Trial Outcomes & Findings for Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children (NCT NCT00980005)
NCT ID: NCT00980005
Last Updated: 2018-09-21
Results Overview
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2116 participants
Primary outcome timeframe
At Day 0 and 28 after last vaccine dose.
Results posted on
2018-09-21
Participant Flow
Subjects were stratified by age-strata: 3-4, 5-8 and 9-17 years and received vaccine according to their priming status: primed subjects received a 2-dose priming immunization in a previous season, whereas unprimed subjects had not. Blood samples: at Days 0 - 28 for primed subjects and subjects 9-17 years and at Days 0-56 for unprimed subjects.
Participant milestones
| Measure |
Flulaval Group
subjects received Flulaval™ vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
|
Fluzone Group
subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
|
|---|---|---|
|
Overall Study
STARTED
|
1055
|
1061
|
|
Overall Study
COMPLETED
|
1008
|
998
|
|
Overall Study
NOT COMPLETED
|
47
|
63
|
Reasons for withdrawal
| Measure |
Flulaval Group
subjects received Flulaval™ vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
|
Fluzone Group
subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
17
|
|
Overall Study
Lost to Follow-up
|
37
|
43
|
|
Overall Study
Other
|
4
|
3
|
Baseline Characteristics
Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children
Baseline characteristics by cohort
| Measure |
Flulaval Group
n=1055 Participants
subjects received Flulaval™ vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
|
Fluzone Group
n=1061 Participants
subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
|
Total
n=2116 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.8 Years
STANDARD_DEVIATION 4.18 • n=5 Participants
|
7.8 Years
STANDARD_DEVIATION 4.10 • n=7 Participants
|
7.8 Years
STANDARD_DEVIATION 4.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
500 Participants
n=5 Participants
|
496 Participants
n=7 Participants
|
996 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
555 Participants
n=5 Participants
|
565 Participants
n=7 Participants
|
1120 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Day 0 and 28 after last vaccine dose.Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs).
Outcome measures
| Measure |
Flulaval Group
n=987 Participants
subjects received Flulaval™ vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
|
Fluzone Group
n=979 Participants
subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
|
Flulaval Less Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
|
Fluzone Les Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age
|
|---|---|---|---|---|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.
A/Brisbane [at Day 0]
|
46.0 Titers
Interval 41.9 to 50.4
|
45.8 Titers
Interval 41.8 to 50.2
|
—
|
—
|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.
A/Brisbane [at Day 28]
|
320.9 Titers
Interval 298.3 to 345.2
|
329.4 Titers
Interval 306.8 to 353.7
|
—
|
—
|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.
A/Uruguay [at Day 0]
|
57.1 Titers
Interval 51.8 to 63.0
|
63.9 Titers
Interval 58.1 to 70.3
|
—
|
—
|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.
A/Uruguay [at Day 28]
|
414.7 Titers
Interval 386.5 to 444.9
|
451.9 Titers
Interval 423.8 to 481.8
|
—
|
—
|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.
B/Brisbane [at Day 0]
|
16.6 Titers
Interval 15.3 to 18.1
|
16.8 Titers
Interval 15.4 to 18.3
|
—
|
—
|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.
B/Brisbane [at Day 28]
|
213.7 Titers
Interval 198.5 to 230.1
|
200.2 Titers
Interval 186.1 to 215.3
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 28 after last vaccine dose.Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) 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.
Outcome measures
| Measure |
Flulaval Group
n=987 Participants
subjects received Flulaval™ vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
|
Fluzone Group
n=978 Participants
subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
|
Flulaval Less Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
|
Fluzone Les Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age
|
|---|---|---|---|---|
|
Number of Seroconverted Subjects for HI Antibodies Against the Three Strains.
A/Brisbane
|
590 Participants
|
569 Participants
|
—
|
—
|
|
Number of Seroconverted Subjects for HI Antibodies Against the Three Strains.
A/Uruguay
|
673 Participants
|
647 Participants
|
—
|
—
|
|
Number of Seroconverted Subjects for HI Antibodies Against the Three Strains.
B/Brisbane
|
800 Participants
|
769 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 and 28 after last vaccine dose.Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs). Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
Outcome measures
| Measure |
Flulaval Group
n=987 Participants
subjects received Flulaval™ vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
|
Fluzone Group
n=979 Participants
subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
|
Flulaval Less Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
|
Fluzone Les Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age
|
|---|---|---|---|---|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
B/Brisbane at Day 28 [3-4 years]
|
174.1 Titers
Interval 149.8 to 202.5
|
148.5 Titers
Interval 129.4 to 170.4
|
—
|
—
|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
A/Brisbane at Day 0 [3-4 years]
|
38.4 Titers
Interval 31.5 to 46.7
|
34.4 Titers
Interval 28.4 to 41.7
|
—
|
—
|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
A/Brisbane at Day 28 [3-4 years]
|
263.5 Titers
Interval 229.3 to 302.9
|
281.9 Titers
Interval 246.3 to 322.7
|
—
|
—
|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
A/Brisbane at Day 0 [5-8 years]
|
40.2 Titers
Interval 34.8 to 46.5
|
41.4 Titers
Interval 35.7 to 48.1
|
—
|
—
|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
A/Brisbane at Day 28 [5-8 years]
|
251.8 Titers
Interval 222.3 to 285.3
|
251.5 Titers
Interval 223.8 to 282.7
|
—
|
—
|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
A/Brisbane at Day 0 [9-17 years]
|
60.2 Titers
Interval 52.0 to 69.6
|
61.9 Titers
Interval 53.7 to 71.2
|
—
|
—
|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
A/Brisbane at Day 28 [9-17 years]
|
473.6 Titers
Interval 425.1 to 527.5
|
478.2 Titers
Interval 428.2 to 534.0
|
—
|
—
|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
A/Uruguay at Day 0 [3-4 years]
|
38.7 Titers
Interval 31.7 to 47.2
|
50.2 Titers
Interval 40.7 to 61.8
|
—
|
—
|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
A/Uruguay at Day 28 [3-4 years]
|
322.8 Titers
Interval 276.9 to 376.3
|
418.3 Titers
Interval 366.9 to 477.0
|
—
|
—
|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
A/Uruguay at Day 0 [5-8 years]
|
78.5 Titers
Interval 66.9 to 92.1
|
78.1 Titers
Interval 67.0 to 91.2
|
—
|
—
|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
A/Uruguay at Day 28 [5-8 years]
|
476.3 Titers
Interval 426.3 to 532.1
|
494.2 Titers
Interval 442.4 to 552.1
|
—
|
—
|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
A/Uruguay at Day 0 [9-17 years]
|
56.3 Titers
Interval 48.7 to 65.2
|
62.6 Titers
Interval 54.1 to 72.3
|
—
|
—
|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
A/Uruguay at Day 28 [9-17 years]
|
438.4 Titers
Interval 394.1 to 487.6
|
437.8 Titers
Interval 397.4 to 482.3
|
—
|
—
|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
B/Brisbane at Day 0 [3-4 years]
|
13.1 Titers
Interval 11.2 to 15.3
|
11.6 Titers
Interval 10.0 to 13.5
|
—
|
—
|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
B/Brisbane at Day 0 [5-8 years]
|
16.2 Titers
Interval 14.1 to 18.7
|
16.9 Titers
Interval 14.7 to 19.5
|
—
|
—
|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
B/Brisbane at Day 28 [5-8 years]
|
196.8 Titers
Interval 175.1 to 221.1
|
202.8 Titers
Interval 179.0 to 229.7
|
—
|
—
|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
B/Brisbane at Day 0 [9-17 years]
|
20.5 Titers
Interval 17.9 to 23.6
|
21.7 Titers
Interval 18.9 to 24.9
|
—
|
—
|
|
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
B/Brisbane at Day 28 [9-17 years]
|
271.1 Titers
Interval 240.8 to 305.1
|
244.6 Titers
Interval 217.9 to 274.5
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 28 after last vaccine dose.Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) 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. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
Outcome measures
| Measure |
Flulaval Group
n=987 Participants
subjects received Flulaval™ vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
|
Fluzone Group
n=978 Participants
subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
|
Flulaval Less Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
|
Fluzone Les Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age
|
|---|---|---|---|---|
|
Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Brisbane [3-4 years]
|
161 Participants
|
177 Participants
|
—
|
—
|
|
Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Brisbane [5-8 years]
|
211 Participants
|
191 Participants
|
—
|
—
|
|
Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Brisbane [9-17 years]
|
218 Participants
|
201 Participants
|
—
|
—
|
|
Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Uruguay [3-4 years]
|
203 Participants
|
190 Participants
|
—
|
—
|
|
Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Uruguay [5-8 years]
|
233 Participants
|
228 Participants
|
—
|
—
|
|
Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Uruguay [9-17 years]
|
237 Participants
|
229 Participants
|
—
|
—
|
|
Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
B/Brisbane [3-4 years]
|
227 Participants
|
214 Participants
|
—
|
—
|
|
Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
B/Brisbane [5-8 years]
|
289 Participants
|
293 Participants
|
—
|
—
|
|
Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
B/Brisbane [9-17 years]
|
284 Participants
|
262 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 and 28 after last vaccine dose.Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults.
Outcome measures
| Measure |
Flulaval Group
n=987 Participants
subjects received Flulaval™ vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
|
Fluzone Group
n=979 Participants
subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
|
Flulaval Less Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
|
Fluzone Les Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age
|
|---|---|---|---|---|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.
B/Brisbane [at Day 28]
|
936 Participants
|
925 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.
A/Brisbane [at Day 0]
|
640 Participants
|
639 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.
A/Brisbane [at Day 28]
|
969 Participants
|
965 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.
A/Uruguay [at Day 0]
|
676 Participants
|
690 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.
A/Uruguay [at Day 28]
|
970 Participants
|
973 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.
B/Brisbane [at Day 0]
|
359 Participants
|
360 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 and 28 after last vaccine dose.Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
Outcome measures
| Measure |
Flulaval Group
n=987 Participants
subjects received Flulaval™ vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
|
Fluzone Group
n=979 Participants
subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
|
Flulaval Less Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
|
Fluzone Les Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age
|
|---|---|---|---|---|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Brisbane at Day 0 [3-4 years]
|
155 Participants
|
145 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Brisbane at Day 28 [3-4 years]
|
265 Participants
|
258 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Brisbane at Day 0 [5-8 years]
|
227 Participants
|
228 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Brisbane at Day 28 [5-8 years]
|
347 Participants
|
346 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Brisbane at Day 0 [9-17 years]
|
258 Participants
|
266 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Brisbane at Day 28 [9-17 years]
|
357 Participants
|
361 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Uruguay at Day 0 [3-4 years]
|
153 Participants
|
158 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Uruguay at Day 28 [3-4 years]
|
265 Participants
|
259 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Uruguay at Day 0 [5-8 years]
|
267 Participants
|
269 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Uruguay at Day 28 [5-8 years]
|
349 Participants
|
351 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Uruguay at Day 0 [9-17 years]
|
256 Participants
|
263 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Uruguay at Day 28 [9-17 years] )
|
356 Participants
|
363 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
B/Brisbane at Day 0 [3-4 years]
|
80 Participants
|
68 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
B/Brisbane at Day 28 [3-4 years]
|
254 Participants
|
239 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
B/Brisbane at Day 0 [5-8 years]
|
127 Participants
|
127 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
B/Brisbane at Day 28 [5-8 years]
|
334 Participants
|
335 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
B/Brisbane at Day 0 [9-17 years]
|
152 Participants
|
165 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
B/Brisbane at Day 28 [9-17 years]
|
348 Participants
|
351 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 and at Day 28 after last vaccine dosePopulation: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen.
Outcome measures
| Measure |
Flulaval Group
n=987 Participants
subjects received Flulaval™ vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
|
Fluzone Group
n=978 Participants
subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
|
Flulaval Less Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
|
Fluzone Les Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age
|
|---|---|---|---|---|
|
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains.
A/Brisbane
|
7.0 Fold change
Interval 6.3 to 7.7
|
7.2 Fold change
Interval 6.5 to 8.0
|
—
|
—
|
|
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains.
A/Uruguay
|
7.3 Fold change
Interval 6.7 to 7.9
|
7.1 Fold change
Interval 6.5 to 7.7
|
—
|
—
|
|
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains.
B/Brisbane
|
12.8 Fold change
Interval 11.8 to 14.0
|
11.9 Fold change
Interval 10.9 to 13.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 and at Day 28 after last vaccine dosePopulation: The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination.
The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
Outcome measures
| Measure |
Flulaval Group
n=987 Participants
subjects received Flulaval™ vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
|
Fluzone Group
n=978 Participants
subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
|
Flulaval Less Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
|
Fluzone Les Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age
|
|---|---|---|---|---|
|
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Brisbane [3-4 years]
|
6.9 Fold change
Interval 5.7 to 8.2
|
8.2 Fold change
Interval 6.8 to 9.8
|
—
|
—
|
|
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Brisbane [5-8 years]
|
6.3 Fold change
Interval 5.4 to 7.3
|
6.1 Fold change
Interval 5.2 to 7.1
|
—
|
—
|
|
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Brisbane [9-17 years]
|
7.9 Fold change
Interval 6.7 to 9.3
|
7.7 Fold change
Interval 6.5 to 9.2
|
—
|
—
|
|
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Uruguay [3-4 years]
|
8.4 Fold change
Interval 7.2 to 9.7
|
8.3 Fold change
Interval 7.1 to 9.9
|
—
|
—
|
|
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Uruguay [5-8 years]
|
6.1 Fold change
Interval 5.3 to 6.9
|
6.3 Fold change
Interval 5.5 to 7.2
|
—
|
—
|
|
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.
A/Uruguay [9-17 years]
|
7.8 Fold change
Interval 6.7 to 9.0
|
7.0 Fold change
Interval 6.0 to 8.2
|
—
|
—
|
|
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.
B/Brisbane [3-4 years]
|
13.3 Fold change
Interval 11.5 to 15.4
|
12.8 Fold change
Interval 11.0 to 14.8
|
—
|
—
|
|
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.
B/Brisbane [5-8 years]
|
12.2 Fold change
Interval 10.7 to 13.8
|
12.0 Fold change
Interval 10.5 to 13.7
|
—
|
—
|
|
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.
B/Brisbane [9-17 years]
|
13.2 Fold change
Interval 11.3 to 15.4
|
11.3 Fold change
Interval 9.6 to 13.2
|
—
|
—
|
SECONDARY outcome
Timeframe: During a 4-day follow-up period (Days 0-3) after vaccination.Population: The Total Vaccinated cohort included all vaccinated subjects.
The general symptoms solicited from study subjects younger than 5 years of age were drowsiness, irritability, loss of appetite, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness, irritability = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C. Related = symptom assessed by the investigator as causally related to the vaccination.
Outcome measures
| Measure |
Flulaval Group
subjects received Flulaval™ vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
|
Fluzone Group
subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
|
Flulaval Less Than 5 Years Old Group
n=293 Participants
Subjects below 5 years of age and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
|
Fluzone Les Than 5 Years Old Group
n=279 Participants
Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age
|
|---|---|---|---|---|
|
Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Any drowsiness
|
—
|
—
|
61 Participants
|
63 Participants
|
|
Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Grade 3 drowsiness
|
—
|
—
|
4 Participants
|
2 Participants
|
|
Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Drowsiness related to vaccination
|
—
|
—
|
57 Participants
|
56 Participants
|
|
Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Any irritability
|
—
|
—
|
86 Participants
|
87 Participants
|
|
Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Grade 3 irritability
|
—
|
—
|
6 Participants
|
4 Participants
|
|
Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Irritability related to vaccination
|
—
|
—
|
81 Participants
|
81 Participants
|
|
Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Any loss of appetite
|
—
|
—
|
52 Participants
|
47 Participants
|
|
Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Grade 3 loss of appetite
|
—
|
—
|
7 Participants
|
2 Participants
|
|
Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Loss of appetite related to vaccination
|
—
|
—
|
45 Participants
|
42 Participants
|
|
Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Fever >= 38.0°C
|
—
|
—
|
15 Participants
|
10 Participants
|
|
Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Fever >= 39.0°C - <= 40.0°C
|
—
|
—
|
3 Participants
|
2 Participants
|
|
Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Fever related to vaccination
|
—
|
—
|
14 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: During a 4-day follow-up period (Days 0-3) after vaccination.Population: The Total Vaccinated cohort included all vaccinated subjects.
The general symptoms solicited from study subjects 5 years of age and older were arthralgia (joint pain), fatigue, headache, muscle aches, shivering, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C. Related = symptom assessed by the investigator as causaly related to the vaccination.
Outcome measures
| Measure |
Flulaval Group
subjects received Flulaval™ vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
|
Fluzone Group
subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
|
Flulaval Less Than 5 Years Old Group
n=750 Participants
Subjects below 5 years of age and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
|
Fluzone Les Than 5 Years Old Group
n=747 Participants
Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age
|
|---|---|---|---|---|
|
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Any fatigue
|
—
|
—
|
138 Participants
|
137 Participants
|
|
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Grade 3 fatigue
|
—
|
—
|
11 Participants
|
10 Participants
|
|
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Fatigue related to vaccination
|
—
|
—
|
119 Participants
|
117 Participants
|
|
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Any headache
|
—
|
—
|
141 Participants
|
131 Participants
|
|
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Grade 3 headache
|
—
|
—
|
6 Participants
|
4 Participants
|
|
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Headache related to vaccination
|
—
|
—
|
115 Participants
|
105 Participants
|
|
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Any muscle aches
|
—
|
—
|
200 Participants
|
189 Participants
|
|
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Grade 3 muscle aches
|
—
|
—
|
6 Participants
|
7 Participants
|
|
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Muscle aches related to vaccination
|
—
|
—
|
180 Participants
|
179 Participants
|
|
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Any shivering
|
—
|
—
|
45 Participants
|
40 Participants
|
|
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Grade 3 shivering
|
—
|
—
|
2 Participants
|
3 Participants
|
|
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Shivering related to vaccination
|
—
|
—
|
36 Participants
|
31 Participants
|
|
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Fever >= 38.0°C
|
—
|
—
|
36 Participants
|
36 Participants
|
|
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Fever >= 39.0°C - <= 40.0°C
|
—
|
—
|
12 Participants
|
13 Participants
|
|
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Temperature related to vaccination
|
—
|
—
|
27 Participants
|
25 Participants
|
|
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Any arthralgia
|
—
|
—
|
70 Participants
|
80 Participants
|
|
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Grade 3 arthralgia
|
—
|
—
|
2 Participants
|
2 Participants
|
|
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Arthralgia related to vaccination
|
—
|
—
|
65 Participants
|
74 Participants
|
SECONDARY outcome
Timeframe: During a 4-day follow-up period (Days 0-3) after vaccination.Population: The Total Vaccinated cohort included all vaccinated subjects.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination.
Outcome measures
| Measure |
Flulaval Group
n=1043 Participants
subjects received Flulaval™ vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
|
Fluzone Group
n=1026 Participants
subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
|
Flulaval Less Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
|
Fluzone Les Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Grade 3 pain
|
26 Participants
|
28 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Any redness
|
57 Participants
|
53 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Any swelling
|
51 Participants
|
59 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Any pain
|
615 Participants
|
584 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Grade 3 redness
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Grade 3 swelling
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: During a 4-day follow-up period (Days 0-3) after vaccination.Population: The Total Vaccinated cohort included all vaccinated subjects.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
Outcome measures
| Measure |
Flulaval Group
n=1043 Participants
subjects received Flulaval™ vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
|
Fluzone Group
n=1026 Participants
subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
|
Flulaval Less Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
|
Fluzone Les Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Any redness [5-8 years]
|
30 Participants
|
22 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Grade 3 redness [9-17 years]
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Any pain [3-4 years]
|
139 Participants
|
130 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Grade 3 pain [3-4 years]
|
5 Participants
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Any redness [3-4 years]
|
14 Participants
|
18 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Grade 3 redness [3-4 years]
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Any swelling [3-4 years]
|
9 Participants
|
11 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Grade 3 swelling [3-4 years]
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Any pain [5-8 years]
|
252 Participants
|
249 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Grade 3 pain [5-8 years]
|
16 Participants
|
18 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Grade 3 redness [5-8 years]
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Any swelling [5-8 years]
|
24 Participants
|
28 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Grade 3 swelling [5-8 years]
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Any pain [9-17 years]
|
224 Participants
|
205 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Grade 3 pain [9-17 years]
|
5 Participants
|
6 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Any redness [9-17 years]
|
13 Participants
|
13 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Any swelling [9-17 years]
|
18 Participants
|
20 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Grade 3 swelling [9-17 years]
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: During a 28 day follow-up period (Days 0-27) after vaccination.Population: The Total Vaccinated cohort included all vaccinated subjects.
Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Flulaval Group
n=1055 Participants
subjects received Flulaval™ vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
|
Fluzone Group
n=1061 Participants
subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
|
Flulaval Less Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
|
Fluzone Les Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).
Grade 3 AE(s)
|
81 Participants
|
83 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).
Any AE(s)
|
421 Participants
|
387 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).
Related AE(s)
|
65 Participants
|
57 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: During a 28 day follow-up period (Days 0-27) after vaccination.Population: The Total Vaccinated cohort included all vaccinated subjects.
Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Flulaval Group
n=1055 Participants
subjects received Flulaval™ vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
|
Fluzone Group
n=1061 Participants
subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
|
Flulaval Less Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
|
Fluzone Les Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.
Any AE(s) [5-8 years]
|
175 Participants
|
149 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.
Grade 3 AE(s) [9-17 years]
|
22 Participants
|
26 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.
Any AE(s) [3-4 years]
|
134 Participants
|
128 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.
Grade 3 AE(s) [3-4 years]
|
23 Participants
|
25 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.
Related AE(s) [3-4 years]
|
17 Participants
|
16 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.
Grade 3 AE(s) [5-8 years]
|
36 Participants
|
32 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.
Related AE(s) [5-8 years]
|
32 Participants
|
24 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.
Any AE(s) [9-17 years]
|
112 Participants
|
110 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.
Related AE(s) [9-17 years]
|
16 Participants
|
17 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (From Day 0 up to Day 180).Population: The Total Vaccinated cohort included all vaccinated subjects.
For each solicited and unsolicited symptom the subject experiences, the subject/subject's parent(s)/ Legally Acceptable Representative (LAR(s)) was asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.
Outcome measures
| Measure |
Flulaval Group
n=1055 Participants
subjects received Flulaval™ vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
|
Fluzone Group
n=1061 Participants
subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
|
Flulaval Less Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
|
Fluzone Les Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age
|
|---|---|---|---|---|
|
Number of Subjects Reporting Medically Attended Adverse Events (MAEs).
|
447 Participants
|
432 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (From Day 0 up to Day 180).Population: The Total Vaccinated cohort included all vaccinated subjects.
An SAE is defined as any untoward medical occurrence in a patient or clinical investigation subject that: results in death, is lifethreatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Outcome measures
| Measure |
Flulaval Group
n=1055 Participants
subjects received Flulaval™ vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
|
Fluzone Group
n=1061 Participants
subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
|
Flulaval Less Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
|
Fluzone Les Than 5 Years Old Group
Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur's vaccine according to their priming status and age
|
|---|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs).
|
10 Participants
|
6 Participants
|
—
|
—
|
Adverse Events
Flulaval Group
Serious events: 10 serious events
Other events: 742 other events
Deaths: 0 deaths
Fluzone Group
Serious events: 6 serious events
Other events: 710 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Flulaval Group
n=1055 participants at risk
subjects received Flulaval™ vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
|
Fluzone Group
n=1061 participants at risk
subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.19%
2/1055 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
0.09%
1/1061 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
Infections and infestations
Herpangina
|
0.09%
1/1055 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
0.09%
1/1061 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
Infections and infestations
Oral candidiasis
|
0.09%
1/1055 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
0.09%
1/1061 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
Infections and infestations
Abscess
|
0.09%
1/1055 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
0.00%
0/1061 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
Psychiatric disorders
Affective disorder
|
0.09%
1/1055 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
0.00%
0/1061 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
Infections and infestations
Appendicitis
|
0.09%
1/1055 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
0.00%
0/1061 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/1055 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
0.09%
1/1061 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.09%
1/1055 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
0.00%
0/1061 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/1055 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
0.09%
1/1061 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
Infections and infestations
Cellulitis
|
0.09%
1/1055 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
0.00%
0/1061 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
Nervous system disorders
Convulsion
|
0.09%
1/1055 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
0.00%
0/1061 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.09%
1/1055 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
0.00%
0/1061 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1055 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
0.09%
1/1061 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
Infections and infestations
H1N1 influenza
|
0.09%
1/1055 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
0.00%
0/1061 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1055 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
0.09%
1/1061 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
Psychiatric disorders
Oppositional defiant disorder
|
0.09%
1/1055 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
0.00%
0/1061 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.09%
1/1055 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
0.00%
0/1061 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sinus polyp
|
0.00%
0/1055 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
0.09%
1/1061 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
Immune system disorders
Type 1 diabetes mellitus
|
0.00%
0/1055 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
0.09%
1/1061 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
0.09%
1/1055 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
0.00%
0/1061 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
Other adverse events
| Measure |
Flulaval Group
n=1055 participants at risk
subjects received Flulaval™ vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
|
Fluzone Group
n=1061 participants at risk
subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:
* 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
* 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.2%
129/1055 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
10.8%
115/1061 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
General disorders
Pyrexia
|
5.9%
62/1055 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
5.7%
60/1061 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
General disorders
Arthralgia
|
9.3%
70/750 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
10.7%
80/747 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
General disorders
Fatigue
|
18.4%
138/750 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
18.3%
137/747 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
General disorders
Headache
|
18.8%
141/750 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
17.5%
131/747 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
General disorders
Muscle aches
|
26.7%
200/750 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
25.3%
189/747 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
General disorders
Shivering
|
6.0%
45/750 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
5.4%
40/747 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
General disorders
Drowsiness
|
20.8%
61/293 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
22.6%
63/279 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
General disorders
Irritability
|
29.4%
86/293 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
31.2%
87/279 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
General disorders
Loss of appetite
|
17.7%
52/293 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
16.8%
47/279 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
General disorders
Temperature
|
5.1%
15/293 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
3.6%
10/279 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
General disorders
Pain
|
59.0%
615/1043 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
56.9%
584/1026 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
General disorders
Redness
|
5.5%
57/1043 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
5.2%
53/1026 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
|
General disorders
Swelling
|
4.9%
51/1043 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
5.8%
59/1026 • Solicited AEs: During a 4-day follow-up period (Days 0-3) after vaccination; Unsolicited AEs:During a 28 day follow-up period (Days 0-27) after vaccination.; SAEs: During the entire study period (From Day 0 up to Day 180).
Safety data were collected and tabulated for all subjects regardless of age categories but solicited general symptoms were collected and tabulated for subjects below 5 years of age and for subjects of 5 years of age and above. Solicited symtoms were assessed for subjects who daily recorded AEs and who returned the diary card post-vaccination.
|
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