ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Shedding and Safety of Trivalent Influenza Virus Vaccine Live, Intranasal in Infants and Young Children

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: NCT00344305
Recruitment Status : Completed
First Posted : June 26, 2006
Results First Posted : November 1, 2010
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Healthy
Intervention: Biological: Trivalent influenza virus vaccine live, intranasal

  Participant Flow

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 200 participants were enrolled in the study from 15-May-2006 through 22-Jun-2006 at 16 sites in the United States of America.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 200 participants were stratified on the basis of their age into two cohorts: Cohort 1 (participants aged between 6 to less than [<] 24 months) and Cohort 2 (participants aged between 24 to < 60 months).

Reporting Groups
  Description
Cohort 1: Participants Between 6 to < 24 Months Age Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
Cohort 2: Participants Between 24 to < 60 Months Age Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).

Participant Flow:   Overall Study
    Cohort 1: Participants Between 6 to < 24 Months Age   Cohort 2: Participants Between 24 to < 60 Months Age
STARTED   100   100 
COMPLETED   98   99 
NOT COMPLETED   2   1 
Lost to Follow-up                2                0 
Participant was not contacted in window                0                1 



  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
Cohort 1: Participants Between 6 to < 24 Months Age Participants received a single, intranasal dose of 0.2 millilitre (mL) (approximately 0.1 mL in each nostril FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 fluorescent focus units (FFU) of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
Cohort 2: Participants Between 24 to < 60 Months Age Participants received a single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains namely, A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2) (A/Fujian/411/2002-like) and B/Jilin/20/2003 (B/Shanghai/361/2002-like).
Total Total of all reporting groups

Baseline Measures
   Cohort 1: Participants Between 6 to < 24 Months Age   Cohort 2: Participants Between 24 to < 60 Months Age   Total 
Overall Participants Analyzed 
[Units: Participants]
 100   100   200 
Age 
[Units: Months]
Mean (Standard Deviation)
 14.87  (5.50)   41.31  (9.98)   28.09  (15.50) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      51  51.0%      53  53.0%      104  52.0% 
Male      49  49.0%      47  47.0%      96  48.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      7   7.0%      15  15.0%      22  11.0% 
Not Hispanic or Latino      93  93.0%      85  85.0%      178  89.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      1   1.0%      1   0.5% 
Asian      0   0.0%      2   2.0%      2   1.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      14  14.0%      7   7.0%      21  10.5% 
White      86  86.0%      89  89.0%      175  87.5% 
More than one race      0   0.0%      1   1.0%      1   0.5% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
History of laboratory-confirmed influenza illness in previous influenza season 
[Units: Participants]
     
Yes   1   2   3 
No   99   98   197 
History of receiving an influenza vaccine 
[Units: Participants]
     
Yes   43   73   116 
No   57   27   84 


  Outcome Measures

1.  Primary:   Percentage of Participants Who Shed Any Vaccine Virus   [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]

2.  Primary:   Percentage of Participants Who Shed A/H1N1 Vaccine Virus   [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]

3.  Primary:   Percentage of Participants Who Shed A/H3N2 Vaccine Virus   [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]

4.  Primary:   Percentage of Participants Who Shed B Vaccine Virus   [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]

5.  Secondary:   Duration of Any Vaccine Virus Shedding   [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]

6.  Secondary:   Duration of Confirmed A/H1N1 Vaccine Virus Shedding   [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]

7.  Secondary:   Duration of Confirmed A/H3N2 Vaccine Virus Shedding   [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]

8.  Secondary:   Duration of Confirmed B Vaccine Virus Shedding   [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]

9.  Secondary:   Quantitation of Confirmed A/H1N1 Shed Vaccine Virus on Any Day   [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]

10.  Secondary:   Quantitation of Confirmed A/H3N2 Shed Vaccine Virus on Any Day   [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]

11.  Secondary:   Quantitation of Confirmed B Shed Vaccine Virus on Any Day   [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]

12.  Secondary:   Number of Participants With Genotypic and Phenotypic Stability of A/H1N1 Shed Vaccine Virus   [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]

13.  Secondary:   Number of Participants With Genotypic and Phenotypic Stability of A/H3N2 Shed Vaccine Virus   [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]

14.  Secondary:   Number of Participants With Genotypic and Phenotypic Stability of B Shed Vaccine Virus   [ Time Frame: Days 1-28 after study vaccination (up to Day 28) ]

15.  Secondary:   Number of Participants With Reactogenicity Events (REs) and Adverse Events (AEs) Through 28 Days Post Vaccination   [ Time Frame: Days 0-28 after vaccination (up to Day 28) ]

16.  Secondary:   Number of Participants With Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMC) Through 180 Days Post Vaccination   [ Time Frame: Days 0-180 after vaccination (up to 6.5 months) ]

17.  Secondary:   Number of Participants With REs in Relation to Any Vaccine Virus Shedding   [ Time Frame: Days 0-28 after study vaccination (up to Day 28) ]


  Serious Adverse Events


  Other Adverse Events


  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

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: Raburn Mallory MD/ Sr Dir Clinical Development
Organization: MedImmune, LLC
phone: 301-398-0000
e-mail: clinicaltrialenquiries@medimmune.com


Publications of Results:

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00344305     History of Changes
Other Study ID Numbers: MI-CP129
First Submitted: June 22, 2006
First Posted: June 26, 2006
Results First Submitted: July 29, 2010
Results First Posted: November 1, 2010
Last Update Posted: July 24, 2017