Immunogenicity and Safety Study of a GlaxoSmithKline Biologicals' Candidate Influenza Vaccine in Healthy Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00985790
First received: September 24, 2009
Last updated: February 7, 2013
Last verified: February 2013
Results First Received: November 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Conditions: Influenza
Influenza Vaccines
Interventions: Biological: Influenza vaccine GSK2321138A
Biological: Fluarix™

  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 599 subjects were enrolled in the study, and assigned to either the GSK2321138A Group (298 subjects) or the Fluarix Group (301 subjects). Duration of study was of approximately 6 months for each subject.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
For demography and safety, results are presented as per the main study groups. For some outcome measures and where relevant, subjects as in these 2 main groups are split according to their priming status at study entry.

Reporting Groups
  Description
GSK2321138A Group Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
Fluarix Group Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.

Participant Flow:   Overall Study
    GSK2321138A Group     Fluarix Group  
STARTED     298 [1]   301 [2]
COMPLETED     291     293  
NOT COMPLETED     7     8  
Withdrawal by Subject                 1                 1  
Lost to Follow-up                 6                 7  
[1] 95 were primed and 203 were unprimed subjects.
[2] 97 were primed and 204 were unprimed subjects.



  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
GSK2321138A Group Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
Fluarix Group Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
Total Total of all reporting groups

Baseline Measures
    GSK2321138A Group     Fluarix Group     Total  
Number of Participants  
[units: participants]
  298     301     599  
Age  
[units: months]
Mean ± Standard Deviation
  31.4  ± 8.46     31.6  ± 8.29     31.5  ± 8.38  
Gender  
[units: subjects]
     
Female     138     147     285  
Male     160     154     314  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains.   [ Time Frame: At Day 0 [PRE] and at 28 days post last vaccination (Day 28 or Day 56) [POST] ]

2.  Secondary:   Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.   [ Time Frame: At Days 0 and 28. ]

3.  Secondary:   Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.   [ Time Frame: At Days 0, 28 and Day 56 ]

4.  Secondary:   Number of Seropositive Subjects Against 4 Strains of Influenza Disease.   [ Time Frame: At Days 0 and 28 ]

5.  Secondary:   Number of Seropositive Subjects Against 4 Strains of Influenza Disease.   [ Time Frame: At Days 0, 28 and 56 ]

6.  Secondary:   Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.   [ Time Frame: At Day 28 ]

7.  Secondary:   Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.   [ Time Frame: At Days 28 and 56 ]

8.  Secondary:   Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.   [ Time Frame: At Day 28 ]

9.  Secondary:   Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.   [ Time Frame: At Days 28 and 56 ]

10.  Secondary:   Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.   [ Time Frame: At Days 0 and 28 ]

11.  Secondary:   Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.   [ Time Frame: At Days 0, 28 and 56 ]

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

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

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

15.  Secondary:   Number of Subjects With Any and Related Serious Adverse Events (SAEs).   [ Time Frame: From Day 0 to Day 180 (study conclusion) ]

16.  Secondary:   Number of Subjects With Any Adverse Events of Specific Interest (AESIs).   [ Time Frame: From Day 0 to Day 180 (study conclusion) ]


  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


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00985790     History of Changes
Other Study ID Numbers: 113237
Study First Received: September 24, 2009
Results First Received: November 28, 2012
Last Updated: February 7, 2013
Health Authority: Mexico: Comisión Federal para la protección contra riezgos Sanitarios, Secretaría de Salud