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Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Healthy Adults

This study has been completed.
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01776541
First received: January 20, 2013
Last updated: January 20, 2015
Last verified: January 2015
Results First Received: January 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Pandemic H5N1 Influenza
Intervention: Biological: Adjuvanted H5N1 pandemic influenza vaccine

  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
Subjects were enrolled at 4 centers in the US, 3 centers in Australia and 1 center in Thailand.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrolled subjects were included in the trial.

Reporting Groups
  Description
High Dose Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
Low Dose Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.

Participant Flow:   Overall Study
    High Dose   Low Dose
STARTED   488   491 
COMPLETED   432   416 
NOT COMPLETED   56   75 
Administrative Reason                6                2 
Death                4                0 
Lost to Follow-up                27                48 
Unclassified                5                4 
Protocol Violation                2                1 
Withdrawal by Subject                12                20 



  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.
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Reporting Groups
  Description
High Dose Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
Low Dose Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
Total Total of all reporting groups

Baseline Measures
   High Dose   Low Dose   Total 
Overall Participants Analyzed 
[Units: Participants]
 488   491   979 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.0  (13.7)   38.4  (14.2)   38.7  (14.0) 
Gender 
[Units: Participants]
     
Female   285   259   544 
Male   203   232   435 


  Outcome Measures
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1.  Primary:   Percentages Of Subjects Achieving Hemagglutinin Inhibition (HI) Titers ≥40 Against A/H5N1 Strain.   [ Time Frame: Three weeks after 2nd vaccination (day 43) ]

2.  Primary:   Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.   [ Time Frame: Three weeks after 2nd vaccination (day 43) ]

3.  Primary:   Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination.   [ Time Frame: From day 1 through day 7 after any vaccination. ]

4.  Primary:   Number of Subjects Reporting Unsolicited AEs After Any Vaccination.   [ Time Frame: Any unsolicited AEs - day 1 through day 22 after any vaccination. SAEs, NOCDs. medically attended AEs, AESIs, AEs leading to study withdrawal- day 1 to day 387 ]

5.  Secondary:   Geometric Mean Ratios Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine.   [ Time Frame: Day 1; day 22; day 43 and day 387 ]

6.  Secondary:   Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain.   [ Time Frame: Day 1, day 22, day 43 and day 387 ]

7.  Secondary:   Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.   [ Time Frame: Day 22, day 43 and day 387 ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
e-mail: RegistryContactVaccinesUS@novartis.com



Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01776541     History of Changes
Other Study ID Numbers: V89_04
Study First Received: January 20, 2013
Results First Received: January 20, 2015
Last Updated: January 20, 2015
Health Authority: United States: Food and Drug Administration
Thailand: Food and Drug Administration
Australia: Therapeutic Goods Administration