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Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects

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ClinicalTrials.gov Identifier: NCT00481065
Recruitment Status : Completed
First Posted : June 1, 2007
Results First Posted : February 28, 2013
Last Update Posted : February 3, 2014
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Pandemic
Avian Influenza
Interventions: Biological: MF59-eH5N1
Biological: eTIV_a
Biological: MF59-eH5N1 + eTIV_a

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at 1 center in Colombia.

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. A total of 405 subjects was enrolled and randomized into 8 groups in this study. The participant flow data are from the all randomized set.

Reporting Groups
  Description
Concomitant Alone 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Concomitant+Mixed 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Concomitant+MF59-eH5N1 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Mixed 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Mixed + Mixed dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
Mixed+MF59-eH5N1 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
MF59-eH5N1+eTIV_a 1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
eTIV_a+MF59-eH5N1 1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

Participant Flow:   Overall Study
    Concomitant Alone   Concomitant+Mixed   Concomitant+MF59-eH5N1   Mixed   Mixed + Mixed   Mixed+MF59-eH5N1   MF59-eH5N1+eTIV_a   eTIV_a+MF59-eH5N1
STARTED   51   50   51   52   51   51   50   49 
COMPLETED   29   33   32   37   28   27   34   30 
NOT COMPLETED   22   17   19   15   23   24   16   19 
Adverse event or death                1                1                3                0                2                0                1                1 
Withdrawal by Subject                11                12                7                11                13                12                9                10 
Lost to Follow-up                4                2                4                3                3                3                2                5 
Inappropriate enrollment                4                0                2                0                2                1                0                1 
Administrative reason                0                0                0                0                0                2                1                0 
Protocol Violation                2                1                1                1                2                6                3                2 
Unable to classify                0                1                2                0                1                0                0                0 



  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.
The demographic characteristics of the randomized population are summarized in this section.

Reporting Groups
  Description
Concomitant Alone 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Concomitant+Mixed 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Concomitant+MF59-eH5N1 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Mixed 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Mixed + Mixed dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
Mixed+MF59-eH5N1 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
MF59-eH5N1+eTIV_a 1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
eTIV_a+MF59-eH5N1 1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Total Total of all reporting groups

Baseline Measures
   Concomitant Alone   Concomitant+Mixed   Concomitant+MF59-eH5N1   Mixed   Mixed + Mixed   Mixed+MF59-eH5N1   MF59-eH5N1+eTIV_a   eTIV_a+MF59-eH5N1   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 51   50   51   52   51   51   50   49   405 
Age 
[Units: Years]
Mean (Standard Deviation) 		 29  (6.2)   29.4  (5.8)   29.5  (6.5)   29.8  (6.8)   29.6  (6.1)   28.8  (6.2)   27.9  (6.2)   30.1  (6.2)   29.3  (6.2) 
Gender 
[Units: Participants]
 		                 
Female   42   31   36   30   36   39   30   32   276 
Male   9   19   15   22   15   12   20   17   129 


  Outcome Measures

1.  Primary:   Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine   [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ]
  Show Outcome Measure 1

2.  Primary:   Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine   [ Time Frame: 21 days after second and third vaccinations (day 22 and day 43) ]
  Show Outcome Measure 2

3.  Primary:   Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)   [ Time Frame: 21 days after second vaccination (day 43) ]
  Show Outcome Measure 3

4.  Primary:   Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)   [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ]
  Show Outcome Measure 4

5.  Primary:   Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)   [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ]
  Show Outcome Measure 5

6.  Primary:   Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1)   [ Time Frame: 21 days after second vaccination (day 43) ]
  Show Outcome Measure 6

7.  Primary:   Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)   [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ]
  Show Outcome Measure 7

8.  Primary:   Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)   [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ]
  Show Outcome Measure 8

9.  Secondary:   Number of Subjects Reporting Local and Systemic Reactions by Vaccination   [ Time Frame: 21 days after second and third vaccinations (day 43 and day 403) ]
  Show Outcome Measure 9

10.  Secondary:   Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine   [ Time Frame: 21 days after booster vaccination (day 403) ]
  Show Outcome Measure 10

11.  Secondary:   Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine   [ Time Frame: 21 days after booster vaccination (day 403) ]
  Show Outcome Measure 11


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


Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00481065     History of Changes
Other Study ID Numbers: V87P5
First Submitted: May 31, 2007
First Posted: June 1, 2007
Results First Submitted: August 26, 2011
Results First Posted: February 28, 2013
Last Update Posted: February 3, 2014