A Study to Evaluate the Safety of HIN1 Monovalent Vaccine (MEDI3414) in Children 2 to 17 Years of Age (MI-CP217)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00946101
First received: July 23, 2009
Last updated: July 15, 2011
Last verified: July 2011
Results First Received: June 9, 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: MEDI3414 [Influenza A(H1N1) live attenuated, intranasal]
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
Study participation began once written informed consent was obtained. The first and last dates of informed consent were 03 Aug 2009 and 19 Aug 2009. Once informed consent was obtained, a subject identification number was assigned using an interactive voice response system, and screening evaluations began to assess study eligibility.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible subjects were randomly assigned in a 4:1 ratio to receive 2 doses of study monovalent vaccine or placebo by intranasal spray; the doses were administered approximately 28 days apart, on Days 1 and 29.

Reporting Groups
  Description
H1N1 Monovalent Influenza Vaccine MEDI3414- Monovalent vaccine 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 influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.

Participant Flow:   Overall Study
    H1N1 Monovalent Influenza Vaccine     Placebo  
STARTED     261 [1]   65  
Day 15 Post Dose 1     260     64  
Day 15 Post Dose 2     254     63  
COMPLETED     257     63  
NOT COMPLETED     4     2  
Lost to Follow-up                 2                 1  
Withdrawal of consent                 2                 0  
Physician Decision                 0                 1  
[1] Intent to Treat population, enrolled and randomized



  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
H1N1 Monovalent Influenza Vaccine MEDI3414- Monovalent vaccine 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 influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Placebo Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
Total Total of all reporting groups

Baseline Measures
    H1N1 Monovalent Influenza Vaccine     Placebo     Total  
Number of Participants  
[units: participants]
  261     65     326  
Age  
[units: years]
Mean ± Standard Deviation
  8.9  ± 4.3     9.2  ± 4.3     9.0  ± 4.3  
Gender  
[units: participants]
     
Female     130     36     166  
Male     131     29     160  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     50     17     67  
Not Hispanic or Latino     211     48     259  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     4     0     4  
Asian     2     4     6  
Native Hawaiian or Other Pacific Islander     2     0     2  
Black or African American     43     12     55  
White     198     43     241  
More than one race     8     1     9  
Unknown or Not Reported     0     0     0  
Other     4     5     9  



  Outcome Measures
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1.  Primary:   Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Axillary Temperature ≥ 101°F (38.3°C).   [ Time Frame: Days 1- 8 ]

2.  Primary:   Number of Participants Who Experience a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus   [ Time Frame: Day 1, Day 15 ]

3.  Primary:   Number of Participants Who Experience a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus   [ Time Frame: Day 1, Day 29 ]

4.  Primary:   Number of Participants Who Experience a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus   [ Time Frame: Day 1, Day 57 ]

5.  Secondary:   Number of Participants With Any Solicited Symptoms Within 7 Days After Vaccination With Investigational Product, Dose 1   [ Time Frame: Days 1-8 ]

6.  Secondary:   Number of Participants Reporting Adverse Events (AEs) Within 7 Days After Vaccination With Investigational Product, Dose 1   [ Time Frame: Days 1-8 ]

7.  Secondary:   Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days After Vaccination With Investigational Product, Dose 1   [ Time Frame: Days 1-8 ]

8.  Secondary:   Number of Participants With Any Solicited Symptoms Within 14 Days After Vaccination With Investigational Product, Dose 1   [ Time Frame: Days 1-15 ]

9.  Secondary:   Number of Participants Reporting AEs Within 14 Days After Vaccination With Investigational Product, Dose 1   [ Time Frame: Days 1-15 ]

10.  Secondary:   Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days After Vaccination With Investigational Product, Dose 1   [ Time Frame: Days 1-15 ]

11.  Secondary:   Number of Participants With Any Solicited Symptoms Within 7 Days After Vaccination With Investigational Product, Dose 2   [ Time Frame: Days 29-36 ]

12.  Secondary:   Number of Participants Reporting AEs Within 7 Days After Vaccination With Investigational Product, Dose 2   [ Time Frame: Days 29-36 ]

13.  Secondary:   Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days After Vaccination With Investigational Product, Dose 2   [ Time Frame: Days 29-36 ]

14.  Secondary:   Number of Participants With Any Solicited Symptoms Within 14 Days After Vaccination With Investigational Product, Dose 2   [ Time Frame: Days 29-43 ]

15.  Secondary:   Number of Participants Reporting AEs Within 14 Days After Vaccination With Investigational Product, Dose 2   [ Time Frame: Days 29-43 ]

16.  Secondary:   Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days After Vaccination With Investigational Product, Dose 2   [ Time Frame: Days 29-43 ]

17.  Secondary:   Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days After Vaccination With Investigational Product, Dose 1.   [ Time Frame: Days 1-29 ]

18.  Secondary:   Number of Participants With Serious Adverse Events (SAEs) Within 28 Days After Vaccination With Investigational Product, Dose 1   [ Time Frame: Days 1-29 ]

19.  Secondary:   Number of Participants With NOCDs Within 28 Days After Vaccination With Investigational Product, Dose 2.   [ Time Frame: Days 29-57 ]

20.  Secondary:   Number of Participants With SAEs Within 28 Days After Vaccination With Investigational Product, Dose 2   [ Time Frame: Days 29-57 ]

21.  Secondary:   Number of Participants With NOCDs Within 180 Days Post Final Dose of Investigational Product.   [ Time Frame: Days 1-209 ]

22.  Secondary:   Number of Participants With SAEs Within 180 Days Post Final Dose of Investigational Product.   [ Time Frame: Days 1-209 ]

23.  Secondary:   Number of Participants Who Achieve a Post Dose 1 (Day 15) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.   [ Time Frame: Day 1, Day 15 ]

24.  Secondary:   Number of Participants Who Achieve a Post Dose 1 (Day 29) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.   [ Time Frame: Day 1, Day 29 ]

25.  Secondary:   Number of Participants Who Achieve a Post Dose 2 (Day 57) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.   [ Time Frame: Day 1, Day 57 ]

26.  Secondary:   Serum HAI Geometric Mean Titers (GMTs) in All Participants, Regardless of Baseline Serostatus, Dose 1 (Day 15)   [ Time Frame: Day 1, Day 15 ]

27.  Secondary:   Serum HAI GMTs in All Participants, Regardless of Baseline Serostatus, Dose 1 (Day 29)   [ Time Frame: Day 1, Day 29 ]

28.  Secondary:   Serum HAI GMTs in All Participants, Regardless of Baseline Serostatus, Dose 2 (Day 57)   [ Time Frame: Day 1, Day 57 ]


  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: Elissa Malkin, D.O.
Organization: MedImmune, LLC an affiliate of AstraZeneca AB
phone: 301-398-0000
e-mail: malkine@medimmune.com


No publications provided by MedImmune LLC

Publications automatically indexed to this study:

Responsible Party: Elissa Malkin, D.O., MedImmune LLC
ClinicalTrials.gov Identifier: NCT00946101     History of Changes
Other Study ID Numbers: MI-CP217, HHS/ASPR
Study First Received: July 23, 2009
Results First Received: June 9, 2010
Last Updated: July 15, 2011
Health Authority: United States: Food and Drug Administration