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Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00383123
First received: September 29, 2006
Last updated: December 15, 2011
Last verified: December 2011
History of Changes
Results First Received: October 15, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Conditions: Influenza
Influenza Vaccines
Interventions: Biological: Fluarix™
Biological: Fluzone

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two subjects, enrolled in the Fluzone Group, were not vaccinated; therefore, they were not included in the number of subjects included under "STARTED".

Reporting Groups
  Description
Fluarix Group

Subjects in this group received Fluarix™ and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years
Fluzone Group

Subjects in this group received Fluzone and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years

Participant Flow:   Overall Study
    Fluarix Group     Fluzone Group  
STARTED     2115     1210  
COMPLETED     2004     1124  
NOT COMPLETED     111     86  
Adverse Event                 1                 0  
Lost to Follow-up                 68                 61  
Protocol Violation                 5                 1  
Withdrawal by Subject                 27                 18  
Other reason                 10                 6  



  Baseline Characteristics
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Reporting Groups
  Description
Fluarix Group

Subjects in this group received Fluarix™ and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years
Fluzone Group

Subjects in this group received Fluzone and will be further stratified by 3 age groups

  • 1:1 in 6 months to < 36 months
  • 1:1 in 3 to < 5 years
  • 3:1 in 5 to < 18 years
Total Total of all reporting groups

Baseline Measures
    Fluarix Group     Fluzone Group     Total  
Number of Participants  
[units: participants]
 		  2115     1210     3325  
Age  
[units: years]
Mean ± Standard Deviation 		  7.6  ± 4.97     5.5  ± 4.75     6.8  ± 4.99  
Gender  
[units: subjects]
 		     
Female     1038     586     1624  
Male     1077     624     1701  



  Outcome Measures
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1.  Primary:   Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies   [ Time Frame: 21 or 28 days after last vaccine dose ]
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2.  Primary:   Number of Seroconverted Subjects   [ Time Frame: 21 or 28 days after last vaccine dose ]
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3.  Primary:   Number of Subjects Reporting Rare Serious Events   [ Time Frame: Up to 6 months after vaccination ]
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4.  Secondary:   Number of Seroprotected Subjects   [ Time Frame: Before (PRE) and 21 or 28 days after (POST) the last vaccine dose ]
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5.  Secondary:   Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer   [ Time Frame: 21 or 28 days after last vaccine dose ]
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6.  Secondary:   Number of Subjects Reporting Solicited Local and General Symptoms   [ Time Frame: During a 4-day follow-up period after each vaccination ]
  Show Outcome Measure 6

7.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events   [ Time Frame: Within 28 days following vaccination ]
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8.  Secondary:   Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE)   [ Time Frame: Up to 6 months after vaccination ]
  Show Outcome Measure 8


  Serious Adverse Events
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  Other Adverse Events
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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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:
Baxter R et al. (2010) A phase III evaluation of immunogenicity and safety of two trivalent inactivated seasonal influenza vaccines in US children. Pediatr Infect Dis J. 29(10):924-930.

Publications automatically indexed to this study:


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00383123     History of Changes
Other Study ID Numbers: 104858
Study First Received: September 29, 2006
Results First Received: October 15, 2008
Last Updated: December 15, 2011
Health Authority: United States: Food and Drug Administration