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Clinical Study in Children, 6 Months to 3 Years of Age, to Assess Two Dose Levels of an Experimental Flu Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control

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ClinicalTrials.gov Identifier: NCT00778895
Recruitment Status : Completed
First Posted : October 24, 2008
Results First Posted : July 9, 2013
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: GSK Biologicals' influenza vaccine GSK1557482A
Biological: Vaxigrip

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were differentiated according to priming status. Primed Subjects – subjects who had a prior 2-dose priming influenza immunization received a 1-dose vaccination course in the study. Unprimed Subjects – subjects who had not previously received a complete 2-dose priming influenza immunization received a 2-dose vaccination course in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Study comprised an Active phase of approximately 2 months and a post-vaccination 180 day extended safety follow-up period (ESFU phase).

374 subjects out of the 390 who were enrolled in the study were vaccinated. Remaining subjects were not included in the participant flow as started as they failed to meet protocol criteria.


Reporting Groups
  Description
Fluviral F1 Group Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
Fluviral F2 Group Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
Vaxigrip Group Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.

Participant Flow for 2 periods

Period 1:   Active Phase
    Fluviral F1 Group   Fluviral F2 Group   Vaxigrip Group
STARTED   164   167   43 
COMPLETED   157   161   43 
NOT COMPLETED   7   6   0 
Adverse Event                3                1                0 
Withdrawal by Subject                1                4                0 
Lost to Follow-up                1                1                0 
Other                2                0                0 

Period 2:   ESFU Phase
    Fluviral F1 Group   Fluviral F2 Group   Vaxigrip Group
STARTED   164   167   43 
COMPLETED   153   155   41 
NOT COMPLETED   11   12   2 
Adverse Event                2                1                0 
Withdrawal by Subject                1                4                0 
Lost to Follow-up                6                7                2 
Other                2                0                0 



  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
Fluviral F1 Group Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
Fluviral F2 Group Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
Vaxigrip Group Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
Total Total of all reporting groups

Baseline Measures
   Fluviral F1 Group   Fluviral F2 Group   Vaxigrip Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 164   167   43   374 
Age 
[Units: Years]
Mean (Standard Deviation)
 18.2  (9.06)   17.5  (8.27)   17.0  (8.33)   17.7  (8.62) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      70  42.7%      83  49.7%      26  60.5%      179  47.9% 
Male      94  57.3%      84  50.3%      17  39.5%      195  52.1% 


  Outcome Measures

1.  Primary:   Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination   [ Time Frame: During the 4-day follow-up period (Days 0-3) after any vaccination ]

2.  Primary:   Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination   [ Time Frame: During the 4-day follow-up period (Days 0-3) after any vaccination ]

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

4.  Primary:   Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination   [ Time Frame: During the 28-day post-vaccination period ]

5.  Primary:   Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination   [ Time Frame: During the 6-month safety follow up after vaccination ]

6.  Primary:   Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination   [ Time Frame: During the 28-day post-vaccination period ]

7.  Primary:   Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination   [ Time Frame: During the 6-month safety follow up after vaccination ]

8.  Secondary:   Titers for Serum Hemagglutination Inhibition (HI) Antibodies   [ Time Frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST] ]

9.  Secondary:   Number of Subjects Seroconverted to HI Antibodies   [ Time Frame: At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST] ]

10.  Secondary:   Number of Subjects Seroprotected Against HI Antibodies   [ Time Frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST] ]

11.  Secondary:   Seroconversion Factor for HI Antibodies   [ Time Frame: At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST] ]

12.  Secondary:   Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination   [ Time Frame: During the 4-day follow-up period (Days 0-3) after any vaccination ]

13.  Secondary:   Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination   [ Time Frame: During the 4-day follow-up period (Days 0-3) after any vaccination ]

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

15.  Secondary:   Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination   [ Time Frame: During the 28-day post-vaccination period after vaccination ]

16.  Secondary:   Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination   [ Time Frame: During the 6-month safety follow up after vaccination ]

17.  Secondary:   Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination   [ Time Frame: During the 28-day post-vaccination period ]

18.  Secondary:   Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination   [ Time Frame: During the 6-month safety follow up after vaccination ]


  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: NCT00778895     History of Changes
Other Study ID Numbers: 111635
First Submitted: October 23, 2008
First Posted: October 24, 2008
Results First Submitted: December 19, 2012
Results First Posted: July 9, 2013
Last Update Posted: August 17, 2018