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Trial record 3 of 10 for:    Oocyte Maturation Defect 2

A Prospective Study to Evaluate the Safety of a New Trivalent Intranasal Influenza Vaccine (MI-MA182)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00677820
Recruitment Status : Completed
First Posted : May 15, 2008
Results First Posted : September 15, 2010
Last Update Posted : October 22, 2010
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 Influenza
Interventions Biological: Trivalent influenza virus vaccine
Biological: Placebo
Enrollment 300
Recruitment Details A total of 300 subjects were enrolled and randomized in the study between 09Jun2008 and 10Jun2008 at 3 sites in the USA.
Pre-assignment Details  
Arm/Group Title Trivalent Influenza Virus Vaccine Placebo
Hide Arm/Group Description Frozen trivalent vaccine containing the 3 new strains 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 each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0. 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 0.
Period Title: Overall Study
Started 240 60
Completed 239 60
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Arm/Group Title Trivalent Influenza Virus Vaccine Placebo Total
Hide Arm/Group Description Frozen trivalent vaccine containing the 3 new strains 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 each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0. 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 0. 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
31.2  (8.3) 32.0  (9.3) 31.3  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 240 participants 60 participants 300 participants
Female
151
  62.9%
43
  71.7%
194
  64.7%
Male
89
  37.1%
17
  28.3%
106
  35.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 240 participants 60 participants 300 participants
Hispanic or Latino
39
  16.3%
15
  25.0%
54
  18.0%
Not Hispanic or Latino
201
  83.8%
45
  75.0%
246
  82.0%
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 1 1 2
Asian 5 2 7
Native Hawaiian or Other Pacific Islander 1 0 1
Black or African American 13 4 17
White 210 49 259
More than one race 4 2 6
Other 6 2 8
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 Subjects Reporting Fever
Hide Description Fever was defined as oral temperature greater than or equal to 101 degrees Fahrenheit.
Time Frame Days 0-7
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population Evaluable for Solicited Symptoms were subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.
Arm/Group Title Trivalent Influenza Virus Vaccine Placebo
Hide Arm/Group Description:
Frozen trivalent vaccine containing the 3 new strains 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 each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
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 0.
Overall Number of Participants Analyzed 240 60
Measure Type: Number
Unit of Measure: participants
3 0
2.Secondary Outcome
Title Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7
Hide Description [Not Specified]
Time Frame Days 0-7
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population Evaluable for Solicited Symptoms were subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.
Arm/Group Title Trivalent Influenza Virus Vaccine Placebo
Hide Arm/Group Description:
Frozen trivalent vaccine containing the 3 new strains 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 each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
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 0.
Overall Number of Participants Analyzed 240 59
Measure Type: Number
Unit of Measure: participants
Any solicited symptom 101 20
Fever > 100F 4 1
Fever >= 101F 3 0
Fever > 102F 0 0
Fever > 103F 0 0
Runny nose 52 6
Sore throat 32 7
Cough 7 2
Vomiting 2 0
Muscle aches 8 2
Chills 5 2
Decreased activity 20 5
Headache 41 8
3.Secondary Outcome
Title Number of Subjects Reporting Any Adverse Event (AE) Post-treatment
Hide Description [Not Specified]
Time Frame Days 0-7
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.
Arm/Group Title Trivalent Influenza Virus Vaccine Placebo
Hide Arm/Group Description:
Frozen trivalent vaccine containing the 3 new strains 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 each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
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 0.
Overall Number of Participants Analyzed 240 60
Measure Type: Number
Unit of Measure: participants
17 3
4.Secondary Outcome
Title Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14
Hide Description [Not Specified]
Time Frame Days 0-14
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population Evaluable for Solicited Symptoms were subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.
Arm/Group Title Trivalent Influenza Virus Vaccine Placebo
Hide Arm/Group Description:
Frozen trivalent vaccine containing the 3 new strains 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 each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
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 0.
Overall Number of Participants Analyzed 240 59
Measure Type: Number
Unit of Measure: participants
Any solicited symptom 108 27
Fever > 100F 4 2
Fever >= 101F 3 0
Fever > 102F 0 0
Fever > 103F 0 0
Runny nose 58 7
Sore throat 37 8
Cough 10 4
Vomiting 3 1
Muscle aches 12 3
Chills 5 3
Decreased activity 24 5
Headache 44 14
5.Secondary Outcome
Title Number of Subjects Reporting Any AEs Post Treatment
Hide Description [Not Specified]
Time Frame Days 0-14
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.
Arm/Group Title Trivalent Influenza Virus Vaccine Placebo
Hide Arm/Group Description:
Frozen trivalent vaccine containing the 3 new strains 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 each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
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 0.
Overall Number of Participants Analyzed 240 60
Measure Type: Number
Unit of Measure: participants
20 5
6.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC)
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 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 SNMC was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.

Time Frame Days 0-28
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.
Arm/Group Title Trivalent Influenza Virus Vaccine Placebo
Hide Arm/Group Description:
Frozen trivalent vaccine containing the 3 new strains 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 each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
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 0.
Overall Number of Participants Analyzed 240 60
Measure Type: Number
Unit of Measure: participants
Total subjects reporting > 1 SAE 1 0
Total subjects reporting > 1 SNMC 0 0
7.Secondary Outcome
Title Number of Subjects Reporting SAEs and SNMCs
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 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 SNMC was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant.

Time Frame Days 0-180
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.
Arm/Group Title Trivalent Influenza Virus Vaccine Placebo
Hide Arm/Group Description:
Frozen trivalent vaccine containing the 3 new strains 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 each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0.
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 0.
Overall Number of Participants Analyzed 240 60
Measure Type: Number
Unit of Measure: participants
Total subjects reporting > 1 SAE 3 1
Total subjects reporting > 1 SNMC 0 1
Time Frame Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Adverse Event Reporting Description Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
 
Arm/Group Title Trivalent Influenza Virus Vaccine Placebo
Hide Arm/Group Description Frozen trivalent vaccine containing the 3 new strains 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 each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0. 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 0.
All-Cause Mortality
Trivalent Influenza Virus Vaccine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Trivalent Influenza Virus Vaccine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/240 (1.25%)      1/60 (1.67%)    
Gastrointestinal disorders     
Abdominal Pain  1  1/240 (0.42%)  1 0/60 (0.00%)  0
Injury, poisoning and procedural complications     
Joint Sprain  1  0/240 (0.00%)  0 1/60 (1.67%)  1
Multiple Fractures  1  2/240 (0.83%)  2 0/60 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.5%
Trivalent Influenza Virus Vaccine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/240 (5.00%)      5/60 (8.33%)    
Ear and labyrinth disorders     
Ear Pain  1  0/240 (0.00%)  0 1/60 (1.67%)  1
Gastrointestinal disorders     
Abdominal Pain Upper  1  2/240 (0.83%)  2 0/60 (0.00%)  0
Diarrhoea  1  1/240 (0.42%)  1 1/60 (1.67%)  1
Dry Mouth  1  0/240 (0.00%)  0 1/60 (1.67%)  1
Nausea  1  2/240 (0.83%)  2 1/60 (1.67%)  1
Retching  1  0/240 (0.00%)  0 1/60 (1.67%)  1
Respiratory, thoracic and mediastinal disorders     
Nasal Congestion  1  4/240 (1.67%)  4 1/60 (1.67%)  1
Sneezing  1  3/240 (1.25%)  3 0/60 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
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 restricion is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Name/Title: Raburn Mallory, MD/ Sr Dir Clinical Development
Organization: MedImmune LLC, an affiliate of AstraZeneca
Phone: 301-398-0000
Responsible Party: Raburn Mallory M.D.\Senior Director, Clinical Development, MedImmune LLC, an affiliate of AstraZeneca AB
ClinicalTrials.gov Identifier: NCT00677820     History of Changes
Other Study ID Numbers: MI-MA182
First Submitted: May 13, 2008
First Posted: May 15, 2008
Results First Submitted: August 20, 2010
Results First Posted: September 15, 2010
Last Update Posted: October 22, 2010