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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
Enrollment 390
Recruitment Details 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

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.

Arm/Group Title Fluviral F1 Group Fluviral F2 Group Vaxigrip Group
Hide Arm/Group Description 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. 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. 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.
Period Title: Active Phase
Started 164 167 43
Completed 157 161 43
Not Completed 7 6 0
Reason Not Completed
Adverse Event             3             1             0
Withdrawal by Subject             1             4             0
Lost to Follow-up             1             1             0
Other             2             0             0
Period Title: ESFU Phase
Started 164 167 43
Completed 153 155 41
Not Completed 11 12 2
Reason Not Completed
Adverse Event             2             1             0
Withdrawal by Subject             1             4             0
Lost to Follow-up             6             7             2
Other             2             0             0
Arm/Group Title Fluviral F1 Group Fluviral F2 Group Vaxigrip Group Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 164 167 43 374
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 164 participants 167 participants 43 participants 374 participants
18.2  (9.06) 17.5  (8.27) 17.0  (8.33) 17.7  (8.62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 167 participants 43 participants 374 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%
1.Primary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination
Hide Description Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Time Frame During the 4-day follow-up period (Days 0-3) after any vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.
Arm/Group Title Fluviral F1 Group Fluviral F2 Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 161 164
Measure Type: Count of Participants
Unit of Measure: Participants
Any pain
45
  28.0%
55
  33.5%
Grade 3 pain
1
   0.6%
1
   0.6%
Any redness
49
  30.4%
54
  32.9%
Grade 3 redness
0
   0.0%
0
   0.0%
Any swelling
22
  13.7%
24
  14.6%
Grade 3 swelling
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination
Hide Description Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Time Frame During the 4-day follow-up period (Days 0-3) after any vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.
Arm/Group Title Fluviral F1 Group Fluviral F2 Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 161 163
Measure Type: Count of Participants
Unit of Measure: Participants
Any drowsiness
54
  33.5%
65
  39.9%
Grade 3 drowsiness
3
   1.9%
3
   1.8%
Related drowsiness
44
  27.3%
52
  31.9%
Any irritability
81
  50.3%
83
  50.9%
Grade 3 irritability
9
   5.6%
7
   4.3%
Related irritability
62
  38.5%
69
  42.3%
Any loss of appetite
50
  31.1%
54
  33.1%
Grade 3 loss of appetite
5
   3.1%
5
   3.1%
Related loss of appetite
37
  23.0%
43
  26.4%
Any fever
16
   9.9%
9
   5.5%
Grade 3 fever
4
   2.5%
1
   0.6%
Related fever
10
   6.2%
6
   3.7%
3.Primary Outcome
Title Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination
Hide Description Unsolicited AEs covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Time Frame During the 28-day follow-up period (Days 0-27) after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
Arm/Group Title Fluviral F1 Group Fluviral F2 Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 164 167
Measure Type: Count of Participants
Unit of Measure: Participants
Any unsolicited AE(s)
108
  65.9%
112
  67.1%
Grade 3 unsolicited AE(s)
19
  11.6%
17
  10.2%
Related unsolicited AE(s)
26
  15.9%
30
  18.0%
4.Primary Outcome
Title Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
Hide Description

MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

Analysis of intensity and relationship to vaccination of MAEs was not performed.

This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.

Time Frame During the 28-day post-vaccination period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
Arm/Group Title Fluviral F1 Group Fluviral F2 Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 164 167
Measure Type: Count of Participants
Unit of Measure: Participants
52
  31.7%
40
  24.0%
5.Primary Outcome
Title Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
Hide Description

MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

Analysis of intensity and relationship to vaccination of MAEs was not performed.

This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.

Time Frame During the 6-month safety follow up after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
Arm/Group Title Fluviral F1 Group Fluviral F2 Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 164 167
Measure Type: Count of Participants
Unit of Measure: Participants
73
  44.5%
57
  34.1%
6.Primary Outcome
Title Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
Hide Description

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.

This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.

Time Frame During the 28-day post-vaccination period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
Arm/Group Title Fluviral F1 Group Fluviral F2 Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 164 167
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE(s)
1
   0.6%
1
   0.6%
Related SAE(s)
0
   0.0%
0
   0.0%
7.Primary Outcome
Title Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
Hide Description

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.

This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.

Time Frame During the 6-month safety follow up after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
Arm/Group Title Fluviral F1 Group Fluviral F2 Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 164 167
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE(s)
1
   0.6%
1
   0.6%
Related SAE(s)
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Titers for Serum Hemagglutination Inhibition (HI) Antibodies
Hide Description Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida flu strains.
Time Frame At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Fluviral F1 Group Fluviral F2 Group Vaxigrip Group
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 131 132 36
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
A/Brisbane (H1N1) strain [PRE]
8.3
(6.9 to 10.1)
8.5
(7.0 to 10.3)
8.1
(5.9 to 11.0)
A/Brisbane (H1N1) strain [POST]
56.3
(39.5 to 80.2)
70.7
(50.7 to 98.6)
120.9
(73.4 to 199.0)
A/Uruguay (H3N2) strain [PRE]
7.0
(5.9 to 8.3)
9.2
(7.4 to 11.4)
7.3
(4.9 to 11.1)
A/Uruguay (H3N2) strain [POST]
64.5
(48.2 to 86.4)
89.5
(67.4 to 119.0)
97.8
(59.0 to 162.4)
B/Florida strain [PRE]
7.9
(6.7 to 9.4)
7.9
(6.6 to 9.4)
10.8
(6.9 to 16.9)
B/Florida strain [POST]
128.7
(100.3 to 165.1)
163.7
(130.1 to 206.0)
190.3
(119.0 to 304.3)
9.Secondary Outcome
Title Number of Subjects Seroconverted to HI Antibodies
Hide Description A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.
Time Frame At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Fluviral F1 Group Fluviral F2 Group Vaxigrip Group
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 131 132 36
Measure Type: Count of Participants
Unit of Measure: Participants
A/Brisbane (H1N1) [POST]
67
  51.1%
82
  62.1%
29
  80.6%
A/Uruguay (H3N2) [POST]
81
  61.8%
98
  74.2%
28
  77.8%
B/Florida [POST]
106
  80.9%
114
  86.4%
31
  86.1%
10.Secondary Outcome
Title Number of Subjects Seroprotected Against HI Antibodies
Hide Description

A seroprotected subject was defined as a vaccinated subject with serum HI titer ≥ 1:40.

The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.

Time Frame At Day 0 [PRE] and at Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Fluviral F1 Group Fluviral F2 Group Vaxigrip Group
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 131 132 36
Measure Type: Count of Participants
Unit of Measure: Participants
A/Brisbane (H1N1) [PRE]
17
  13.0%
21
  15.9%
5
  13.9%
A/Brisbane (H1N1) [POST]
70
  53.4%
84
  63.6%
30
  83.3%
A/Uruguay (H3N2) [PRE]
10
   7.6%
23
  17.4%
3
   8.3%
A/Uruguay (H3N2) [POST]
82
  62.6%
99
  75.0%
30
  83.3%
B/Florida [PRE]
17
  13.0%
20
  15.2%
7
  19.4%
B/Florida [POST]
111
  84.7%
122
  92.4%
33
  91.7%
11.Secondary Outcome
Title Seroconversion Factor for HI Antibodies
Hide Description

The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination (at Day 28 for primed subjects and at Day 56 for unprimed subjects) compared to pre-vaccination (Day 0).

The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.

Time Frame At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
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Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all vaccinated and eligible subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Arm/Group Title Fluviral F1 Group Fluviral F2 Group Vaxigrip Group
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 131 132 36
Geometric Mean (95% Confidence Interval)
Unit of Measure: fold increase
A/Brisbane (H1N1) [POST]
6.8
(5.2 to 8.9)
8.3
(6.6 to 10.6)
14.9
(9.6 to 23.3)
A/Uruguay (H3N2) [POST]
9.2
(7.3 to 11.7)
9.7
(8.0 to 11.9)
13.3
(8.9 to 19.9)
B/Florida [POST]
16.2
(12.8 to 20.5)
20.7
(16.3 to 26.2)
17.6
(10.4 to 29.9)
12.Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination
Hide Description

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.

Time Frame During the 4-day follow-up period (Days 0-3) after any vaccination
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Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.
Arm/Group Title Vaxigrip Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 43
Measure Type: Count of Participants
Unit of Measure: Participants
Any pain
17
  39.5%
Grade 3 pain
0
   0.0%
Any redness
13
  30.2%
Grade 3 redness
0
   0.0%
Any swelling
5
  11.6%
Grade 3 swelling
0
   0.0%
13.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination
Hide Description

Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination.

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.

Time Frame During the 4-day follow-up period (Days 0-3) after any vaccination
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Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and symptom sheet completed.
Arm/Group Title Vaxigrip Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 43
Measure Type: Count of Participants
Unit of Measure: Participants
Any drowsiness
16
  37.2%
Grade 3 drowsiness
0
   0.0%
Related drowsiness
11
  25.6%
Any irritability
22
  51.2%
Grade 3 irritability
1
   2.3%
Related irritability
15
  34.9%
Any loss of appetite
14
  32.6%
Grade 3 loss of appetite
0
   0.0%
Related loss of appetite
9
  20.9%
Any fever
3
   7.0%
Grade 3 fever
0
   0.0%
Related fever
2
   4.7%
14.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination
Hide Description

Unsolicited AEs covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination.

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.

Time Frame During the 28-day follow-up period (Days 0-27) after vaccination
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Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
Arm/Group Title Vaxigrip Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 43
Measure Type: Count of Participants
Unit of Measure: Participants
Any unsolicited AE(s)
24
  55.8%
Grade 3 unsolicited AE(s)
3
   7.0%
Related unsolicited AE(s)
8
  18.6%
15.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
Hide Description

MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

Analysis of intensity and relationship to vaccination of MAEs was not performed.

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.

Time Frame During the 28-day post-vaccination period after vaccination
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Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
Arm/Group Title Vaxigrip Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 43
Measure Type: Count of Participants
Unit of Measure: Participants
9
  20.9%
16.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
Hide Description

MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

Analysis of intensity and relationship to vaccination of MAEs was not performed.

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.

Time Frame During the 6-month safety follow up after vaccination
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Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
Arm/Group Title Vaxigrip Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 43
Measure Type: Count of Participants
Unit of Measure: Participants
14
  32.6%
17.Secondary Outcome
Title Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
Hide Description

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.

Time Frame During the 28-day post-vaccination period
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Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
Arm/Group Title Vaxigrip Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 43
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE(s)
0
   0.0%
Related SAE(s)
0
   0.0%
18.Secondary Outcome
Title Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
Hide Description

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.

This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.

Time Frame During the 6-month safety follow up after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.
Arm/Group Title Vaxigrip Group
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 43
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE(s)
0
   0.0%
Related SAE(s)
0
   0.0%
Time Frame Serious adverse events were assessed during the 28 day post vaccination period and the 6-month safety follow-up period. Systematically and non-systematically assessed frequent adverse events were assessed during 4 day and 28 day post vaccination periods.
Adverse Event Reporting Description For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
 
Arm/Group Title Fluviral F1 Group Fluviral F2 Group Vaxigrip Group
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Fluviral F1 Group Fluviral F2 Group Vaxigrip Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fluviral F1 Group Fluviral F2 Group Vaxigrip Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/164 (1.22%)   2/167 (1.20%)   0/43 (0.00%) 
Infections and infestations       
Pneumonia * [1]  1/164 (0.61%)  0/167 (0.00%)  0/43 (0.00%) 
Lobar pneumonia * [2]  1/164 (0.61%)  0/167 (0.00%)  0/43 (0.00%) 
Viral pharyngitis * [2]  0/164 (0.00%)  1/167 (0.60%)  0/43 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Bronchial hyperreactivity * [1]  0/164 (0.00%)  1/167 (0.60%)  0/43 (0.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
SAE was assessed within the 28-day post vaccination period.
[2]
SAE was assessed through the 6-month safety follow-up period.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fluviral F1 Group Fluviral F2 Group Vaxigrip Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   129/164 (78.66%)   138/167 (82.63%)   34/43 (79.07%) 
Gastrointestinal disorders       
Diarrhoea *  8/164 (4.88%)  9/167 (5.39%)  6/43 (13.95%) 
Teething *  11/164 (6.71%)  10/167 (5.99%)  4/43 (9.30%) 
Vomiting *  13/164 (7.93%)  16/167 (9.58%)  3/43 (6.98%) 
General disorders       
Pain   45/161 (27.95%)  55/164 (33.54%)  17/43 (39.53%) 
Redness   49/161 (30.43%)  54/164 (32.93%)  13/43 (30.23%) 
Swelling   22/161 (13.66%)  24/164 (14.63%)  5/43 (11.63%) 
Drowsiness   54/161 (33.54%)  65/163 (39.88%)  16/43 (37.21%) 
Irritability   81/161 (50.31%)  83/163 (50.92%)  22/43 (51.16%) 
Loss of appetite   50/161 (31.06%)  54/163 (33.13%)  14/43 (32.56%) 
Fever   16/161 (9.94%)  9/163 (5.52%)  3/43 (6.98%) 
Pyrexia *  19/164 (11.59%)  15/167 (8.98%)  5/43 (11.63%) 
Infections and infestations       
Nasopharyngitis *  14/164 (8.54%)  18/167 (10.78%)  4/43 (9.30%) 
Upper respiratory tract infection *  29/164 (17.68%)  16/167 (9.58%)  2/43 (4.65%) 
Respiratory, thoracic and mediastinal disorders       
Cough *  18/164 (10.98%)  24/167 (14.37%)  3/43 (6.98%) 
Rhinorrhoea *  8/164 (4.88%)  9/167 (5.39%)  2/43 (4.65%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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