=7 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
243 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
1 Participants
n=7 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
9 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
0 Participants
n=7 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
1 Participants
n=5 Participants • The ITT population included all participants who were randomized and treated with investigational product.
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to Day 8Population: The intent-to-treat (ITT) population included all participants who were randomized and treated with investigational product.
Percentage of participants with fever defined as oral temperature \>=101 degrees F were reported.
Outcome measures
| Measure |
Monovalent Influenza Vaccine
n=240 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.
|
Placebo
n=60 Participants
Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
|
|---|---|---|
|
Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 8 and Day 15Population: The ITT population included all participants who 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
| Measure |
Monovalent Influenza Vaccine
n=240 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.
|
Placebo
n=60 Participants
Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
|
|---|---|---|
|
Percentage of Participants With Solicited Symptoms
Up to Day 8
|
27.9 Percentage of Participants
|
26.7 Percentage of Participants
|
|
Percentage of Participants With Solicited Symptoms
Up to Day 15
|
32.1 Percentage of Participants
|
31.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 8 and Day 15Population: The ITT population included all participants who 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
| Measure |
Monovalent Influenza Vaccine
n=240 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.
|
Placebo
n=60 Participants
Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Up to Day 8
|
13 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Up to Day 15
|
19 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 29 and Day 181Population: The ITT population included all participants who 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 serious adverse event (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
| Measure |
Monovalent Influenza Vaccine
n=240 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.
|
Placebo
n=60 Participants
Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs)
TESAEs: Up to Day 29
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs)
NOCDs: Up to Day 29
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs)
TESAEs: Up to Day 181
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs)
NOCDs: Up to Day 181
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 8 and Day 15Population: The ITT population included all participants who were randomized and treated with investigational product.
Percentage of participants who require antipyretic and/or analgesic medication were reported.
Outcome measures
| Measure |
Monovalent Influenza Vaccine
n=240 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.
|
Placebo
n=60 Participants
Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
|
|---|---|---|
|
Percentage of Participants Who Require Antipyretic and/or Analgesic Medication
Up to Day 8
|
2.1 Percentage of participants
|
1.7 Percentage of participants
|
|
Percentage of Participants Who Require Antipyretic and/or Analgesic Medication
Up to Day 15
|
3.3 Percentage of participants
|
6.7 Percentage of participants
|
Adverse Events
Monovalent Influenza Vaccine
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Monovalent Influenza Vaccine
n=240 participants at risk
Participants received a single dose of monovalent influenza vaccine \[10\^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strain\] by intranasal spray on Day 1.
|
Placebo
n=60 participants at risk
Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
|
|---|---|---|
|
Reproductive system and breast disorders
Endometriosis
|
0.42%
1/240 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
0.00%
0/60 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
Other adverse events
| Measure |
Monovalent Influenza Vaccine
n=240 participants at risk
Participants received a single dose of monovalent influenza vaccine \[10\^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 1 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strain\] by intranasal spray on Day 1.
|
Placebo
n=60 participants at risk
Participants received a single dose of placebo matching with monovalent influenza vaccine by intranasal spray on Day 1.
|
|---|---|---|
|
Ear and labyrinth disorders
Ear congestion
|
0.42%
1/240 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
0.00%
0/60 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
|
Ear and labyrinth disorders
Ear pain
|
0.42%
1/240 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
0.00%
0/60 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
|
Ear and labyrinth disorders
Tinnitus
|
0.42%
1/240 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
0.00%
0/60 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.42%
1/240 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
0.00%
0/60 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
|
Gastrointestinal disorders
Diarrhoea
|
0.42%
1/240 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
0.00%
0/60 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
|
Infections and infestations
Ear infection
|
0.42%
1/240 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
0.00%
0/60 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
|
Infections and infestations
Laryngitis
|
0.83%
2/240 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
0.00%
0/60 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
|
Infections and infestations
Viral infection
|
0.00%
0/240 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
1.7%
1/60 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.42%
1/240 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
0.00%
0/60 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.42%
1/240 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
0.00%
0/60 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
|
Psychiatric disorders
Insomnia
|
0.42%
1/240 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
0.00%
0/60 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.42%
1/240 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
0.00%
0/60 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.83%
2/240 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
0.00%
0/60 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.2%
3/240 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
0.00%
0/60 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.42%
1/240 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
0.00%
0/60 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.42%
1/240 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
0.00%
0/60 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.42%
1/240 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
0.00%
0/60 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.83%
2/240 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
0.00%
0/60 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.42%
1/240 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
0.00%
0/60 • Adverse Events: Baseline (Day 1) up to Day 15, and Serious Adverse Events: Baseline (Day 1) up to Day 181
|
Additional Information
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