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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:
ClinicalTrials.gov Identifier:
NCT01209780
First Posted: September 27, 2010
Last Update Posted: March 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
Results First Submitted: December 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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 
Overall Participants Analyzed 
[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


  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
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.


  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



Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01209780     History of Changes
Other Study ID Numbers: V71_18
First Submitted: September 24, 2010
First Posted: September 27, 2010
Results First Submitted: December 10, 2013
Results First Posted: March 11, 2014
Last Update Posted: March 11, 2014