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A Prospective Study to Evaluate the Safety of a New Monovalent Intranasal Influenza Vaccine (MI-MA205)

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ClinicalTrials.gov Identifier: NCT00873912
Recruitment Status : Completed
First Posted : April 2, 2009
Results First Posted : July 13, 2011
Last Update Posted : July 14, 2011
Sponsor:
Information provided by:
MedImmune LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Healthy
Interventions Biological: Monovalent influenza virus vaccine
Biological: Placebo
Enrollment 300
Recruitment Details A total of 300 subjects were randomized into the study between 26May2009 and 27May2009 at 3 sites in the USA.
Pre-assignment Details Each site enrolled and randomized 80 subjects in the monovalent vaccine group and 20 subjects in the placebo group
Arm/Group Title Monovalent Influenza Virus Vaccine Placebo
Hide Arm/Group Description Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1. Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
Period Title: Overall Study
Started 240 60
Completed 237 60
Not Completed 3 0
Reason Not Completed
Withdrawal by Subject             1             0
Lost to Follow-up             2             0
Arm/Group Title Monovalent Influenza Virus Vaccine Placebo Total
Hide Arm/Group Description Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1. Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 240 60 300
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 240 participants 60 participants 300 participants
32.2  (8.1) 30.9  (8.6) 31.9  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 240 participants 60 participants 300 participants
Female
124
  51.7%
33
  55.0%
157
  52.3%
Male
116
  48.3%
27
  45.0%
143
  47.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 240 participants 60 participants 300 participants
Hispanic or Latino
36
  15.0%
10
  16.7%
46
  15.3%
Not Hispanic or Latino
204
  85.0%
50
  83.3%
254
  84.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 240 participants 60 participants 300 participants
American Indian or Alaska Native 7 2 9
Asian 2 2 4
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 18 5 23
White 206 50 256
More than one race 4 1 5
Unknown or Not Reported 0 0 0
Other 3 0 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 240 participants 60 participants 300 participants
240 60 300
1.Primary Outcome
Title Number of Participants Reporting Fever, Defined as Oral Temperature ≥ 101°F
Hide Description The percentage of subjects with fever was compared between the two treatment groups based on the upper limit of the two-sided 95% exact confidence interval (CI) for the rate difference (monovalent vaccine minus placebo). The upper limit of the two-sided 95% CI was evaluated against the pre-specified equivalence criterion of 5 percentage points which corresponded to the following hypotheses: - H0 (null): rate difference ≥ 5 percentage points, - HA (alternative): rate difference < 5 percentage points.
Time Frame Days 1-8 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.
Arm/Group Title Monovalent Influenza Virus Vaccine Placebo
Hide Arm/Group Description:
Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
Overall Number of Participants Analyzed 240 60
Measure Type: Number
Unit of Measure: participants
1 1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Monovalent Influenza Virus Vaccine, Placebo
Comments The percentage of subjects with fever was compared between the two treatment groups based on the upper limit of the two-sided 95% CIs for rate difference (monovalent vaccine minus placebo). The upper limit of the two-sided 95% CI was evaluated against the pre-specified equivalence criterion of 5 percentage points which corresponded to the following hypotheses: - H0 (null): rate difference ≥ 5 percentage points, - HA (alternative): rate difference < 5 percentage points.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Based on similar fever rate with 300 evaluable subjects (240 vaccine and 60 placebo recipients), the study would provide at least 98% power to rule out a rate increase of 5 percentage points assuming the true difference between the treatment groups is zero and the true fever rate is ≤ 1.0%. Power would be lower if the true difference was different from zero.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method score statistic
Comments [Not Specified]
Method of Estimation Estimation Parameter rate difference
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-7.9 to 1.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants Reporting Any Solicited Symptom or at Least One Adverse Event (AE)
Hide Description Solicited symptoms were collected from administration of investigational product through Study Day 15. For this study, solicited symptoms included: fever (> 100°F oral), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity (tiredness), headache.
Time Frame Days 1-8 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.
Arm/Group Title Monovalent Influenza Virus Vaccine Placebo
Hide Arm/Group Description:
Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
Overall Number of Participants Analyzed 240 60
Measure Type: Number
Unit of Measure: participants
Any solicited symptom 97 23
Fever > 100°F 2 1
Fever ≥ 101°F 1 1
Fever > 102°F 0 0
Fever > 103°F 0 0
Runny nose 66 10
Sore throat 33 4
Cough 10 3
Vomiting 1 1
Muscle aches 15 4
Chills 0 0
Decreased activity (tiredness) 18 2
Headache 42 11
Total participants reporting ≥ one AE 27 2
3.Secondary Outcome
Title Number of Participants Reporting Any Solicited Symptom or at Least One AE
Hide Description [Not Specified]
Time Frame Days 1-15 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.
Arm/Group Title Monovalent Influenza Virus Vaccine Placebo
Hide Arm/Group Description:
Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
Overall Number of Participants Analyzed 240 60
Measure Type: Number
Unit of Measure: participants
Any solicited symptom 102 25
Fever > 100°F 3 1
Fever ≥ 101°F 1 1
Fever > 102°F 0 0
Fever > 103°F 0 0
Runny nose 68 11
Sore throat 38 4
Cough 13 3
Vomiting 1 1
Muscle aches 16 4
Chills 1 0
Decreased activity (tiredness) 19 2
Headache 44 13
Total participants reporting ≥ one AE 29 3
4.Secondary Outcome
Title Number of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD)
Hide Description 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 an important 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.
Time Frame Days 1-29 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.
Arm/Group Title Monovalent Influenza Virus Vaccine Placebo
Hide Arm/Group Description:
Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
Overall Number of Participants Analyzed 240 60
Measure Type: Number
Unit of Measure: participants
Total participants reporting ≥ one SAE 0 0
Total participants reporting ≥ one NOCD 0 0
5.Secondary Outcome
Title Number of Participants Reporting at Least One Serious Adverse Event (SAE) or New Onset Chronic Disease (NOCD)
Hide Description 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 an important 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.
Time Frame Days 1-181 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Population includes all subjects who received at least one dose of investigational product and experienced any follow-up for safety. Treatment group was assigned based on the actual investigational product received.
Arm/Group Title Monovalent Influenza Virus Vaccine Placebo
Hide Arm/Group Description:
Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
Overall Number of Participants Analyzed 240 60
Measure Type: Number
Unit of Measure: participants
Total participants reporting ≥ one SAE 2 0
Total participants reporting ≥ one NOCD 0 0
Time Frame From the time that written informed consent was obtained, AEs were collected through Day 15 after vaccination and SAEs were collected through Day 181 after vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Monovalent Influenza Virus Vaccine Placebo
Hide Arm/Group Description Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1. Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
All-Cause Mortality
Monovalent Influenza Virus Vaccine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Monovalent Influenza Virus Vaccine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/240 (0.83%)      0/60 (0.00%)    
Endocrine disorders     
Thyroid disorder † 1  1/240 (0.42%)  1 0/60 (0.00%)  0
Hepatobiliary disorders     
Gallbladder disorder † 1  1/240 (0.42%)  1 0/60 (0.00%)  0
Infections and infestations     
Clostridium difficile colitis † 1  1/240 (0.42%)  1 0/60 (0.00%)  0
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.5%
Monovalent Influenza Virus Vaccine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/240 (9.58%)      3/60 (5.00%)    
Gastrointestinal disorders     
Nausea † 1  2/240 (0.83%)  2 1/60 (1.67%)  1
Abdominal distension † 1  0/240 (0.00%)  0 1/60 (1.67%)  1
Reproductive system and breast disorders     
Menstruation irregular † 1  0/240 (0.00%)  0 1/60 (1.67%)  1
Respiratory, thoracic and mediastinal disorders     
Nasal congestion † 1  17/240 (7.08%)  17 0/60 (0.00%)  0
Sneezing † 1  4/240 (1.67%)  4 0/60 (0.00%)  0
Skin and subcutaneous tissue disorders     
Cold sweat † 1  0/240 (0.00%)  0 1/60 (1.67%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Elissa Malkin, DO
Organization: MedImmune, LLC
Phone: 301-398-0000
EMail: malkine@medimmune.com
Layout table for additonal information
Responsible Party: Elissa Malkin, DO/Dir Clinical Development, MedImmune, LLC
ClinicalTrials.gov Identifier: NCT00873912    
Other Study ID Numbers: MI-MA205
First Submitted: April 1, 2009
First Posted: April 2, 2009
Results First Submitted: October 8, 2010
Results First Posted: July 13, 2011
Last Update Posted: July 14, 2011