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

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00677820
First received: May 13, 2008
Last updated: October 12, 2010
Last verified: October 2010
History of Changes
Results First Received: August 20, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: Trivalent influenza virus vaccine
Biological: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Trivalent Influenza Virus Vaccine 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 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.

Participant Flow:   Overall Study
    Trivalent Influenza Virus Vaccine     Placebo  
STARTED     240     60  
COMPLETED     239     60  
NOT COMPLETED     1     0  
Lost to Follow-up                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Trivalent Influenza Virus Vaccine 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 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 Total of all reporting groups

Baseline Measures
    Trivalent Influenza Virus Vaccine     Placebo     Total  
Number of Participants  
[units: participants]
 		  240     60     300  
Age  
[units: years]
Mean ± Standard Deviation 		  31.2  ± 8.3     32.0  ± 9.3     31.3  ± 8.5  
Gender  
[units: participants]
 		     
Female     151     43     194  
Male     89     17     106  
Ethnicity (NIH/OMB)  
[units: participant]
 		     
Hispanic or Latino     39     15     54  
Not Hispanic or Latino     201     45     246  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: 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  
[units: participants]
 		     
United States     240     60     300  



  Outcome Measures
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1.  Primary:   Number of Subjects Reporting Fever   [ Time Frame: Days 0-7 ]
  Show Outcome Measure 1

2.  Secondary:   Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-7   [ Time Frame: Days 0-7 ]
  Show Outcome Measure 2

3.  Secondary:   Number of Subjects Reporting Any Adverse Event (AE) Post-treatment   [ Time Frame: Days 0-7 ]
  Show Outcome Measure 3

4.  Secondary:   Number of Subjects Reporting All Solicited Symptoms Post-treatment Days 0-14   [ Time Frame: Days 0-14 ]
  Show Outcome Measure 4

5.  Secondary:   Number of Subjects Reporting Any AEs Post Treatment   [ Time Frame: Days 0-14 ]
  Show Outcome Measure 5

6.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC)   [ Time Frame: Days 0-28 ]
  Show Outcome Measure 6

7.  Secondary:   Number of Subjects Reporting SAEs and SNMCs   [ Time Frame: Days 0-180 ]
  Hide Outcome Measure 7

Measure Type Secondary
Measure Title Number of Subjects Reporting SAEs and SNMCs
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects who received any study vaccine and experienced any follow-up for safety were considered evaluable for safety.

Reporting Groups
  Description
Trivalent Influenza Virus Vaccine 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 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.

Measured Values
    Trivalent Influenza Virus Vaccine     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  240     60  
Number of Subjects Reporting SAEs and SNMCs  
[units: participants]
 		   
Total subjects reporting > 1 SAE     3     1  
Total subjects reporting > 1 SNMC     0     1  

No statistical analysis provided for Number of Subjects Reporting SAEs and SNMCs




  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Raburn Mallory, MD/ Sr Dir Clinical Development
Organization: MedImmune LLC, an affiliate of AstraZeneca
phone: 301-398-0000
e-mail: malloryr@medimmune.com


No publications provided


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
Study First Received: May 13, 2008
Results First Received: August 20, 2010
Last Updated: October 12, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board