A Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca, PLC
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01579916
First received: April 16, 2012
Last updated: December 16, 2013
Last verified: December 2013
Results First Received: December 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: Trivalent Influenza Virus Vaccine
Other: 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
303 participants participated in the study from 21May2012 (date of first written informed consent) through 30Nov2012 (date of last participant visit).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Trivalent Influenza Virus Vaccine     Placebo  
STARTED     242     61  
COMPLETED     234     59  
NOT COMPLETED     8     2  
Lost to Follow-up                 6                 1  
Withdrawal by Subject                 1                 1  
Death                 1                 0  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
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.
TOTAL Total of all reporting groups

Baseline Measures
    Trivalent Influenza Virus Vaccine     Placebo     TOTAL  
Number of Participants  
[units: participants]
  242     61     303  
Age  
[units: Years]
Mean ± Standard Deviation
  32.7  ± 9.1     32.0  ± 8.8     32.6  ± 9.0  
Gender  
[units: Participants]
     
Female     136     29     165  
Male     106     32     138  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Reporting Fever Within 7 Days Post Vaccination   [ Time Frame: Study Days 1 - 8 ]

2.  Secondary:   Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination   [ Time Frame: Study Days 1- 8 ]

3.  Secondary:   Percentage of Participants Reporting Any Adverse Event (AE) Within 7 Days Post Vaccination   [ Time Frame: Study Days 1 - 8 ]

4.  Secondary:   Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination   [ Time Frame: Study Days 1 - 15 ]

5.  Secondary:   Percentage of Participants Reporting Any Adverse Event (AE) Within 14 Days Post Vaccination   [ Time Frame: Study Days 1 - 15 ]

6.  Secondary:   Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 28 Days Post Vaccination   [ Time Frame: Study Days 1 - 29 ]

7.  Secondary:   Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 180 Days Post Vaccination   [ Time Frame: Study Days 1 - 181 ]

8.  Secondary:   Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination   [ Time Frame: Study Days 1 - 29 ]

9.  Secondary:   Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 180 Days Post Vaccination   [ Time Frame: Study Days 1 - 181 ]

10.  Secondary:   Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 7 Days Post Vaccination   [ Time Frame: Study Days 1 - 8 ]

11.  Secondary:   Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 14 Days Post Vaccination   [ Time Frame: Study Days 1 - 15 ]


  Serious Adverse Events


  Other Adverse Events


  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/Senior Director Clinical Development
Organization: MedImmune, LLC
phone: 301-398-0000
e-mail: malloryr@medimmune.com


No publications provided


Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01579916     History of Changes
Other Study ID Numbers: CD-VA-FluMist-1114
Study First Received: April 16, 2012
Results First Received: December 16, 2013
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration