Trial Outcomes & Findings for Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults (NCT NCT01859143)

NCT ID: NCT01859143

Last Updated: 2014-11-10

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

Within 7 days after vaccination

Results posted on

2014-11-10

Participant Flow

One participant randomized to receive placebo received trivalent influenza vaccine on Day 1 instead of placebo and was included in trivalent influenza vaccine group in the safety population.

Participant milestones

Participant milestones
Measure	Trivalent Influenza Vaccine A single dose of 10\^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.	Placebo A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
Overall Study STARTED	240	60
Overall Study COMPLETED	238	60
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Trivalent Influenza Vaccine A single dose of 10\^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.	Placebo A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
Overall Study Lost to Follow-up	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trivalent Influenza Vaccine n=240 Participants A single dose of 10\^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.	Placebo n=60 Participants A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.	Total n=300 Participants Total of all reporting groups
Age, Continuous	33.1 years STANDARD_DEVIATION 9.4 • n=5 Participants	33.6 years STANDARD_DEVIATION 9.0 • n=7 Participants	33.2 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	137 Participants n=5 Participants	34 Participants n=7 Participants	171 Participants n=5 Participants
Sex: Female, Male Male	103 Participants n=5 Participants	26 Participants n=7 Participants	129 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 7 days after vaccination

Population: Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.

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

Outcome measures

Outcome measures
Measure	Trivalent Influenza Vaccine n=241 Participants A single dose of 10\^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.	Placebo n=59 Participants A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)	0.4 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Trivalent Influenza Vaccine n=241 Participants A single dose of 10\^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.	Placebo n=59 Participants A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
Percentage of Participants With Solicited Symptoms Fever: greater than 100 degrees F within 14 days	1.2 percentage of participants	0.0 percentage of participants
Percentage of Participants With Solicited Symptoms Any symptom within 7 days	37.3 percentage of participants	25.4 percentage of participants
Percentage of Participants With Solicited Symptoms Fever: greater than 100 degrees F within 7 days	0.8 percentage of participants	0.0 percentage of participants
Percentage of Participants With Solicited Symptoms Fever: greater than 102 degrees F within 7 days	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Solicited Symptoms Fever: greater than 103 degrees F within 7 days	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Solicited Symptoms Fever: >= 101 degrees F within 14 days	0.8 percentage of participants	0.0 percentage of participants
Percentage of Participants With Solicited Symptoms Fever: greater than 102 degrees F within 14 days	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Solicited Symptoms Fever: greater than 103 degrees F within 14 days	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Solicited Symptoms Runny nose within 14 days	21.6 percentage of participants	11.9 percentage of participants
Percentage of Participants With Solicited Symptoms Sore throat within 14 days	11.2 percentage of participants	6.8 percentage of participants
Percentage of Participants With Solicited Symptoms Cough within 14 days	5.4 percentage of participants	5.1 percentage of participants
Percentage of Participants With Solicited Symptoms Vomiting within 14 days	0.4 percentage of participants	0.0 percentage of participants
Percentage of Participants With Solicited Symptoms Muscle aches within 14 days	3.7 percentage of participants	3.4 percentage of participants
Percentage of Participants With Solicited Symptoms Chills within 14 days	2.5 percentage of participants	0.0 percentage of participants
Percentage of Participants With Solicited Symptoms Decreased activity (tiredness) within 14 days	11.2 percentage of participants	6.8 percentage of participants
Percentage of Participants With Solicited Symptoms Headache within 14 days	16.6 percentage of participants	13.6 percentage of participants
Percentage of Participants With Solicited Symptoms Runny nose within 7 days	20.7 percentage of participants	11.9 percentage of participants
Percentage of Participants With Solicited Symptoms Sore throat within 7 days	9.5 percentage of participants	3.4 percentage of participants
Percentage of Participants With Solicited Symptoms Cough within 7 days	4.6 percentage of participants	5.1 percentage of participants
Percentage of Participants With Solicited Symptoms Vomiting within 7 days	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Solicited Symptoms Muscle aches within 7 days	3.3 percentage of participants	3.4 percentage of participants
Percentage of Participants With Solicited Symptoms Chills within 7 days	1.7 percentage of participants	0.0 percentage of participants
Percentage of Participants With Solicited Symptoms Decreased activity (tiredness) within 7 days	10.0 percentage of participants	6.8 percentage of participants
Percentage of Participants With Solicited Symptoms Headache within 7 days	15.4 percentage of participants	11.9 percentage of participants
Percentage of Participants With Solicited Symptoms Any symptom within 14 days	39.4 percentage of participants	27.1 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Trivalent Influenza Vaccine n=241 Participants A single dose of 10\^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.	Placebo n=59 Participants A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Within 7 days	26 participants	4 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Within 14 days	28 participants	5 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Trivalent Influenza Vaccine n=241 Participants A single dose of 10\^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.	Placebo n=59 Participants A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs) TESAEs within 28 days	1 participants	0 participants
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs) TESAEs within 180 days	1 participants	2 participants
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs) NOCDs within 28 days	0 participants	0 participants
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs) NOCDs within 180 days	0 participants	0 participants

SECONDARY outcome

Timeframe: Within 7 and 14 days after vaccination

Outcome measures

Outcome measures
Measure	Trivalent Influenza Vaccine n=241 Participants A single dose of 10\^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.	Placebo n=59 Participants A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
Percentage of Participants Who Required Antipyretic and/or Analgesic Medication Anti-pyretic and analgesic within 14 days	8.7 percentage of participants	6.8 percentage of participants
Percentage of Participants Who Required Antipyretic and/or Analgesic Medication Anti-pyretic or analgesic within 7 days	9.1 percentage of participants	5.1 percentage of participants
Percentage of Participants Who Required Antipyretic and/or Analgesic Medication Anti-pyretic and analgesic within 7 days	8.7 percentage of participants	5.1 percentage of participants
Percentage of Participants Who Required Antipyretic and/or Analgesic Medication Anti-pyretic or analgesic within 14 days	9.1 percentage of participants	6.8 percentage of participants

Adverse Events

TRIVALENT VACCINE

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

PLACEBO

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TRIVALENT VACCINE n=241 participants at risk A single dose of 10\^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.	PLACEBO n=59 participants at risk A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/241 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.	1.7% 1/59 • Number of events 1 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.
General disorders Non-cardiac chest pain	0.41% 1/241 • Number of events 1 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.	0.00% 0/59 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.
Reproductive system and breast disorders Menorrhagia	0.00% 0/241 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.	1.7% 1/59 • Number of events 1 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.

Other adverse events

Other adverse events
Measure	TRIVALENT VACCINE n=241 participants at risk A single dose of 10\^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.	PLACEBO n=59 participants at risk A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/241 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.	1.7% 1/59 • Number of events 1 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.
Gastrointestinal disorders Diarrhoea	0.41% 1/241 • Number of events 1 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.	1.7% 1/59 • Number of events 1 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.
Gastrointestinal disorders Dyspepsia	0.41% 1/241 • Number of events 1 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.	0.00% 0/59 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.
Gastrointestinal disorders Nausea	1.2% 3/241 • Number of events 3 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.	1.7% 1/59 • Number of events 1 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.
Infections and infestations Acute tonsillitis	0.41% 1/241 • Number of events 1 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.	0.00% 0/59 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.
Infections and infestations Folliculitis	0.41% 1/241 • Number of events 2 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.	0.00% 0/59 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.
Infections and infestations Upper respiratory tract infection	0.83% 2/241 • Number of events 2 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.	0.00% 0/59 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.
Musculoskeletal and connective tissue disorders Back pain	0.41% 1/241 • Number of events 1 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.	0.00% 0/59 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.6% 16/241 • Number of events 16 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.	5.1% 3/59 • Number of events 3 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.
Respiratory, thoracic and mediastinal disorders Nasal discharge discolouration	0.00% 0/241 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.	1.7% 1/59 • Number of events 1 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.
Respiratory, thoracic and mediastinal disorders Sinus congestion	1.7% 4/241 • Number of events 5 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.	0.00% 0/59 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.
Respiratory, thoracic and mediastinal disorders Sneezing	1.2% 3/241 • Number of events 3 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.	0.00% 0/59 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.
Skin and subcutaneous tissue disorders Night sweats	0.41% 1/241 • Number of events 1 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.	1.7% 1/59 • Number of events 1 • Serious Adverse events (SAEs): up to 180 days after vaccination; other adverse events (AEs): up to 14 days after vaccination Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.

Additional Information

Raburn Mallory, MD/Senior Director, Clinical Development

MedImmune, LLC

Phone: 301-398-0000

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 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