A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01198756
First received: September 9, 2010
Last updated: February 7, 2013
Last verified: January 2013
Results First Received: December 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Influenza, Human
Seasonal Influenza
Interventions: Biological: Quadrivalent seasonal influenza vaccine GSK2282512A
Biological: Fluarix™ VB
Biological: Fluarix™ YB

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 3109 subjects were enrolled, out of which solely 3094 subjects were vaccinated who constituted the analysed population in this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Unprimed Subjects – subjects aged 6 months to 8 years with no H1N1 vaccine or H1N1 infection in the last season, or with no seasonal influenza vaccine in the past or who had received only 1 dose for the first time in the last season – received a 2-dose vaccination course. Primed Subjects – all other subjects – received a 1-dose vaccination course.

Reporting Groups
  Description
GSK2282512A 1 Group Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Victoria Strain Fluarix Group Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Yamagata Strain Fluarix Group Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
GSK2282512A 2 Group Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.

Participant Flow:   Overall Study
    GSK2282512A 1 Group     Victoria Strain Fluarix Group     Yamagata Strain Fluarix Group     GSK2282512A 2 Group  
STARTED     932     929     932     301  
COMPLETED     894     889     902     275  
NOT COMPLETED     38     40     30     26  
Adverse Event                 0                 0                 0                 1  
Protocol Violation                 0                 0                 0                 2  
Withdrawal by Subject                 9                 4                 7                 5  
Lost to Follow-up                 29                 36                 23                 18  



  Baseline Characteristics
  Hide Baseline Characteristics

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
GSK2282512A 1 Group Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Victoria Strain Fluarix Group Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Yamagata Strain Fluarix Group Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
GSK2282512A 2 Group Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
Total Total of all reporting groups

Baseline Measures
    GSK2282512A 1 Group     Victoria Strain Fluarix Group     Yamagata Strain Fluarix Group     GSK2282512A 2 Group     Total  
Number of Participants  
[units: participants]
  932     929     932     301     3094  
Age  
[units: Years]
Mean ± Standard Deviation
  8.9  ± 4.21     8.9  ± 4.23     8.9  ± 4.17     1.2  ± 0.73     8.1  ± 4.60  
Gender  
[units: subjects]
         
Female     434     455     464     143     1496  
Male     498     474     468     158     1598  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease   [ Time Frame: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) ]

2.  Primary:   Number of Subjects Seroconverted Against 4 Strains of Influenza Disease   [ Time Frame: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) ]

3.  Secondary:   Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease   [ Time Frame: At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) ]

4.  Secondary:   Number of Subjects Seroprotected Against 4 Strains of Influenza Disease   [ Time Frame: At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) ]

5.  Secondary:   Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease   [ Time Frame: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) ]

6.  Secondary:   Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease - By Age Strata   [ Time Frame: At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) ]

7.  Secondary:   Number of Subjects Seroconverted Against 4 Strains of Influenza Disease - By Age Strata   [ Time Frame: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) ]

8.  Secondary:   Number of Subjects Seroprotected Against 4 Strains of Influenza Disease - By Age Strata   [ Time Frame: At Day 0 and at 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) ]

9.  Secondary:   Seroconversion Factor for Hemagglutination Inhibition Antibodies Against 4 Strains of Influenza Disease - By Age Strata   [ Time Frame: At 28 days after administration of the last vaccine dose (Day 28 for Primed Subjects and at Day 56 for Unprimed Subjects) (POST) ]

10.  Secondary:   Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination   [ Time Frame: During the 7-day follow-up period (Days 0-6) after vaccination ]

11.  Secondary:   Number of Days With Solicited Local Symptoms After Vaccination   [ Time Frame: During the 7-day follow-up period (Days 0-6) after vaccination ]

12.  Secondary:   Number of Subjects Below 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: During the 7-day follow-up period (Days 0-6) after vaccination ]

13.  Secondary:   Number of Subjects 5 Years of Age and Above With Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: During the 7-day follow-up period (Days 0-6) after vaccination ]

14.  Secondary:   Number of Days With Solicited General Symptoms After Vaccination in Subjects Below 5 Years of Age   [ Time Frame: During the 7-day follow-up period (Days 0-6) after vaccination ]

15.  Secondary:   Number of Days With Solicited General Symptoms After Vaccination in Subjects 5 Years of Age and Above   [ Time Frame: During the 7-day follow-up period (Days 0-6) after vaccination ]

16.  Secondary:   Number of Days With Fever in All Subjects Regardless of Their Age After Vaccination   [ Time Frame: During the 7-day follow-up period (Days 0-6) after vaccination ]

17.  Secondary:   Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)   [ Time Frame: During the 28-day follow-up period (Day 0-27) after vaccination ]

18.  Secondary:   Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) After Vaccination   [ Time Frame: During the entire study period (from Day 0 to Day 180) ]

19.  Secondary:   Number of Subjects With Any and Related Medically-attended Adverse Events (MAEs) After Vaccination   [ Time Frame: During the entire study period (from Day 0 to Day 180) ]

20.  Secondary:   Number of Subjects With Any and Related Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period (from Day 0 to Day 180) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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


Publications:
Langley JM et al. Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine Candidate: a Randomized Controlled Trial in Children. Abstract presented at the 50th Annual Meeting, Infectious Diseases Society of America - (IDSA-IDWeek), San Diego, 17-21 October 2012.

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01198756     History of Changes
Other Study ID Numbers: 113314
Study First Received: September 9, 2010
Results First Received: December 6, 2012
Last Updated: February 7, 2013
Health Authority: Mexico: Comision Federal de prevencion contra riesgos sanitarios
Taiwan: Food and Drug Administration, Department of Health, Executive Yuan
United States: Food and Drug Administration
Spain:Agencia Espanola de Medicamentos y Productos Sanitarios
Canada: Health Canada