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Pediatric Safety and Immunogenicity Study of Cell-Culture Derived and Egg-based Subunit Influenza Vaccines in Healthy Children and Adolescents

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00645411
First received: March 21, 2008
Last updated: January 15, 2013
Last verified: January 2013
Results First Received: November 21, 2012  
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 influenza subunit vaccine (cTIV)
Biological: Egg derived influenza subunit vaccine (eTIV_f)

  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
Participants were enrolled from 14 sites in Finland, 16 in the US, 9 in Croatia, 5 in Italy, 6 in Lithuania, 2 in Romania, 8 in Hungary.

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
Cohort 1 (9-17 Yrs) cTIV All subjects received one 0.5 mL IM injection,of Cell Culture-derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 [H1N1]-like, A/Wisconsin/67/2005 [H3N2]-like,and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere
Cohort 1 (9-17 Yrs) eTIV_f All subjects received one 0.5 mL injection, of egg -derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 [H1N1]-like, A/Wisconsin/67/2005 [H3N2]-like and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere
Cohort 2 (9-17 Yrs) cTIV Same as Cohort 1 cTIV, but these subjects were included only for safety analysis.
Cohort 2 (9-17 Yrs) eTIV_f Same as cohort 1 eTIV_f, but these subjects were included only for safety analysis.
Cohort 3 (3-8 Yrs) cTIV All subjects received two 0.5 mL injections, administered four weeks apart,of Cell Culture-derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 [H1N1]-like, A/Wisconsin/67/2005 [H3N2]-like and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere
Cohort 3 (3-8 Yrs) eTIV_f All subjects received two 0.5 mL injections, administered four weeks apart of egg -derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 [H1N1]-like, A/Wisconsin/67/2005 [H3N2]-like and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere

Participant Flow:   Overall Study
    Cohort 1 (9-17 Yrs) cTIV     Cohort 1 (9-17 Yrs) eTIV_f     Cohort 2 (9-17 Yrs) cTIV     Cohort 2 (9-17 Yrs) eTIV_f     Cohort 3 (3-8 Yrs) cTIV     Cohort 3 (3-8 Yrs) eTIV_f  
STARTED     151     154     505     164     1608     1022  
COMPLETED     145     150     498     162     1457     919  
NOT COMPLETED     6     4     7     2     151     103  
Adverse Event                 0                 0                 0                 0                 0                 2  
Withdrawal by Subject                 1                 1                 1                 0                 19                 21  
Lost to Follow-up                 5                 3                 5                 2                 124                 75  
Protocol Violation                 0                 0                 1                 0                 1                 0  
Inappropriate enrollment                 0                 0                 0                 0                 4                 1  
Unable to classify                 0                 0                 0                 0                 3                 4  



  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
Cohort 1 + 2 (9-17 Yrs) cTIV All subjects received one 0.5 mL IM injection,of Cell Culture-derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 [H1N1]-like, A/Wisconsin/67/2005 [H3N2]-like, and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere
Cohort 1+ 2 (9-17 Yrs) eTIV_f All subjects received one 0.5 mL injection, of egg -derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 [H1N1]-like, A/Wisconsin/67/2005 [H3N2]-like and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere
Cohort 3 (3-8 Yrs) cTIV All subjects received two 0.5 mL injections, administered four weeks apart,of Cell Culture-derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 [H1N1]-like, A/Wisconsin/67/2005 [H3N2]-like and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere
Cohort 3 (3-8 Yrs) eTIV_f All subjects received two 0.5 mL injections, administered four weeks apart of egg -derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 [H1N1]-like, A/Wisconsin/67/2005 [H3N2]-like and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere
Total Total of all reporting groups

Baseline Measures
    Cohort 1 + 2 (9-17 Yrs) cTIV     Cohort 1+ 2 (9-17 Yrs) eTIV_f     Cohort 3 (3-8 Yrs) cTIV     Cohort 3 (3-8 Yrs) eTIV_f     Total  
Number of Participants  
[units: participants]
  656     318     1608     1022     3604  
Age  
[units: years]
Mean ± Standard Deviation
  12.6  ± 2.6     12.6  ± 2.5     5.5  ± 1.7     5.4  ± 1.7     7.4  ± 3.7  
Gender  
[units: participants]
         
Female     304     154     795     494     1747  
Male     352     164     813     528     1857  



  Outcome Measures
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1.  Primary:   Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children   [ Time Frame: Day 50 post vaccination ]

2.  Primary:   Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children   [ Time Frame: Day 50 post vaccination ]

3.  Secondary:   Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents   [ Time Frame: Day 29 post vaccination ]

4.  Secondary:   Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents.   [ Time Frame: Day 29 post vaccination ]

5.  Secondary:   Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents   [ Time Frame: Day 29 post vaccination ]

6.  Secondary:   Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents   [ Time Frame: Day 29 post vaccination ]

7.  Secondary:   Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children   [ Time Frame: Day 29 and Day 50 post vaccination ]

8.  Secondary:   Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children   [ Time Frame: Day 29 and Day 50 post vaccination ]

9.  Secondary:   Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children   [ Time Frame: Day 29 and Day 50 post vaccination ]

10.  Secondary:   Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children   [ Time Frame: Day 29 and Day 50 post vaccination ]

11.  Secondary:   Number of Subjects Reporting Local* and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents.   [ Time Frame: up to 7 days after vaccination ]

12.  Secondary:   Number of Subjects Reporting Local* and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children.   [ Time Frame: up to 7 days after each vaccination ]


  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 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:

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00645411     History of Changes
Other Study ID Numbers: V58P12, Eudract Number: 2007-001534-13
Study First Received: March 21, 2008
Results First Received: November 21, 2012
Last Updated: January 15, 2013
Health Authority: Hungary: National Institute of Pharmacy
Romania: National Medicines Agency
Lithuania: State Medicines Control Agency
ITALY: Agenzia Italiana del Farmaco (AIFA)
Finland: National Agency for Medicines (NAM)
United States: Food and Drug Administration
Croatia: Ministry of Health and Social Care