Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01209780
First received: September 24, 2010
Last updated: February 7, 2014
Last verified: February 2014
Results First Received: December 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Seasonal Influenza
Interventions: Biological: TIV
Biological: TIVf
Biological: Comparator TIV

  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
The study was conducted in 13 centers across 4 countries: Mexico, Colombia, Panama and Philippines.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Due to GCP non-compliance at the Mexico site, data of 312 subjects (3-8 year olds) enrolled from this site were excluded from the final immunogenicity and safety analysis. The population was analyzed in the enrolled set.

Reporting Groups
  Description
TIV (3-8 Years Old) The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
Control (4-8 Years) The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of US licensed control vaccine- TIVf.
Control (3 to < 4 Years) The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination.The non-naive subjects received one dose and naive subjects received two doses of US licensed control vaccine- comparator TIV.
TIV (9-17 Years) All subjects in this group were non-naive and received one dose of investigational TIV.
Control (9-17 Years) All subjects in this group were non-naive and received one dose of US licensed control vaccine TIVf.

Participant Flow:   Overall Study
    TIV (3-8 Years Old)     Control (4-8 Years)     Control (3 to < 4 Years)     TIV (9-17 Years)     Control (9-17 Years)  
STARTED     1042     485     48     817     412  
COMPLETED     1016     467     44     807     407  
NOT COMPLETED     26     18     4     10     5  
Adverse Event                 0                 1                 0                 0                 0  
Withdrawal by Subject                 9                 2                 1                 1                 0  
Lost to Follow-up                 17                 12                 3                 9                 4  
Protocol Violation                 0                 1                 0                 0                 0  
Inappropriate enrollment                 0                 2                 0                 0                 1  



  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.
Demography reported for all enrolled set except for 312 subjects (3-8 year olds) who were enrolled in the Mexico site.

Reporting Groups
  Description
TIV (3-8 Years) The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
Control (3-8 Years) The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of vaccine.
TIV (9-17 Years) All subjects received one dose of investigational TIV.
Control (9-17 Years) All subjects received one dose of control TIV (eTIV_f).
Total Total of all reporting groups

Baseline Measures
    TIV (3-8 Years)     Control (3-8 Years)     TIV (9-17 Years)     Control (9-17 Years)     Total  
Number of Participants  
[units: participants]
  1042     533     817     412     2804  
Age  
[units: years]
Mean ± Standard Deviation
  5.6  ± 1.6     5.6  ± 1.6     12.4  ± 2.4     12.3  ± 2.3     8.6  ± 3.9  
Gender  
[units: participants]
         
Female     517     269     398     215     1399  
Male     525     264     419     197     1405  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of the Percentage of Subjects Achieving Seroconversion   [ Time Frame: Day 22 for non-naive/Day 50 for naive subjects ]

2.  Primary:   Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of Post Vaccination Geometric Mean Titers (GMTs)   [ Time Frame: Day 22 for non-naive/Day 50 for naive subjects ]

3.  Secondary:   Percentages of Subjects Achieving HI Titers ≥40 Following Vaccination With Investigational TIV or Control Vaccine.   [ Time Frame: Day 22 for non-naive/Day 50 for naive subjects ]

4.  Secondary:   Percentages of Subjects With Seroconversion in Antibody Titers Following Vaccination With Investigational TIV or Control Vaccine   [ Time Frame: Day 22 for non-naive/Day 50 for naive ]

5.  Secondary:   Percentages of Vaccine-naive Children Achieving HI Titers ≥40 After Receiving Two Doses of Investigational TIV or Control Vaccine.   [ Time Frame: Day 1, Day 29, and Day 50 ]

6.  Secondary:   Percentages of Vaccine-naive Children Achieving Seroconversion in Antibody Titers, After Receiving Two Doses of Investigational TIV or Control Vaccine   [ Time Frame: Day 29 and Day 50 ]

7.  Secondary:   Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine   [ Time Frame: Day 1 to 7 after vaccination ]

8.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine   [ Time Frame: Day 1 to 180 (non-naive )/Day 1 to 209 (naive) ]


  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 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.


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
Due to GCP non-compliance at the Mexico site, data of 312 subjects (3-8 year olds) enrolled from this site were excluded from the final immunogenicity and safety analysis.  


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


No publications provided


Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01209780     History of Changes
Other Study ID Numbers: V71_18
Study First Received: September 24, 2010
Results First Received: December 10, 2013
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration
Philippines : Food and Drug Administration
Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Panama: Instituto Conmemorativo Gorgas de Estudios en la Salud
Mexico: Comision Federal para la Protección contra Riesgos Sanitarios