Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children

This study has been terminated.
(The study was terminated for logistic reasons not related to safety or efficacy of the vaccine.)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01195779
First received: September 3, 2010
Last updated: June 15, 2012
Last verified: June 2012
Results First Received: March 22, 2012  
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: Influenza Disease
Interventions: Biological: GSK Bio's influenza vaccine GSK2584786A, different formulations
Biological: GSK Bio's influenza vaccine GSK2321138A
Biological: Fluarix™

  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
Since this study was prematurely terminated (not because of safety issues or lack of immunogenicity but for logistic reasons) only 4 of 1120 planned subjects were enrolled.

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
GSK2584786A Vaccine 1 Dose of Formulation A1 Group Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
GSK2584786A Vaccine 2 Doses of Formulation A1 Group Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
GSK2584786A Vaccine 1 Dose of Formulation A2 Group Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
GSK2584786A Vaccine 2 Doses of Formulation A2 Group Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
GSK2584786A Vaccine 1 Dose of Formulation A3 Group Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
GSK2584786A Vaccine 2 Doses of Formulation A3 Group Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
GSK2584786A Vaccine 1 Dose of Formulation B1 Group Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
GSK2584786A Vaccine 2 Doses of Formulation B1 Group Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
GSK2584786A Vaccine 1 Dose of Formulation B2 Group Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
GSK2584786A Vaccine 2 Doses of Formulation B2 Group Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
GSK2584786A Vaccine 1 Dose of Formulation B3 Group Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
GSK2584786A Vaccine 2 Doses of Formulation B3 Group Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
GSK2321138A Vaccine Group Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
Fluarix Group Subjects received 2 doses of Fluarix Vaccine.

Participant Flow:   Overall Study
    GSK2584786A Vaccine 1 Dose of Formulation A1 Group     GSK2584786A Vaccine 2 Doses of Formulation A1 Group     GSK2584786A Vaccine 1 Dose of Formulation A2 Group     GSK2584786A Vaccine 2 Doses of Formulation A2 Group     GSK2584786A Vaccine 1 Dose of Formulation A3 Group     GSK2584786A Vaccine 2 Doses of Formulation A3 Group     GSK2584786A Vaccine 1 Dose of Formulation B1 Group     GSK2584786A Vaccine 2 Doses of Formulation B1 Group     GSK2584786A Vaccine 1 Dose of Formulation B2 Group     GSK2584786A Vaccine 2 Doses of Formulation B2 Group     GSK2584786A Vaccine 1 Dose of Formulation B3 Group     GSK2584786A Vaccine 2 Doses of Formulation B3 Group     GSK2321138A Vaccine Group     Fluarix Group  
STARTED     0     0     0     0     1     0     0     1     0     0     0     1     0     1  
COMPLETED     0     0     0     0     1     0     0     1     0     0     0     1     0     1  
NOT COMPLETED     0     0     0     0     0     0     0     0     0     0     0     0     0     0  



  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
GSK2584786A Vaccine 1 Dose of Formulation A1 Group Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
GSK2584786A Vaccine 2 Doses of Formulation A1 Group Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
GSK2584786A Vaccine 1 Dose of Formulation A2 Group Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
GSK2584786A Vaccine 2 Doses of Formulation A2 Group Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
GSK2584786A Vaccine 1 Dose of Formulation A3 Group Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
GSK2584786A Vaccine 2 Doses of Formulation A3 Group Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
GSK2584786A Vaccine 1 Dose of Formulation B1 Group Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
GSK2584786A Vaccine 2 Doses of Formulation B1 Group Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
GSK2584786A Vaccine 1 Dose of Formulation B2 Group Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
GSK2584786A Vaccine 2 Doses of Formulation B2 Group Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
GSK2584786A Vaccine 1 Dose of Formulation B3 Group Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
GSK2584786A Vaccine 2 Doses of Formulation B3 Group Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
GSK2321138A Vaccine Group Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
Fluarix Group Subjects received 2 doses of Fluarix Vaccine.
Total Total of all reporting groups

Baseline Measures
    GSK2584786A Vaccine 1 Dose of Formulation A1 Group     GSK2584786A Vaccine 2 Doses of Formulation A1 Group     GSK2584786A Vaccine 1 Dose of Formulation A2 Group     GSK2584786A Vaccine 2 Doses of Formulation A2 Group     GSK2584786A Vaccine 1 Dose of Formulation A3 Group     GSK2584786A Vaccine 2 Doses of Formulation A3 Group     GSK2584786A Vaccine 1 Dose of Formulation B1 Group     GSK2584786A Vaccine 2 Doses of Formulation B1 Group     GSK2584786A Vaccine 1 Dose of Formulation B2 Group     GSK2584786A Vaccine 2 Doses of Formulation B2 Group     GSK2584786A Vaccine 1 Dose of Formulation B3 Group     GSK2584786A Vaccine 2 Doses of Formulation B3 Group     GSK2321138A Vaccine Group     Fluarix Group     Total  
Number of Participants  
[units: participants]
  0     0     0     0     1     0     0     1     0     0     0     1     0     1     4  
Age  
[units: Months]
Mean ± Standard Deviation
                             
Months                     28  ± NA [1]           17  ± NA [1]               14  ± NA [1]       14  ± NA [1]   18.25  ± 6.65  
Gender  
[units: Subjects]
                             
Female                     0             1                 0         1     2  
Male                     1             0                 1         0     2  
[1] Since only a single subject was enrolled in 4 of the study groups, there was insufficient data to calculate the within-group standard deviation.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Serum Haemagglutination-inhibition (HI) Antibody Titers   [ Time Frame: at Day 28/ Day 56 ]

2.  Primary:   Serum Neutralizing Antibody Titers   [ Time Frame: at Day 28/ Day 56 ]

3.  Primary:   Geometric Mean Number of All-CD4 Cytokine Positive Cells   [ Time Frame: at Day 28/ Day 56 ]

4.  Primary:   Number of Subjects Reporting Fever of at Least Grade 2 or Higher   [ Time Frame: Within 7 days (Day 0 to 6) follow-up period after any dose of study vaccine ]

5.  Secondary:   Serum HI Antibody Titers   [ Time Frame: on Days 0, 28/56 and 180 ]

6.  Secondary:   Serum Neutralising Antibody Titers   [ Time Frame: on Days 0, 28/56 and 180 ]

7.  Secondary:   Number of Subjects Reporting Solicited Local and General Symptoms   [ Time Frame: during a 7 day follow-up period (Day 0 to 6) after any vaccination ]

8.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events (AEs)   [ Time Frame: within 28 days (Day 0 to Day 27) after any vaccination ]

9.  Secondary:   Number of Subjects Reporting Adverse Events With Medically Attended Visits   [ Time Frame: From Day 0 to 179 ]

10.  Secondary:   Number of Subjects Reporting Potential Immune-mediated Diseases   [ Time Frame: From Day 0 to 179 ]

11.  Secondary:   Number of Subjects Reporting Serious Adverse Events   [ Time Frame: From Day 0 to 179 ]


  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
No text entered.


  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


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01195779     History of Changes
Other Study ID Numbers: 114294
Study First Received: September 3, 2010
Results First Received: March 22, 2012
Last Updated: June 15, 2012
Health Authority: Finland: Ministry of Social Affairs and Health