Second Extension Study to Evaluate Safety and Tolerability of Influenza Vaccines in Adults and Elderly, and to Evaluate Immunogenicity and Concomitant Vaccination With Pneumococcal Vaccine in a Subgroup

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00579345
First received: December 19, 2007
Last updated: October 24, 2012
Last verified: October 2012
Results First Received: September 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: Cell culture derived seasonal trivalent influenza vaccine (cTIV)
Biological: Influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a).
Biological: cTIV or eTIV_a
Biological: cTIV+PV OR eTIV_a+PV

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study was conducted during the period of October 2007 to June 2008 at five sites in Poland.

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. The data entered is for overall study

Reporting Groups
  Description
cTIV (Adults) Revaccination unrandomized group (adult subjects who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
eTIV_a (Adults) Revaccination unrandomized group (adult subjects who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine[egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
cTIV (Elderly) Revaccination unrandomized group (elderly subjects who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
eTIV_a (Elderly) Revaccination unrandomized group (elderly subjects who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) study with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
cTIV (Elderly; FLU Vaccination) Revaccination randomized group (elderly subjects were revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study.
cTIV+PV (Elderly; Concomitant Vaccination ) Revaccination randomized group (elderly subjects were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV; in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
eTIV_a (Elderly; FLU Vaccination) Revaccination randomized group (elderly subjects were revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
eTIV_a +PV (Elderly; Concomitant Vaccination) Revaccination randomized group (elderly subjects were concomitantly revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).

Participant Flow:   Overall Study
    cTIV (Adults)     eTIV_a (Adults)     cTIV (Elderly)     eTIV_a (Elderly)     cTIV (Elderly; FLU Vaccination)     cTIV+PV (Elderly; Concomitant Vaccination )     eTIV_a (Elderly; FLU Vaccination)     eTIV_a +PV (Elderly; Concomitant Vaccination)  
STARTED     549     169     391     144     90     78     57     44  
COMPLETED     544     168     389     143     90     78     57     42  
NOT COMPLETED     5     1     2     1     0     0     0     2  
Withdrawal by Subject                 2                 0                 0                 0                 0                 0                 0                 1  
Lost to Follow-up                 1                 0                 0                 0                 0                 0                 0                 0  
Adverse Event                 0                 0                 1                 0                 0                 0                 0                 0  
Protocol Violation                 1                 0                 0                 0                 0                 0                 0                 1  
Death                 1                 1                 1                 1                 0                 0                 0                 0  



  Baseline Characteristics
  Hide 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.
No text entered.

Reporting Groups
  Description
cTIV (Adults) Revaccination unrandomized group (adult subjects who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
eTIV_a (Adults) Revaccination unrandomized group (adult subjects who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine[egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
cTIV (Elderly) Revaccination unrandomized group (elderly subjects who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
eTIV_a (Elderly) Revaccination unrandomized group (elderly subjects who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) study with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
cTIV (Elderly; FLU Vaccination) Revaccination randomized group (elderly subjects were revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study.
cTIV+PV (Elderly; Concomitant Vaccination ) Revaccination randomized group (elderly subjects were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV; in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
eTIV_a (Elderly; FLU Vaccination) Revaccination randomized group (elderly subjects were revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
eTIV_a +PV (Elderly; Concomitant Vaccination) Revaccination randomized group (elderly subjects were concomitantly revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
Total Total of all reporting groups

Baseline Measures
    cTIV (Adults)     eTIV_a (Adults)     cTIV (Elderly)     eTIV_a (Elderly)     cTIV (Elderly; FLU Vaccination)     cTIV+PV (Elderly; Concomitant Vaccination )     eTIV_a (Elderly; FLU Vaccination)     eTIV_a +PV (Elderly; Concomitant Vaccination)     Total  
Number of Participants  
[units: participants]
  549     169     391     144     90     78     57     44     1522  
Age  
[units: years]
Mean ± Standard Deviation
                 
Unrandomized adults     44  ± 12.3     43.3  ± 12.4     NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   43.9  ± 12.3  
Unrandomized elderly     NA  ± NA [2]   NA  ± NA [2]   71.5  ± 5.5     72.4  ± 5.7     NA  ± NA [2]   NA  ± NA [2]   NA  ± NA [2]   NA  ± NA [2]   71.7  ± 5.6  
Randomized elderly     NA  ± NA [3]   NA  ± NA [3]   NA  ± NA [3]   NA  ± NA [3]   71.6  ± 5.9     71.5  ± 5.5     71.2  ± 4.9     71.1  ± 5.2     71.4  ± 5.5  
Gender  
[units: participants]
                 
Female     318     102     232     90     46     40     38     25     891  
Male     231     67     159     54     44     38     19     19     631  
[1] This category does not belong to unrandomized adults
[2] This category does not belong to unrandomized elderly
[3] This category does not belong to randomized elderly



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Randomized Participants Reporting Local and Systemic Reactions   [ Time Frame: One week postvaccination ]

2.  Primary:   Immunogenicity Assessment by Geometric Mean Titers (GMT)   [ Time Frame: Three weeks postvaccination ]

3.  Secondary:   Number of Unrandomized Participants Reporting Local and Systemic Reactions   [ Time Frame: One week postvaccination ]

4.  Secondary:   Number of Randomized Participants Reporting Local and Systemic Reactions.   [ Time Frame: One week postvaccination ]

5.  Secondary:   Number of Subjects With Antibody Response as Assessed by Hemagglutination Inhibition Assay   [ Time Frame: Three weeks postvaccination ]

6.  Secondary:   Geometric Mean Ratio (GMR Day 22/Day1) After Single Dose of Influenza Vaccine   [ Time Frame: Three weeks postvaccination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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


No publications provided by Novartis

Publications automatically indexed to this study:

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00579345     History of Changes
Other Study ID Numbers: V58P4E2, 2006-003077-27
Study First Received: December 19, 2007
Results First Received: September 5, 2011
Last Updated: October 24, 2012
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products