Trial Outcomes & Findings for Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults for the 2015-2016 Season (NCT NCT02473510)
NCT ID: NCT02473510
Last Updated: 2016-11-28
Results Overview
Percentage of participants with fever defined as oral temperature \>=101 degrees F were reported.
COMPLETED
PHASE4
301 participants
Baseline (Day 1) up to Day 8
2016-11-28
Participant Flow
A total of 300 participants were randomized and participated in the study from 15-Jun-2015 through 15-Jan-2016 at 3 sites in the United States of America (USA).
Participant milestones
| Measure |
Placebo
Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
|
Trivalent Influenza Vaccine
Participants received a single dose of trivalent influenza vaccine \[10\^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains\] by intranasal spray on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
240
|
|
Overall Study
COMPLETED
|
59
|
238
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
|
Trivalent Influenza Vaccine
Participants received a single dose of trivalent influenza vaccine \[10\^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains\] by intranasal spray on Day 1.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults for the 2015-2016 Season
Baseline characteristics by cohort
| Measure |
Placebo
n=60 Participants
Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
|
Trivalent Influenza Vaccine
n=240 Participants
Participants received a single dose of trivalent influenza vaccine \[10\^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains\] by intranasal spray on Day 1.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.2 Years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
32.3 Years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
31.9 Years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to Day 8Population: 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
| Measure |
Placebo
n=60 Participants
Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
|
Trivalent Influenza Vaccine
n=240 Participants
Participants received a single dose of trivalent influenza vaccine \[10\^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains\] by intranasal spray on Day 1.
|
|---|---|---|
|
Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)
|
0 Percentage of Participant
|
0.4 Percentage of Participant
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 8 and Day 15Population: 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) within 8 days after vaccination and all solicited symptoms within 15 days after vaccination.
Outcome measures
| Measure |
Placebo
n=60 Participants
Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
|
Trivalent Influenza Vaccine
n=240 Participants
Participants received a single dose of trivalent influenza vaccine \[10\^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains\] by intranasal spray on Day 1.
|
|---|---|---|
|
Percentage of Participants With Solicited Symptoms
Up to Day 8
|
20.0 Percentage of Participants
|
36.7 Percentage of Participants
|
|
Percentage of Participants With Solicited Symptoms
Up to Day 15
|
21.7 Percentage of Participants
|
39.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 8 and Day 15Population: 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 within 8 days and 15 days after vaccination.
Outcome measures
| Measure |
Placebo
n=60 Participants
Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
|
Trivalent Influenza Vaccine
n=240 Participants
Participants received a single dose of trivalent influenza vaccine \[10\^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains\] by intranasal spray on Day 1.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Up to Day 8
|
3 Participants
|
13 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Up to Day 15
|
3 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 29 and 181Population: 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 within 29 days and 181 days after vaccination.
Outcome measures
| Measure |
Placebo
n=60 Participants
Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
|
Trivalent Influenza Vaccine
n=240 Participants
Participants received a single dose of trivalent influenza vaccine \[10\^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains\] by intranasal spray on Day 1.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Disease (NOCDs)
Up to Day 29: TESAEs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Disease (NOCDs)
Up to Day 29: NOCDs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Disease (NOCDs)
Up to Day 181: TESAEs
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Disease (NOCDs)
Up to Day 181: NOCDs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 8 and Day 15Population: 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
| Measure |
Placebo
n=60 Participants
Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
|
Trivalent Influenza Vaccine
n=240 Participants
Participants received a single dose of trivalent influenza vaccine \[10\^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains\] by intranasal spray on Day 1.
|
|---|---|---|
|
Percentage of Participants Who Require Antipyretic and/or Analgesic Medication
Up to Day 8
|
0 Percentage of Participants
|
0.4 Percentage of Participants
|
|
Percentage of Participants Who Require Antipyretic and/or Analgesic Medication
Up to Day 15
|
0 Percentage of Participants
|
0.8 Percentage of Participants
|
Adverse Events
Placebo
Trivalent Influenza Vaccine
Serious adverse events
| Measure |
Placebo
n=60 participants at risk
Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
|
Trivalent Influenza Vaccine
n=240 participants at risk
Participants received a single dose of trivalent influenza vaccine \[10\^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains\] by intranasal spray on Day 1.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/60 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181
|
0.42%
1/240 • 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
|
Other adverse events
| Measure |
Placebo
n=60 participants at risk
Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
|
Trivalent Influenza Vaccine
n=240 participants at risk
Participants received a single dose of trivalent influenza vaccine \[10\^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains\] by intranasal spray on Day 1.
|
|---|---|---|
|
Eye disorders
Lacrimation increased
|
0.00%
0/60 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181
|
0.42%
1/240 • 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
Diarrhoea
|
0.00%
0/60 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181
|
0.42%
1/240 • 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%
0/60 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181
|
0.42%
1/240 • 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
Hordeolum
|
0.00%
0/60 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181
|
0.42%
1/240 • 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 streptococcal
|
0.00%
0/60 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181
|
0.42%
1/240 • 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
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/60 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181
|
0.42%
1/240 • 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
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/60 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181
|
0.42%
1/240 • 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
|
3.3%
2/60 • Number of events 2 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181
|
2.1%
5/240 • 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
Productive cough
|
0.00%
0/60 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181
|
0.42%
1/240 • 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
Sneezing
|
0.00%
0/60 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181
|
0.83%
2/240 • Number of events 2 • Adverse Events: From Screening (Day -14) up to Day 15, and Serious Adverse Events: From Screening (Day -14) up to Day 181
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
1/60 • 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
|
0.42%
1/240 • 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
|
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 ongoing 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. The PIs also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER