Safety, Tolerability and Immunogenicity of Two Doses of Adjuvanted Monovalent Influenza Vaccine Administered to Healthy Adult and Elderly Subjects

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00841763
First received: February 10, 2009
Last updated: January 18, 2013
Last verified: January 2013
Results First Received: July 4, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Pandemic Influenza Disease
Interventions: Biological: Placebo
Biological: Trivalent influenza virus vaccine (TIV)
Biological: Adjuvanted monovalent influenza virus vaccine (aH5N1)
Biological: Adjuvanted trivalent influenza vaccine (aTIV)

  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 from 27 centers across Finland and Germany

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

Reporting Groups
  Description
TIV + aH5N1 (18 to 60 Yrs) First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
PL+ aTIV (18 to 60 Yrs) First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
TIV + aH5N1 (>60 Yrs) First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
PL + aTIV (>60 Yrs) First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)

Participant Flow:   Overall Study
    TIV + aH5N1 (18 to 60 Yrs)     PL+ aTIV (18 to 60 Yrs)     TIV + aH5N1 (>60 Yrs)     PL + aTIV (>60 Yrs)  
STARTED     2691     681     219     56  
COMPLETED     2529     624     211     53  
NOT COMPLETED     162     57     8     3  
Withdrawal by Subject                 60                 17                 4                 1  
Adverse Event                 9                 10                 3                 2  
Lost to Follow-up                 63                 25                 0                 0  
Protocol Violation                 20                 3                 1                 0  
Administrative Reasons                 3                 1                 0                 0  
Unable to Classify                 7                 1                 0                 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
TIV + aH5N1 First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1).
PL+ aTIV First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
Total Total of all reporting groups

Baseline Measures
    TIV + aH5N1     PL+ aTIV     Total  
Number of Participants  
[units: participants]
  2911     735     3646  
Age, Customized [1]
[units: years]
Mean ± Standard Deviation
     
<= 60 years     40.7  ± 11.6     40.5  ± 12.0     40.7  ± 11.7  
>60 years (N=196, 50)     61.9  ± 1.4     62.1  ± 1.8     61.9  ± 1.5  
Gender, Customized  
[units: Subjects]
     
Female (<=60 yrs)     1502     388     1890  
Male(<=60 yrs)     1190     291     1481  
Female (>60 yrs; N= 109; 28)     109     28     137  
Male(>60 yrs; N= 110, 28)     110     28     138  
[1] The number of subjects analyzed is not consistent with the Participant Flow module due to randomization errors. The enrolled set as randomized is reported in the Participant Flow Module but in the Baseline Measure module, the enrolled set as treated is reported (2 randomization errors so 2 subjects were changed from the TIV+aH5N1 group to the PL+aTIV group). Moreover, a subset to the enrolled population as treated excluded the one subject who was not vaccinated.



  Outcome Measures
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1.  Primary:   Number of Participants With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine   [ Time Frame: Up to 7 days after each vaccination ]

2.  Secondary:   The Number of Participants With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine   [ Time Frame: Up to 7 days after each vaccination ]

3.  Secondary:   Geometric Mean Titers After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain   [ Time Frame: 3 weeks after vaccination (day 22, day 43, day 64) ]

4.  Secondary:   Geometric Mean Areas After Two Doses of the Adjuvanted Monovalent Influenza Virus Vaccine (aH5N1)   [ Time Frame: 3 weeks after vaccination (day22, day 43, day 64) ]

5.  Secondary:   Geometric Mean Ratios After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain   [ Time Frame: 3 weeks after vaccination (day 43/day22, day 64/day43) ]

6.  Secondary:   Percentages of Participants Achieving Geometric Mean Titers ≥ 40 and Geometric Mean Areas ≥ 25mm2, After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain)   [ Time Frame: 3 weeks after vaccination (day 22, day 43, day 64) ]

7.  Secondary:   Percentages of Participants Achieving Seroconversion or Significant Increase in Antibody Titer After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain   [ Time Frame: 3 weeks after vaccination (day 43/day22 and day 64/day22) ]

8.  Secondary:   Geometric Mean Titers After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.   [ Time Frame: 3 weeks after vaccination (day 22, day 43, day 64) ]

9.  Secondary:   Geometric Mean Areas After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.   [ Time Frame: 3 weeks after vaccination (day 22, day 43, day 64) ]

10.  Secondary:   Geometric Mean Ratios After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.   [ Time Frame: 3 weeks after vaccination (day 43/day 22 and day 64/day 22) ]

11.  Secondary:   Percentages of Participants Achieving Geometric Mean Titers ≥ 40 and Geometric Mean Areas ≥ 25mm2, After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain   [ Time Frame: 3 weeks after vaccination (day 22, day 43, day 64) ]

12.  Secondary:   Percentages of Participants Achieving Seroconversion or Significant Increase in Antibody Titers, After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.   [ Time Frame: 3 weeks after vaccination (day 43/day 22 and day 64/day 22) ]


  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 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.


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: Posting Director
Organization: Novartis Vaccines and Diagnostics
e-mail: RegistryContactVaccinesUS@novartis.com


Publications of Results:

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00841763     History of Changes
Other Study ID Numbers: V87P13, 2008-003871-32
Study First Received: February 10, 2009
Results First Received: July 4, 2011
Last Updated: January 18, 2013
Health Authority: Germany: Paul-Ehrlich-Institut