A Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01218308
First received: October 7, 2010
Last updated: April 17, 2013
Last verified: April 2013
Results First Received: February 21, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Seasonal Influenza
Interventions: Biological: Quadrivalent seasonal influenza vaccine GSK2282512A
Biological: Havrix™

  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
A total of 5168 subjects have been enrolled in this study. Primed subjects had received at least 1 dose of an influenza A (H1N1) 2009 monovalent vaccine and had received 2 doses of seasonal influenza vaccine. Unprimed subjects had not received any influenza A (H1N1) 2009 monovalent vaccine or seasonal influenza vaccine.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The duration of the study was approximately 4-8 weeks to complete enrolment, with at least six months extended safety follow-up (ESFU) after first vaccination, and lasted until the end of the influenza like illness (ILI) surveillance period. The ESFU results were not available at this point and will be updated when data become available.

Reporting Groups
  Description
GSK2282512A Group Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of GSK2282512A vaccine at Day 0 and, if unprimed, 2 doses of GSK2282512A vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Havrix Group Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Participant Flow:   Overall Study
    GSK2282512A Group     Havrix Group  
STARTED     2584     2584  
COMPLETED     2481     2464  
NOT COMPLETED     103     120  
Adverse Event                 1                 2  
Protocol Violation                 0                 2  
Withdrawal by Subject                 61                 64  
Lost to Follow-up                 27                 31  
Unspecified                 14                 21  



  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
GSK2282512A Group Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of GSK2282512A vaccine at Day 0 and, if unprimed, 2 doses of GSK2282512A vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Havrix Group Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
Total Total of all reporting groups

Baseline Measures
    GSK2282512A Group     Havrix Group     Total  
Number of Participants  
[units: participants]
  2584     2584     5168  
Age  
[units: Years]
Mean ± Standard Deviation
  5.4  ± 1.66     5.4  ± 1.65     5.4  ± 1.65  
Gender  
[units: Subjects]
     
Female     1251     1245     2496  
Male     1333     1339     2672  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects Reporting at Least One Confirmed Occurrence of Influenza A or B.   [ Time Frame: From Day 14 to Day 180 ]

2.  Secondary:   Number of Subjects Reporting at Least One Moderate to Severe Occurrence of Influenza A or B.   [ Time Frame: From Day 14 to Day 180 ]

3.  Secondary:   Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Antigenically Matched Strain.   [ Time Frame: From Day 14 to Day 180 ]

4.  Secondary:   Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Any Strain.   [ Time Frame: From Day 14 to Day 180 ]

5.  Secondary:   Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.   [ Time Frame: At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST] ]

6.  Secondary:   Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.   [ Time Frame: At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST] ]

7.  Secondary:   Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.   [ Time Frame: At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST] ]

8.  Secondary:   Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.   [ Time Frame: At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST] ]

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

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

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

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

13.  Secondary:   Number of Subjects With Any and Related Medically Attended Adverse Events (MAEs).   [ Time Frame: During the entire study period (Day 0 - Day 180) ]

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

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


  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: NCT01218308     History of Changes
Other Study ID Numbers: 114541
Study First Received: October 7, 2010
Results First Received: February 21, 2013
Last Updated: April 17, 2013
Health Authority: Philippines: Philippines Food and Drug Administration
Lebanon: Republic of Lebanon, Ministry of Health
Turkey: Ministry of Health of Turkey, General Directorate of Pharmaceuticals and Pharmacy
Honduras: Secretaria de Salud de Honduras
United States: Food and Drug Administration
Panama: Departamento de Farmacia y Drogas, Ministerio de Salud de Panama
Dominican Republic: Ministerio de Salud Publica de Republica Dominicana/Direccion general de Drogas y Farmacia, Ministerio de Garantia de Calidad
Thailand: Ministry of Public Health
Bangladesh: Drug Administration Authority, Bangladesh
India: Drugs Controller General of India (DCGI)