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Higher Dose Intradermal H5 Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00439335
First received: February 22, 2007
Last updated: March 28, 2013
Last verified: August 2009
Results First Received: March 24, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: Inactivated Influenza A Vaccine A/H5N1
Drug: Placebo (IM)
Drug: Placebo (ID)

  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
Healthy ambulatory adults were recruited from the surrounding community of the research clinic from March 14, 2007 to June 20, 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
H5 HA ID Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
H5 HA IM Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.

Participant Flow:   Overall Study
    H5 HA ID     H5 HA IM  
STARTED     113     114  
COMPLETED     111     114  
NOT COMPLETED     2     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
H5 HA ID Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
H5 HA IM Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
Total Total of all reporting groups

Baseline Measures
    H5 HA ID     H5 HA IM     Total  
Number of Participants  
[units: participants]
  113     114     227  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     113     114     227  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  29.7  ± 7.4     30.5  ± 8.0     30.1  ± 7.7  
Gender  
[units: participants]
     
Female     74     60     134  
Male     39     54     93  
Region of Enrollment  
[units: participants]
     
United States     113     114     227  



  Outcome Measures
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1.  Primary:   Number of Participants Achieving a 4-fold or Greater Increase in HAI Antibody Titers After Dose 2   [ Time Frame: Approximately Day 56. ]

2.  Primary:   Number of Participants Spontaneously Reporting Any Serious Adverse Event.   [ Time Frame: Through Day 208. ]

3.  Primary:   Occurrence of Unsolicited Symptoms During a 28-day Surveillance Period Following Vaccinations at Days 0 and 28.   [ Time Frame: Through approximately Day 56 ]

4.  Primary:   Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28.   [ Time Frame: 7 days after each vaccination ]

5.  Primary:   Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0 and 28.   [ Time Frame: 7 days after each vaccination ]

6.  Secondary:   HAI Geometric Mean Titer (GMT) After Dose 2   [ Time Frame: Approximately Day 56. ]

7.  Secondary:   Number of Participants Achieving a HAI Titer of Greater Than or Equal to 40 After Dose 2   [ Time Frame: Approximately Day 56 ]

8.  Secondary:   Number of Participants Achieving a 4-fold or Greater Increase in HAI Antibody Titers After Dose 1.   [ Time Frame: Approximately Day 28 ]

9.  Secondary:   HAI GMT After Dose 1   [ Time Frame: Approximately Day 28 ]

10.  Secondary:   Number of Participants Achieving a Serum HAI Titer of Greater Than or Equal to 40 After Dose 1.   [ Time Frame: Approximately Day 28 ]

11.  Secondary:   Number of Participants Achieving a 4-fold or Greater Increase in HAI Antibody Titers 7 Months After Dose 1.   [ Time Frame: Approximately Day 208 ]

12.  Secondary:   HAI GMT at 7 Months After Dose 1   [ Time Frame: Approximately Day 208 ]

13.  Secondary:   Number of Participants Achieving a Serum HAI Titer of Greater Than or Equal to 40 at 7 Months After Dose 1.   [ Time Frame: Approximately Day 208 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Shital Patel, MD
Organization: Baylor College of Medicine
phone: 713-798-3793
e-mail: shitalp@bcm.tmc.edu


Publications of Results:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00439335     History of Changes
Other Study ID Numbers: 06-0089
Study First Received: February 22, 2007
Results First Received: March 24, 2009
Last Updated: March 28, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Food and Drug Administration