Trial Outcomes & Findings for A Clinical Study to Assess the Safety of a New Influenza Vaccine (NCT NCT01104493)
NCT ID: NCT01104493
Last Updated: 2011-07-18
Results Overview
A comparison of the rate of fever (oral temperature ≥ 101°F) reported during the 7 days post administration of investigational product between the monovalent vaccine and placebo groups.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
300 participants
Primary outcome timeframe
Study Days 1-8
Results posted on
2011-07-18
Participant Flow
Three investigators at 3 clinical research units in the United States of America (USA) enrolled 300 subjects in May, 2010.
Participant milestones
| Measure |
Monovalent Influenza Virus Vaccine
Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
|
Placebo
Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
240
|
60
|
|
Overall Study
COMPLETED
|
240
|
58
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Monovalent Influenza Virus Vaccine
Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
|
Placebo
Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
A Clinical Study to Assess the Safety of a New Influenza Vaccine
Baseline characteristics by cohort
| Measure |
Monovalent Influenza Virus Vaccine
n=240 Participants
Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
|
Placebo
n=60 Participants
Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
32.5 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
32.4 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
32.5 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study Days 1-8Population: All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)
A comparison of the rate of fever (oral temperature ≥ 101°F) reported during the 7 days post administration of investigational product between the monovalent vaccine and placebo groups.
Outcome measures
| Measure |
Monovalent Influenza Virus Vaccine
n=240 Participants
Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
|
Placebo
n=60 Participants
Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting Fever, Defined as Oral Temperature ≥ 101°F
|
0.4 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Study Days 1-8Population: All subjects who received a single dose of investigational product (monovalent vaccine = 240; 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 |
Monovalent Influenza Virus Vaccine
n=240 Participants
Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
|
Placebo
n=60 Participants
Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting Any Solicited Symptom
Any symptom
|
33.8 Percentage of participants
|
40.0 Percentage of participants
|
|
Percentage of Participants Reporting Any Solicited Symptom
Fever > 100F
|
0.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Any Solicited Symptom
Fever > 102F
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Any Solicited Symptom
Fever > 103F
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Any Solicited Symptom
Runny nose
|
13.3 Percentage of participants
|
18.3 Percentage of participants
|
|
Percentage of Participants Reporting Any Solicited Symptom
Sore throat
|
8.8 Percentage of participants
|
5.0 Percentage of participants
|
|
Percentage of Participants Reporting Any Solicited Symptom
Cough
|
7.5 Percentage of participants
|
6.7 Percentage of participants
|
|
Percentage of Participants Reporting Any Solicited Symptom
Vomiting
|
0.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Any Solicited Symptom
Muscle aches
|
5.8 Percentage of participants
|
3.3 Percentage of participants
|
|
Percentage of Participants Reporting Any Solicited Symptom
Chills
|
2.5 Percentage of participants
|
1.7 Percentage of participants
|
|
Percentage of Participants Reporting Any Solicited Symptom
Decreased activity (tiredness)
|
8.3 Percentage of participants
|
6.7 Percentage of participants
|
|
Percentage of Participants Reporting Any Solicited Symptom
Headache
|
16.7 Percentage of participants
|
16.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Study Days 1-8Population: All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)
An adverse event (AE) was defined as: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
Monovalent Influenza Virus Vaccine
n=240 Participants
Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
|
Placebo
n=60 Participants
Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting Any Adverse Event.
|
3.8 Percentage of participants
|
3.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Study Days 1-15Population: All subjects who received a single dose of investigational product (monovalent vaccine = 240; 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 |
Monovalent Influenza Virus Vaccine
n=240 Participants
Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
|
Placebo
n=60 Participants
Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting Any Solicited Symptom.
Decreased activity (tiredness)
|
8.8 Percentage of participants
|
8.3 Percentage of participants
|
|
Percentage of Participants Reporting Any Solicited Symptom.
Any Symptom
|
38.3 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Reporting Any Solicited Symptom.
Fever > 100F
|
1.7 Percentage of participants
|
1.7 Percentage of participants
|
|
Percentage of Participants Reporting Any Solicited Symptom.
Fever ≥ 101F
|
0.8 Percentage of participants
|
1.7 Percentage of participants
|
|
Percentage of Participants Reporting Any Solicited Symptom.
Fever > 102F
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Any Solicited Symptom.
Fever > 103F
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Any Solicited Symptom.
Runny nose
|
17.1 Percentage of participants
|
21.7 Percentage of participants
|
|
Percentage of Participants Reporting Any Solicited Symptom.
Sore throat
|
10.8 Percentage of participants
|
8.3 Percentage of participants
|
|
Percentage of Participants Reporting Any Solicited Symptom.
Cough
|
8.8 Percentage of participants
|
6.7 Percentage of participants
|
|
Percentage of Participants Reporting Any Solicited Symptom.
Vomiting
|
1.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Any Solicited Symptom.
Muscle aches
|
7.5 Percentage of participants
|
6.7 Percentage of participants
|
|
Percentage of Participants Reporting Any Solicited Symptom.
Chills
|
3.3 Percentage of participants
|
1.7 Percentage of participants
|
|
Percentage of Participants Reporting Any Solicited Symptom.
Headache
|
19.2 Percentage of participants
|
25.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Study Days 1-15Population: All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)
An adverse event (AE) was defined as: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
Monovalent Influenza Virus Vaccine
n=240 Participants
Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
|
Placebo
n=60 Participants
Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting Any Adverse Event.
|
4.2 Percentage of participants
|
3.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Study Days 1-29Population: All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)
SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were a medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.
Outcome measures
| Measure |
Monovalent Influenza Virus Vaccine
n=240 Participants
Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
|
Placebo
n=60 Participants
Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD), Study Days 1-29
Total participants reporting ≥ one SAE
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD), Study Days 1-29
Total participants reporting ≥ one NOCD
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Study Days 1-181Population: All subjects who received a single dose of investigational product (monovalent vaccine = 240; placebo = 60)
SAEs were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly/birth defect in the offspring of a study participant; or were a medical event that may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.
Outcome measures
| Measure |
Monovalent Influenza Virus Vaccine
n=240 Participants
Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
|
Placebo
n=60 Participants
Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Percentage of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD), Study Days 1-181
Total participants reporting ≥ one SAE
|
1.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD), Study Days 1-181
Total participants reporting ≥ one NOCD
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
Adverse Events
Monovalent Influenza Virus Vaccine
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Monovalent Influenza Virus Vaccine
n=240 participants at risk
Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
|
Placebo
n=60 participants at risk
Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Gastrointestinal disorders
oesophageal perforation
|
0.42%
1/240 • Number of events 1 • From the time that written informed consent was obtained, adverse events were collected through Study Day 15 after receipt of investigational product and serious adverse events were collected through Study Day 181 after receipt of investigational product.
|
0.00%
0/60 • From the time that written informed consent was obtained, adverse events were collected through Study Day 15 after receipt of investigational product and serious adverse events were collected through Study Day 181 after receipt of investigational product.
|
|
Infections and infestations
diverticulitis
|
0.42%
1/240 • Number of events 1 • From the time that written informed consent was obtained, adverse events were collected through Study Day 15 after receipt of investigational product and serious adverse events were collected through Study Day 181 after receipt of investigational product.
|
0.00%
0/60 • From the time that written informed consent was obtained, adverse events were collected through Study Day 15 after receipt of investigational product and serious adverse events were collected through Study Day 181 after receipt of investigational product.
|
|
Musculoskeletal and connective tissue disorders
rotator cuff syndrome
|
0.42%
1/240 • Number of events 1 • From the time that written informed consent was obtained, adverse events were collected through Study Day 15 after receipt of investigational product and serious adverse events were collected through Study Day 181 after receipt of investigational product.
|
0.00%
0/60 • From the time that written informed consent was obtained, adverse events were collected through Study Day 15 after receipt of investigational product and serious adverse events were collected through Study Day 181 after receipt of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
uterine leiomyoma
|
0.42%
1/240 • Number of events 1 • From the time that written informed consent was obtained, adverse events were collected through Study Day 15 after receipt of investigational product and serious adverse events were collected through Study Day 181 after receipt of investigational product.
|
0.00%
0/60 • From the time that written informed consent was obtained, adverse events were collected through Study Day 15 after receipt of investigational product and serious adverse events were collected through Study Day 181 after receipt of investigational product.
|
|
Reproductive system and breast disorders
menometrorrhagia
|
0.42%
1/240 • Number of events 1 • From the time that written informed consent was obtained, adverse events were collected through Study Day 15 after receipt of investigational product and serious adverse events were collected through Study Day 181 after receipt of investigational product.
|
0.00%
0/60 • From the time that written informed consent was obtained, adverse events were collected through Study Day 15 after receipt of investigational product and serious adverse events were collected through Study Day 181 after receipt of investigational product.
|
Other adverse events
| Measure |
Monovalent Influenza Virus Vaccine
n=240 participants at risk
Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
|
Placebo
n=60 participants at risk
Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.7%
4/240 • Number of events 4 • From the time that written informed consent was obtained, adverse events were collected through Study Day 15 after receipt of investigational product and serious adverse events were collected through Study Day 181 after receipt of investigational product.
|
1.7%
1/60 • Number of events 2 • From the time that written informed consent was obtained, adverse events were collected through Study Day 15 after receipt of investigational product and serious adverse events were collected through Study Day 181 after receipt of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/240 • From the time that written informed consent was obtained, adverse events were collected through Study Day 15 after receipt of investigational product and serious adverse events were collected through Study Day 181 after receipt of investigational product.
|
1.7%
1/60 • Number of events 1 • From the time that written informed consent was obtained, adverse events were collected through Study Day 15 after receipt of investigational product and serious adverse events were collected through Study Day 181 after receipt of investigational product.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/240 • From the time that written informed consent was obtained, adverse events were collected through Study Day 15 after receipt of investigational product and serious adverse events were collected through Study Day 181 after receipt of investigational product.
|
1.7%
1/60 • Number of events 1 • From the time that written informed consent was obtained, adverse events were collected through Study Day 15 after receipt of investigational product and serious adverse events were collected through Study Day 181 after receipt of investigational product.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.83%
2/240 • Number of events 3 • From the time that written informed consent was obtained, adverse events were collected through Study Day 15 after receipt of investigational product and serious adverse events were collected through Study Day 181 after receipt of investigational product.
|
0.00%
0/60 • From the time that written informed consent was obtained, adverse events were collected through Study Day 15 after receipt of investigational product and serious adverse events were collected through Study Day 181 after receipt of investigational product.
|
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.
- Publication restrictions are in place
Restriction type: OTHER