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

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ClinicalTrials.gov Identifier: NCT01218308
Recruitment Status : Completed
First Posted : October 11, 2010
Results First Posted : April 2, 2013
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: FluLaval® Quadrivalent
Biological: Havrix™

  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 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.

Reporting Groups
  Description
FluLaval® Quadrivalent Group Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent 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
    FluLaval® Quadrivalent 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 
Other                14                21 



  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
FluLaval® Quadrivalent Group Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent 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
   FluLaval® Quadrivalent Group   Havrix Group   Total 
Overall Participants Analyzed 
[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

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:   Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Strains   [ Time Frame: On Day 0 and at least 6 months after first vaccination (Month 6) ]

10.  Secondary:   Number of Seroconverted Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains.   [ Time Frame: At least 6 months after first vaccination (Month 6) ]

11.  Secondary:   Number of Seroprotected Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains.   [ Time Frame: At Day 0 and at least 6 months after first vaccination (Month 6) ]

12.  Secondary:   Seroconversion Factors for HI Antibodies Against 4 Strains of Influenza Disease.   [ Time Frame: At least 6 months after first vaccination (Month 6) ]

13.  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 ]

14.  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 ]

15.  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 ]

16.  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 ]

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

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

19.  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

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

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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01218308     History of Changes
Other Study ID Numbers: 114541
First Submitted: October 7, 2010
First Posted: October 11, 2010
Results First Submitted: February 21, 2013
Results First Posted: April 2, 2013
Last Update Posted: October 7, 2016