Trial Outcomes & Findings for A Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults (NCT NCT01579916)
NCT ID: NCT01579916
Last Updated: 2014-02-03
Results Overview
A comparison of the rate of fever, defined as oral temperature greater than or equal to 101 degrees Fahrenheit, reported during the 7 days post administration of investigational product between the trivalent influenza virus vaccine and placebo groups.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
303 participants
Primary outcome timeframe
Study Days 1 - 8
Results posted on
2014-02-03
Participant Flow
303 participants participated in the study from 21May2012 (date of first written informed consent) through 30Nov2012 (date of last participant visit).
Eligible participants were randomly assigned in a 4:1 fashion to receive a single dose of trivalent vaccine or placebo by intranasal spray. Randomization was stratified by site.
Participant milestones
| Measure |
Trivalent Influenza Virus Vaccine
Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
|
Placebo
Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
242
|
61
|
|
Overall Study
COMPLETED
|
234
|
59
|
|
Overall Study
NOT COMPLETED
|
8
|
2
|
Reasons for withdrawal
| Measure |
Trivalent Influenza Virus Vaccine
Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
|
Placebo
Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults
Baseline characteristics by cohort
| Measure |
Trivalent Influenza Virus Vaccine
n=242 Participants
Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
|
Placebo
n=61 Participants
Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
|
TOTAL
n=303 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.7 Years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
32.0 Years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
32.6 Years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study Days 1 - 8Population: All participants who received a single dose of investigational product (trivalent influenza vaccine = 241; placebo = 60).
A comparison of the rate of fever, defined as oral temperature greater than or equal to 101 degrees Fahrenheit, reported during the 7 days post administration of investigational product between the trivalent influenza virus vaccine and placebo groups.
Outcome measures
| Measure |
Trivalent Influenza Virus Vaccine
n=241 Participants
Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
|
Placebo
n=60 Participants
Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting Fever Within 7 Days Post Vaccination
|
0.0 Percentage of Participants
|
1.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Study Days 1- 8Population: All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60)
Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.
Outcome measures
| Measure |
Trivalent Influenza Virus Vaccine
n=241 Participants
Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
|
Placebo
n=60 Participants
Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination
Any symptom
|
38.6 Percentage of Participants
|
20.0 Percentage of Participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination
Fever > 100 degrees Fahrenheit
|
0.8 Percentage of Participants
|
1.7 Percentage of Participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination
Fever >/= 101 degrees Fahrenheit
|
0.0 Percentage of Participants
|
1.7 Percentage of Participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination
Fever > 102 degrees Fahrenheit
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination
Fever > 103 degrees Fahrenheit
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination
Runny nose
|
18.3 Percentage of Participants
|
8.3 Percentage of Participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination
Sore throat
|
14.1 Percentage of Participants
|
5.0 Percentage of Participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination
Cough
|
4.1 Percentage of Participants
|
1.7 Percentage of Participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination
Vomiting
|
0.4 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination
Muscle aches
|
5.0 Percentage of Participants
|
3.3 Percentage of Participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination
Chills
|
1.2 Percentage of Participants
|
3.3 Percentage of Participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination
Decreased activity (tiredness)
|
8.7 Percentage of Participants
|
6.7 Percentage of Participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination
Headache
|
15.8 Percentage of Participants
|
10.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Study Days 1 - 8Population: All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).
Percentage of participants reporting at least one AE between Days 1 and 8. Investigational product was administered on Day 1.
Outcome measures
| Measure |
Trivalent Influenza Virus Vaccine
n=241 Participants
Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
|
Placebo
n=60 Participants
Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting Any Adverse Event (AE) Within 7 Days Post Vaccination
|
7.5 Percentage of participants
|
6.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Study Days 1 - 15Population: All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).
Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.
Outcome measures
| Measure |
Trivalent Influenza Virus Vaccine
n=241 Participants
Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
|
Placebo
n=60 Participants
Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination
Perecentage of participants reporting any symptom
|
41.5 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination
Fever > 100 degrees Fahrenheit
|
1.2 Percentage of participants
|
1.7 Percentage of participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination
Fever >/= 101 degrees Fahrenheit
|
0.4 Percentage of participants
|
1.7 Percentage of participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination
Fever > 102 degrees Fahrenheit
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination
Fever > 103 degrees Fahrenheit
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination
Runny nose
|
19.1 Percentage of participants
|
13.3 Percentage of participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination
Sore throat
|
14.9 Percentage of participants
|
5.0 Percentage of participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination
Cough
|
5.4 Percentage of participants
|
3.3 Percentage of participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination
Vomiting
|
0.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination
Muscle aches
|
5.8 Percentage of participants
|
3.3 Percentage of participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination
Chills
|
1.2 Percentage of participants
|
3.3 Percentage of participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination
Decreased activity (tiredness)
|
8.7 Percentage of participants
|
8.3 Percentage of participants
|
|
Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination
Headache
|
17.4 Percentage of participants
|
11.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Study Days 1 - 15Population: All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).
Percentage of participants reporting at least one AE between Days 1 and 15. Investigational product was administered on Day 1.
Outcome measures
| Measure |
Trivalent Influenza Virus Vaccine
n=241 Participants
Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
|
Placebo
n=60 Participants
Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting Any Adverse Event (AE) Within 14 Days Post Vaccination
|
7.9 Percentage of participants
|
6.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Study Days 1 - 29Population: All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).
Percentage of participants reporting at least one SAE between Days 1 and 29. Investigational product was administered on Day 1.
Outcome measures
| Measure |
Trivalent Influenza Virus Vaccine
n=241 Participants
Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
|
Placebo
n=60 Participants
Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 28 Days Post Vaccination
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Study Days 1 - 181Population: All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).
Percentage of participants reporting at least one SAE between Days 1 and 181. Investigational product was administered on Day 1.
Outcome measures
| Measure |
Trivalent Influenza Virus Vaccine
n=241 Participants
Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
|
Placebo
n=60 Participants
Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 180 Days Post Vaccination
|
0.4 Percentage of participants
|
1.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Study Days 1 - 29Population: All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).
An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant. Such events were assessed between Day 1 and Day 29. Investigational product was administered on Day 1.
Outcome measures
| Measure |
Trivalent Influenza Virus Vaccine
n=241 Participants
Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
|
Placebo
n=60 Participants
Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Study Days 1 - 181Population: All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).
An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant. Such events were assessed between Day 1 and Day 181. Investigational product was administered on Day 1.
Outcome measures
| Measure |
Trivalent Influenza Virus Vaccine
n=241 Participants
Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
|
Placebo
n=60 Participants
Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 180 Days Post Vaccination
|
0.4 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Study Days 1 - 8Population: All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).
Percentage of participants who used an antipyretic or analgesic agent between Days 1 and 8. Investigational product administration occurred on Day 1.
Outcome measures
| Measure |
Trivalent Influenza Virus Vaccine
n=241 Participants
Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
|
Placebo
n=60 Participants
Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 7 Days Post Vaccination
|
2.1 Percentage of Participants
|
3.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Study Days 1 - 15Population: All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).
Percentage of participants who used an antipyretic or analgesic agent between Days 1 and 15. Investigational product administration occurred on Day 1.
Outcome measures
| Measure |
Trivalent Influenza Virus Vaccine
n=241 Participants
Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
|
Placebo
n=60 Participants
Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 14 Days Post Vaccination
|
2.1 Percentage of Participants
|
3.3 Percentage of Participants
|
Adverse Events
Trivalent Influenza Virus Vaccine
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trivalent Influenza Virus Vaccine
n=241 participants at risk
Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
|
Placebo
n=60 participants at risk
Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.00%
0/241 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
1.7%
1/60 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/241 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
1.7%
1/60 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
|
Psychiatric disorders
Completed suicide
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
0.00%
0/60 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
Other adverse events
| Measure |
Trivalent Influenza Virus Vaccine
n=241 participants at risk
Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
|
Placebo
n=60 participants at risk
Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
0.00%
0/60 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
3/241 • Number of events 3 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
1.7%
1/60 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
|
Gastrointestinal disorders
Nausea
|
0.83%
2/241 • Number of events 2 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
1.7%
1/60 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
|
Infections and infestations
Herpes simplex
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
0.00%
0/60 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
1.7%
1/60 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
|
Nervous system disorders
Dizziness
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
0.00%
0/60 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
|
Nervous system disorders
Migraine
|
0.83%
2/241 • Number of events 2 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
0.00%
0/60 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
|
Nervous system disorders
Post-traumatic headache
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
0.00%
0/60 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
|
Psychiatric disorders
Insomnia
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
0.00%
0/60 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
0.00%
0/60 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.41%
1/241 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
0.00%
0/60 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.1%
5/241 • Number of events 6 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
1.7%
1/60 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.2%
3/241 • Number of events 3 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
1.7%
1/60 • Number of events 1 • Adverse events were collected from the time of investigational product administration through Day 15. Serious adverse events were collected from the time of study drug administration through Day 181.
|
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