Trial Outcomes & Findings for Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children (NCT NCT00764790)
NCT ID: NCT00764790
Last Updated: 2018-07-31
Results Overview
GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine. Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3317 participants
Primary outcome timeframe
Day 0 (PRE), Day 28 or Day 56 (POST)
Results posted on
2018-07-31
Participant Flow
Participant milestones
| Measure |
Fluarix Dose A Group
Subjects were administered 1 or 2 doses\* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluarix Dose B Group
Subjects were administered 1 or 2 doses\*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluzone Group
Subjects were administered 1 or 2 doses\* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1107
|
1106
|
1104
|
|
Overall Study
COMPLETED
|
1069
|
1065
|
1074
|
|
Overall Study
NOT COMPLETED
|
38
|
41
|
30
|
Reasons for withdrawal
| Measure |
Fluarix Dose A Group
Subjects were administered 1 or 2 doses\* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluarix Dose B Group
Subjects were administered 1 or 2 doses\*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluzone Group
Subjects were administered 1 or 2 doses\* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
10
|
12
|
6
|
|
Overall Study
Lost to Follow-up
|
28
|
29
|
23
|
Baseline Characteristics
Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children
Baseline characteristics by cohort
| Measure |
Fluarix Dose A Group
n=1107 Participants
Subjects were administered 1 or 2 doses\* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluarix Dose B Group
n=1106 Participants
Subjects were administered 1 or 2 doses\*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluzone Group
n=1104 Participants
Subjects were administered 1 or 2 doses\* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Total
n=3317 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
20.9 months
STANDARD_DEVIATION 8.07 • n=5 Participants
|
20.9 months
STANDARD_DEVIATION 8.42 • n=7 Participants
|
21.0 months
STANDARD_DEVIATION 8.23 • n=5 Participants
|
20.9 months
STANDARD_DEVIATION 8.24 • n=4 Participants
|
|
Sex: Female, Male
Female
|
539 Participants
n=5 Participants
|
517 Participants
n=7 Participants
|
560 Participants
n=5 Participants
|
1616 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
568 Participants
n=5 Participants
|
589 Participants
n=7 Participants
|
544 Participants
n=5 Participants
|
1701 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 0 (PRE), Day 28 or Day 56 (POST)Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine. Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
Outcome measures
| Measure |
Fluarix Dose A Group
n=1018 Participants
Subjects were administered 1 or 2 doses\* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluarix Dose B Group
n=1016 Participants
Subjects were administered 1 or 2 doses\*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluzone Group
n=1031 Participants
Subjects were administered 1 or 2 doses\* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
|---|---|---|---|
|
Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains
A/Brisbane (PRE)
|
10.4 titre
Interval 9.7 to 11.1
|
10.6 titre
Interval 9.8 to 11.4
|
10.9 titre
Interval 10.1 to 11.7
|
|
Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains
A/Brisbane (POST)
|
106.1 titre
Interval 93.8 to 120.1
|
131.6 titre
Interval 116.3 to 148.9
|
232.4 titre
Interval 214.0 to 252.3
|
|
Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains
A/Uruguay (PRE)
|
12.1 titre
Interval 11.1 to 13.2
|
11.2 titre
Interval 10.2 to 12.2
|
11.6 titre
Interval 10.7 to 12.7
|
|
Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains
A/Uruguay (POST)
|
125.6 titre
Interval 113.3 to 139.3
|
158.7 titre
Interval 143.9 to 175.2
|
280.3 titre
Interval 260.3 to 301.9
|
|
Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains
B/Florida (PRE)
|
8.4 titre
Interval 7.9 to 9.0
|
8.9 titre
Interval 8.3 to 9.6
|
8.3 titre
Interval 7.7 to 8.8
|
|
Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains
B/Florida (POST)
|
113.0 titre
Interval 103.4 to 123.4
|
164.4 titre
Interval 150.2 to 180.1
|
176.4 titre
Interval 162.3 to 191.7
|
PRIMARY outcome
Timeframe: Day 28 or Day 56Population: Analysis was performed on the ATP cohort for analysis of immunogenicity
Seroconversion is defined as the number of subjects with either a pre-vaccination anti-HA titer \< 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer. Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
Outcome measures
| Measure |
Fluarix Dose A Group
n=1017 Participants
Subjects were administered 1 or 2 doses\* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluarix Dose B Group
n=1013 Participants
Subjects were administered 1 or 2 doses\*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluzone Group
n=1030 Participants
Subjects were administered 1 or 2 doses\* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
|---|---|---|---|
|
Number of Subjects Who Seroconverted
A/Brisbane
|
636 Participants
|
699 Participants
|
929 Participants
|
|
Number of Subjects Who Seroconverted
A/Uruguay
|
747 Participants
|
808 Participants
|
988 Participants
|
|
Number of Subjects Who Seroconverted
B/Florida
|
812 Participants
|
864 Participants
|
904 Participants
|
SECONDARY outcome
Timeframe: Day 0 (PRE), Day 28 or Day 56 (POST)Population: Analysis was performed on the ATP cohort for analysis of immunogenicity
A seroprotected subject is a subject with a serum anti-HA titer ≥ 1:40 Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
Outcome measures
| Measure |
Fluarix Dose A Group
n=1018 Participants
Subjects were administered 1 or 2 doses\* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluarix Dose B Group
n=1016 Participants
Subjects were administered 1 or 2 doses\*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluzone Group
n=1031 Participants
Subjects were administered 1 or 2 doses\* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
|---|---|---|---|
|
Number of Seroprotected Subjects
A/Brisbane (PRE)
|
185 Participants
|
186 Participants
|
206 Participants
|
|
Number of Seroprotected Subjects
A/Brisbane (POST)
|
699 Participants
|
754 Participants
|
986 Participants
|
|
Number of Seroprotected Subjects
A/Uruguay (PRE)
|
222 Participants
|
193 Participants
|
214 Participants
|
|
Number of Seroprotected Subjects
A/Uruguay (POST)
|
788 Participants
|
846 Participants
|
1012 Participants
|
|
Number of Seroprotected Subjects
B/Florida (PRE)
|
171 Participants
|
181 Participants
|
166 Participants
|
|
Number of Seroprotected Subjects
B/Florida (POST)
|
872 Participants
|
902 Participants
|
935 Participants
|
SECONDARY outcome
Timeframe: Day 28 or Day 56Population: Analysis was performed on the ATP cohort for analysis of immunogenicity
Seroconversion factor is defined as the fold increase in serum anti-HA GMTs post-vaccination (Day 28 or 56) compared to pre-vaccination (Day 0). Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
Outcome measures
| Measure |
Fluarix Dose A Group
n=1017 Participants
Subjects were administered 1 or 2 doses\* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluarix Dose B Group
n=1013 Participants
Subjects were administered 1 or 2 doses\*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluzone Group
n=1030 Participants
Subjects were administered 1 or 2 doses\* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
|---|---|---|---|
|
Seroconversion Factor
A/Brisbane
|
10.2 fold increase
Interval 9.2 to 11.4
|
12.4 fold increase
Interval 11.2 to 13.7
|
21.4 fold increase
Interval 19.9 to 23.1
|
|
Seroconversion Factor
A/Uruguay
|
10.4 fold increase
Interval 9.6 to 11.3
|
14.2 fold increase
Interval 13.1 to 15.4
|
24.1 fold increase
Interval 22.6 to 25.7
|
|
Seroconversion Factor
B/Florida
|
13.4 fold increase
Interval 12.4 to 14.5
|
18.4 fold increase
Interval 17.0 to 20.0
|
21.4 fold increase
Interval 19.7 to 23.1
|
SECONDARY outcome
Timeframe: During a 4-day follow-up period after vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects for whom data were available.
Solicited local symptoms assessed include pain, redness and swelling.
Outcome measures
| Measure |
Fluarix Dose A Group
n=1081 Participants
Subjects were administered 1 or 2 doses\* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluarix Dose B Group
n=1086 Participants
Subjects were administered 1 or 2 doses\*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluzone Group
n=1090 Participants
Subjects were administered 1 or 2 doses\* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
|---|---|---|---|
|
Number of Subjects Reporting Solicited Local Symptoms
Pain
|
403 Participants
|
406 Participants
|
363 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Redness
|
259 Participants
|
249 Participants
|
253 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Swelling
|
152 Participants
|
170 Participants
|
129 Participants
|
SECONDARY outcome
Timeframe: During a 4-day follow-up period after vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, including all vaccinated subjects for whom data were available.
Solicited general symptoms assessed include drowsiness, irritability, loss of appetitie, and temperature.
Outcome measures
| Measure |
Fluarix Dose A Group
n=1080 Participants
Subjects were administered 1 or 2 doses\* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluarix Dose B Group
n=1086 Participants
Subjects were administered 1 or 2 doses\*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluzone Group
n=1090 Participants
Subjects were administered 1 or 2 doses\* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
|---|---|---|---|
|
Number of Subjects Reporting Solicited General Symptoms
Drowsiness
|
293 Participants
|
317 Participants
|
298 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Irritability
|
386 Participants
|
387 Participants
|
375 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Loss of appetite
|
281 Participants
|
273 Participants
|
270 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Temperature
|
67 Participants
|
69 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: During a 28-day follow-up period after vaccinationAn AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Outcome measures
| Measure |
Fluarix Dose A Group
n=1107 Participants
Subjects were administered 1 or 2 doses\* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluarix Dose B Group
n=1106 Participants
Subjects were administered 1 or 2 doses\*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluzone Group
n=1104 Participants
Subjects were administered 1 or 2 doses\* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
|---|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AE)
|
565 Participants
|
541 Participants
|
562 Participants
|
SECONDARY outcome
Timeframe: During the entire study (Day 0 until Month 6)An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above. NOCDs assessed include for example: diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders
Outcome measures
| Measure |
Fluarix Dose A Group
n=1107 Participants
Subjects were administered 1 or 2 doses\* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluarix Dose B Group
n=1106 Participants
Subjects were administered 1 or 2 doses\*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluzone Group
n=1104 Participants
Subjects were administered 1 or 2 doses\* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAE) and New Onset of Chronic Diseases (NOCD)
SAE
|
35 Participants
|
29 Participants
|
31 Participants
|
|
Number of Subjects Reporting Serious Adverse Events (SAE) and New Onset of Chronic Diseases (NOCD)
NOCD
|
10 Participants
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: During the entire study (Day 0 until Month 6)Rare serious events have an occurrence rate of 1/300 (0.3%).
Outcome measures
| Measure |
Fluarix Dose A Group
n=1107 Participants
Subjects were administered 1 or 2 doses\* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluarix Dose B Group
n=1106 Participants
Subjects were administered 1 or 2 doses\*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluzone Group
n=1104 Participants
Subjects were administered 1 or 2 doses\* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
|---|---|---|---|
|
Number of Subjects Reporting Rare Serious Events
Pneumonia
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects Reporting Rare Serious Events
Bronchiolitis
|
0 Participants
|
3 Participants
|
3 Participants
|
Adverse Events
Fluarix Dose A Group
Serious events: 35 serious events
Other events: 805 other events
Deaths: 0 deaths
Fluarix Dose B Group
Serious events: 29 serious events
Other events: 791 other events
Deaths: 0 deaths
Fluzone Group
Serious events: 31 serious events
Other events: 808 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluarix Dose A Group
n=1107 participants at risk
Subjects were administered 1 or 2 doses\* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluarix Dose B Group
n=1106 participants at risk
Subjects were administered 1 or 2 doses\*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluzone Group
n=1104 participants at risk
Subjects were administered 1 or 2 doses\* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
|---|---|---|---|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/1107
|
0.00%
0/1106
|
0.09%
1/1104
|
|
Infections and infestations
Acute tonsillitis
|
0.09%
1/1107
|
0.00%
0/1106
|
0.00%
0/1104
|
|
General disorders
Adverse drug reaction
|
0.09%
1/1107
|
0.00%
0/1106
|
0.00%
0/1104
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/1107
|
0.09%
1/1106
|
0.00%
0/1104
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.18%
2/1107
|
0.09%
1/1106
|
0.18%
2/1104
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.09%
1/1107
|
0.00%
0/1106
|
0.00%
0/1104
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.09%
1/1107
|
0.00%
0/1106
|
0.00%
0/1104
|
|
Infections and infestations
Bronchiolitis
|
0.36%
4/1107
|
0.27%
3/1106
|
0.27%
3/1104
|
|
Infections and infestations
Bronchitis
|
0.09%
1/1107
|
0.18%
2/1106
|
0.09%
1/1104
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/1107
|
0.09%
1/1106
|
0.09%
1/1104
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/1107
|
0.00%
0/1106
|
0.09%
1/1104
|
|
Congenital, familial and genetic disorders
Coarctation of the aorta
|
0.09%
1/1107
|
0.00%
0/1106
|
0.00%
0/1104
|
|
Injury, poisoning and procedural complications
Concussion
|
0.09%
1/1107
|
0.00%
0/1106
|
0.00%
0/1104
|
|
Nervous system disorders
Convulsion
|
0.00%
0/1107
|
0.09%
1/1106
|
0.00%
0/1104
|
|
Infections and infestations
Croup infectious
|
0.09%
1/1107
|
0.09%
1/1106
|
0.00%
0/1104
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/1107
|
0.09%
1/1106
|
0.00%
0/1104
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1107
|
0.00%
0/1106
|
0.09%
1/1104
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/1107
|
0.00%
0/1106
|
0.09%
1/1104
|
|
Injury, poisoning and procedural complications
Electric shock
|
0.00%
0/1107
|
0.00%
0/1106
|
0.09%
1/1104
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/1107
|
0.09%
1/1106
|
0.00%
0/1104
|
|
Injury, poisoning and procedural complications
Fall
|
0.09%
1/1107
|
0.00%
0/1106
|
0.00%
0/1104
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/1107
|
0.09%
1/1106
|
0.00%
0/1104
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.09%
1/1107
|
0.00%
0/1106
|
0.00%
0/1104
|
|
Injury, poisoning and procedural complications
Foreign body trauma
|
0.00%
0/1107
|
0.00%
0/1106
|
0.09%
1/1104
|
|
Gastrointestinal disorders
Gastritis
|
0.18%
2/1107
|
0.00%
0/1106
|
0.00%
0/1104
|
|
Infections and infestations
Gastroenteritis
|
0.54%
6/1107
|
0.36%
4/1106
|
0.18%
2/1104
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/1107
|
0.09%
1/1106
|
0.00%
0/1104
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.18%
2/1107
|
0.00%
0/1106
|
0.36%
4/1104
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/1107
|
0.00%
0/1106
|
0.09%
1/1104
|
|
Injury, poisoning and procedural complications
Head injury
|
0.09%
1/1107
|
0.09%
1/1106
|
0.00%
0/1104
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/1107
|
0.00%
0/1106
|
0.09%
1/1104
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1107
|
0.09%
1/1106
|
0.00%
0/1104
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1107
|
0.00%
0/1106
|
0.09%
1/1104
|
|
Skin and subcutaneous tissue disorders
Idiopathic urticaria
|
0.00%
0/1107
|
0.00%
0/1106
|
0.09%
1/1104
|
|
Infections and infestations
Influenza
|
0.09%
1/1107
|
0.00%
0/1106
|
0.00%
0/1104
|
|
Injury, poisoning and procedural complications
Injury corneal
|
0.00%
0/1107
|
0.00%
0/1106
|
0.09%
1/1104
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/1107
|
0.18%
2/1106
|
0.00%
0/1104
|
|
Infections and infestations
Lobar pneumonia
|
0.09%
1/1107
|
0.00%
0/1106
|
0.00%
0/1104
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/1107
|
0.00%
0/1106
|
0.09%
1/1104
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1107
|
0.09%
1/1106
|
0.00%
0/1104
|
|
Infections and infestations
Oral herpes
|
0.09%
1/1107
|
0.00%
0/1106
|
0.00%
0/1104
|
|
Infections and infestations
Otitis media
|
0.09%
1/1107
|
0.00%
0/1106
|
0.09%
1/1104
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/1107
|
0.00%
0/1106
|
0.18%
2/1104
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/1107
|
0.09%
1/1106
|
0.00%
0/1104
|
|
Infections and infestations
Pharyngitis
|
0.09%
1/1107
|
0.00%
0/1106
|
0.00%
0/1104
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/1107
|
0.09%
1/1106
|
0.00%
0/1104
|
|
Infections and infestations
Pneumonia
|
0.36%
4/1107
|
0.36%
4/1106
|
0.27%
3/1104
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/1107
|
0.09%
1/1106
|
0.00%
0/1104
|
|
Infections and infestations
Pneumonia primary atypical
|
0.09%
1/1107
|
0.00%
0/1106
|
0.00%
0/1104
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/1107
|
0.00%
0/1106
|
0.09%
1/1104
|
|
Infections and infestations
Pneumonia viral
|
0.09%
1/1107
|
0.09%
1/1106
|
0.00%
0/1104
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.09%
1/1107
|
0.00%
0/1106
|
0.00%
0/1104
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/1107
|
0.00%
0/1106
|
0.18%
2/1104
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/1107
|
0.00%
0/1106
|
0.09%
1/1104
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.18%
2/1107
|
0.00%
0/1106
|
0.00%
0/1104
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/1107
|
0.00%
0/1106
|
0.18%
2/1104
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1107
|
0.09%
1/1106
|
0.00%
0/1104
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/1107
|
0.09%
1/1106
|
0.00%
0/1104
|
|
Infections and infestations
Upper respiratory tract infection
|
0.63%
7/1107
|
0.36%
4/1106
|
0.36%
4/1104
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1107
|
0.09%
1/1106
|
0.00%
0/1104
|
|
Infections and infestations
Viral rash
|
0.00%
0/1107
|
0.00%
0/1106
|
0.18%
2/1104
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/1107
|
0.00%
0/1106
|
0.09%
1/1104
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1107
|
0.00%
0/1106
|
0.09%
1/1104
|
Other adverse events
| Measure |
Fluarix Dose A Group
n=1107 participants at risk
Subjects were administered 1 or 2 doses\* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluarix Dose B Group
n=1106 participants at risk
Subjects were administered 1 or 2 doses\*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
Fluzone Group
n=1104 participants at risk
Subjects were administered 1 or 2 doses\* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age).
\* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
12.2%
135/1107
|
10.5%
116/1106
|
12.6%
139/1104
|
|
Infections and infestations
Nasopharyngitis
|
12.6%
139/1107
|
10.8%
119/1106
|
11.1%
123/1104
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
59/1107
|
6.3%
70/1106
|
5.4%
60/1104
|
|
General disorders
Pyrexia
|
4.8%
53/1107
|
4.7%
52/1106
|
5.6%
62/1104
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
62/1107
|
3.8%
42/1106
|
5.4%
60/1104
|
|
Infections and infestations
Pharyngitis
|
4.4%
49/1107
|
5.4%
60/1106
|
4.7%
52/1104
|
|
General disorders
Pain
|
36.4%
403/1107
|
36.7%
406/1106
|
32.9%
363/1104
|
|
General disorders
Redness
|
23.4%
259/1107
|
22.5%
249/1106
|
22.9%
253/1104
|
|
General disorders
Swelling
|
13.7%
152/1107
|
15.4%
170/1106
|
11.7%
129/1104
|
|
General disorders
Drowsiness
|
26.5%
293/1107
|
28.7%
317/1106
|
27.0%
298/1104
|
|
General disorders
Irritability
|
34.9%
386/1107
|
35.0%
387/1106
|
34.0%
375/1104
|
|
General disorders
Loss of appetite
|
25.4%
281/1107
|
24.7%
273/1106
|
24.5%
270/1104
|
|
General disorders
Temperature
|
6.1%
67/1107
|
6.2%
69/1106
|
6.5%
72/1104
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER