Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00764790
First received: October 1, 2008
Last updated: October 11, 2012
Last verified: October 2012
Results First Received: February 25, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Caregiver, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza
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
No text entered.

Reporting Groups
  Description
Fluarix Dose A Group

Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).

* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

Fluarix Dose B Group

Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).

* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

Fluzone Group

Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).

* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.


Participant Flow:   Overall Study
    Fluarix Dose A Group     Fluarix Dose B Group     Fluzone Group  
STARTED     1107     1106     1104  
COMPLETED     1069     1065     1074  
NOT COMPLETED     38     41     30  
Protocol Violation                 0                 0                 1  
Withdrawal by Subject                 10                 12                 6  
Lost to Follow-up                 28                 29                 23  



  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
Fluarix Dose A Group

Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).

* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

Fluarix Dose B Group

Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).

* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

Fluzone Group

Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).

* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.

Total Total of all reporting groups

Baseline Measures
    Fluarix Dose A Group     Fluarix Dose B Group     Fluzone Group     Total  
Number of Participants  
[units: participants]
  1107     1106     1104     3317  
Age  
[units: months]
Mean ± Standard Deviation
  20.9  ± 8.07     20.9  ± 8.42     21.0  ± 8.23     20.9  ± 8.24  
Gender  
[units: subjects]
       
Female     539     517     560     1616  
Male     568     589     544     1701  



  Outcome Measures
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1.  Primary:   Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains   [ Time Frame: Day 0 (PRE), Day 28 or Day 56 (POST) ]

2.  Primary:   Number of Subjects Who Seroconverted   [ Time Frame: Day 28 or Day 56 ]

3.  Secondary:   Number of Seroprotected Subjects   [ Time Frame: Day 0 (PRE), Day 28 or Day 56 (POST) ]

4.  Secondary:   Seroconversion Factor   [ Time Frame: Day 28 or Day 56 ]

5.  Secondary:   Number of Subjects Reporting Solicited Local Symptoms   [ Time Frame: During a 4-day follow-up period after vaccination ]

6.  Secondary:   Number of Subjects Reporting Solicited General Symptoms   [ Time Frame: During a 4-day follow-up period after vaccination ]

7.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events (AE)   [ Time Frame: During a 28-day follow-up period after vaccination ]

8.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAE) and New Onset of Chronic Diseases (NOCD)   [ Time Frame: During the entire study (Day 0 until Month 6) ]

9.  Secondary:   Number of Subjects Reporting Rare Serious Events   [ Time Frame: During the entire study (Day 0 until Month 6) ]


  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 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.


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


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00764790     History of Changes
Other Study ID Numbers: 111751
Study First Received: October 1, 2008
Results First Received: February 25, 2010
Last Updated: October 11, 2012
Health Authority: Taiwan: Department of Health
Thailand: Ministry of Public Health
Hong Kong: Department of Health
Mexico: Ministry of Health
United States: Food and Drug Administration