A Study to Evaluate the Immunogenicity of Quadrivalent LAIV (MEDI8662) in Adults 18 to 49 Years of Age (MI-CP206)

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00952705
First received: August 3, 2009
Last updated: December 9, 2011
Last verified: December 2011
Results First Received: June 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Healthy or Stable Underlying Chronic Medical Condition
Interventions: Biological: Q/LAIV-BFS (MEDI8662)
Biological: FluMist/B/Yamagata
Biological: FluMist/B/Victoria

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were screened for the study within 30 days prior to randomization at investigator clinic sites in the USA. The first and last dates of informed consent were 14Aug2009 and 26Aug2009, respectively.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 1,888 participants who provided written informed consent and were screened for the study, 88 were screened but were not randomized into the study due to one or more of the following reasons: not meeting the eligibility criteria; study was full; withdrawal of consent; lost to follow-up; unable to obtain a blood sample for immunogenicity testing.

Reporting Groups
  Description
Q/LAIV-BFS (MEDI8662) Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
FluMist/B/Yamagata FluMist/B/Yamagata was administered intranasally using a Becton Dickinson (BD) Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
FluMist/B/Victoria FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).

Participant Flow:   Overall Study
    Q/LAIV-BFS (MEDI8662)     FluMist/B/Yamagata     FluMist/B/Victoria  
STARTED     1202 [1]   300     298  
COMPLETED     1169     290     288  
NOT COMPLETED     33     10     10  
Lost to Follow-up                 24                 8                 9  
Withdrawal by Subject                 2                 1                 1  
Death                 2                 0                 0  
Incarcerated post dose                 5                 0                 0  
Exclusion criteria not met pre dose                 0                 1                 0  
[1] Three not treated with Q/LAIV-BFS (1 treated with FluMist/B/Yamagata; 2 withdrew prior to dosing).



  Baseline Characteristics
  Hide Baseline Characteristics

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
Q/LAIV-BFS (MEDI8662) Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
FluMist/B/Yamagata FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
FluMist/B/Victoria FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
Total Total of all reporting groups

Baseline Measures
    Q/LAIV-BFS (MEDI8662)     FluMist/B/Yamagata     FluMist/B/Victoria     Total  
Number of Participants  
[units: participants]
  1202     300     298     1800  
Age  
[units: Years]
Mean ± Standard Deviation
  33.9  ± 9.5     34.0  ± 9.1     33.8  ± 8.8     33.9  ± 9.3  
Gender  
[units: Participants]
       
Female     701     169     167     1037  
Male     501     131     131     763  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Post Dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMTs) in the Q/LAIV-BFS (MEDI8662) Arm as Compared to Those in the Combined Flumist Arms (All Flumist Group).   [ Time Frame: Day 28 to 35 ]

2.  Secondary:   The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus.   [ Time Frame: Day 0 and Day 28-35 ]

3.  Secondary:   The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus.   [ Time Frame: Day 0 and Day 28-35 ]

4.  Secondary:   The Percentage of Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus.   [ Time Frame: Day 0 and Day 28-35 ]

5.  Secondary:   The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain.   [ Time Frame: Day 0 and Day 28-35 ]

6.  Secondary:   The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain.   [ Time Frame: Day 0 and Day 28-35 ]

7.  Secondary:   The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain.   [ Time Frame: Day 0 and Day 28-35 ]

8.  Secondary:   The Percentage of Serosusceptible Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain.   [ Time Frame: Day 0 and Day 28-35 ]

9.  Secondary:   The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H1N1 Strain.   [ Time Frame: Day 0 and Day 28-35 ]

10.  Secondary:   The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the A/H3N2 Strain.   [ Time Frame: Day 0 and Day 28-35 ]

11.  Secondary:   The Percentage of Seropositive Participants Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Yamagata Strain.   [ Time Frame: Day 0 and Day 28-35 ]

12.  Secondary:   The Percentage of Seropositive Subjects Experiencing Post Dose Strain-specific HAI Antibody Seroresponse to the B/Victoria Strain.   [ Time Frame: Day 0 and Day 28-35 ]

13.  Secondary:   The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 and A/H3N2 Strains in All Participants, Regardless of Baseline Serostatus.   [ Time Frame: Day 28-35 ]

14.  Secondary:   The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain in All Participants, Regardless of Baseline Serostatus.   [ Time Frame: Day 28-35 ]

15.  Secondary:   The Percentage of Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain in All Participants, Regardless of Baseline Serostatus.   [ Time Frame: Day 28-35 ]

16.  Secondary:   The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain.   [ Time Frame: Day 28-35 ]

17.  Secondary:   The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain.   [ Time Frame: Day 28-35 ]

18.  Secondary:   The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain.   [ Time Frame: Day 28-35 ]

19.  Secondary:   The Percentage of Serosusceptible Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain.   [ Time Frame: Day 28-35 ]

20.  Secondary:   The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H1N1 Strain.   [ Time Frame: Day 28-35 ]

21.  Secondary:   The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the A/H3N2 Strain.   [ Time Frame: Day 28-35 ]

22.  Secondary:   The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Yamagata Strain.   [ Time Frame: Day 28-35 ]

23.  Secondary:   The Percentage of Seropositive Participants Achieving a Post Dose Strain-specific HAI Antibody Titer ≥ 32 to the B/Victoria Strain.   [ Time Frame: Day 28-35 ]

24.  Secondary:   The Percentage of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Dose   [ Time Frame: Days 0-14 post dose ]

25.  Secondary:   The Percentage of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Dose   [ Time Frame: Days 0-28 post dose ]

26.  Secondary:   The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Dose   [ Time Frame: Days 0-28 post dose ]

27.  Secondary:   The Percentage of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Dose   [ Time Frame: Days 0-180 post dose ]

28.  Secondary:   The Percentage of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Dose   [ Time Frame: Days 0-180 post dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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.


Results Point of Contact:  
Name/Title: JA Sliman, MD, MPH, Director, Clinical Development
Organization: MedImmune, LLC
phone: 301-398-0000
e-mail: SlimanJ@medimmune.com


No publications provided


Responsible Party: J. A. Sliman, MD, MPH, MedImmune, LLC
ClinicalTrials.gov Identifier: NCT00952705     History of Changes
Other Study ID Numbers: MI-CP206
Study First Received: August 3, 2009
Results First Received: June 28, 2011
Last Updated: December 9, 2011
Health Authority: United States: Food and Drug Administration