Trial Outcomes & Findings for Immunogenicity and Safety Study of Fluarix™ Vaccine in Children Who Have Previously Been Vaccinated With Pandemrix™ (NCT NCT01196026)
NCT ID: NCT01196026
Last Updated: 2018-09-24
Results Overview
Antibody titers were expressed as Geometric mean titers (GMTs).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
162 participants
Primary outcome timeframe
Day 0 and 28
Results posted on
2018-09-24
Participant Flow
Primed subjects =subjects who had been previously vaccinated with a seasonal influenza vaccine whereas unprimed subjects had not. * children ≥ 9 years + primed children \< 9 years=1 dose of Fluarix * unprimed children \< 9 years=2 doses of Fluarix. To complete the vaccination schedule, a 2nd dose of Havrix vaccine was given outside the study setting
162 subjects were enrolled in the study but only 154 subjects were vaccinated. The remaining 8 subjects gave their consent withdrawal and were not included in the study.Enrollment was stratified according to the age at first Pandemrix vaccination: 6-11 months, 12-35 months, 3-9 years. Also, subjects were grouped from 3-5 and from 6-9 years.
Participant milestones
| Measure |
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
44
|
23
|
10
|
43
|
24
|
|
Overall Study
Completed at Day 28
|
9
|
41
|
23
|
10
|
42
|
24
|
|
Overall Study
COMPLETED
|
9
|
36
|
23
|
10
|
42
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
8
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
0
|
0
|
1
|
0
|
|
Overall Study
Other
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Immunogenicity and Safety Study of Fluarix™ Vaccine in Children Who Have Previously Been Vaccinated With Pandemrix™
Baseline characteristics by cohort
| Measure |
Fluarix 6-11 Months Group
n=10 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=44 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=23 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
n=10 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
n=43 Participants
Subjects aged 12-35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine.
|
Havrix Junior 3-9 Years Group
n=24 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
1.0 Years
STANDARD_DEVIATION 0.00 • n=99 Participants
|
2.3 Years
STANDARD_DEVIATION 0.52 • n=107 Participants
|
6.4 Years
STANDARD_DEVIATION 1.99 • n=206 Participants
|
1.0 Years
STANDARD_DEVIATION 0.00 • n=7 Participants
|
2.4 Years
STANDARD_DEVIATION 0.58 • n=31 Participants
|
7.5 Years
STANDARD_DEVIATION 1.53 • n=30 Participants
|
3.58 Years
STANDARD_DEVIATION 2.54 • n=3 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
13 Participants
n=30 Participants
|
72 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
11 Participants
n=30 Participants
|
82 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Day 0 and 28Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.
Antibody titers were expressed as Geometric mean titers (GMTs).
Outcome measures
| Measure |
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
n=65 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine
Day 0
|
—
|
—
|
—
|
—
|
—
|
—
|
120.7 titer
Interval 100.8 to 144.4
|
—
|
|
Haemagglutination Inhibition (HI) Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine
Day 28
|
—
|
—
|
—
|
—
|
—
|
—
|
1079.3 titer
Interval 915.8 to 1272.0
|
—
|
PRIMARY outcome
Timeframe: Day 0-28Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.
Seropositivity was defined as antibody titers greater than or equal to 1:10.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
n=65 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Seropositive for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
Day 28
|
—
|
—
|
—
|
—
|
—
|
—
|
65 Participants
|
—
|
|
Number of Subjects Seropositive for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
Day 0
|
—
|
—
|
—
|
—
|
—
|
—
|
65 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 0-28Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
n=65 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Seroprotected for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
Day 0
|
—
|
—
|
—
|
—
|
—
|
—
|
63 Participants
|
—
|
|
Number of Subjects Seroprotected for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
Day 28
|
—
|
—
|
—
|
—
|
—
|
—
|
65 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 28Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.
A seroconverted subject was defined as a subject that had either a prevaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
n=65 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Seroconverted for HI Antibodies Against H1N1 in All Subjects Receiving Fluarix Vaccine
|
—
|
—
|
—
|
—
|
—
|
—
|
55 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 28Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. The data presented here are only for the Fluarix All Ages Group. Similar data for other groups will be presented as Secondary Outcome Measure.
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
n=65 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in All Subjects Receiving Fluarix Vaccine
|
—
|
—
|
—
|
—
|
—
|
—
|
8.9 ratio
Interval 7.1 to 11.2
|
—
|
SECONDARY outcome
Timeframe: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available.
Antibody titers were expressed as GMTs. Vaccine strains included in the analysis were Flu A/CAL/7/09 H1N1 , FluB/Bri/60/08 Victoria, and Flu A/Vic/210/09 H3N2, further in this summary denoted as H1N1, Victoria and H3N2 strains, respectively.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=7 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=35 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=23 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
n=10 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
n=43 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
n=24 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
n=65 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
n=77 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
HI Antibody Titers Against All Fluarix Vaccine Strains
H1N1 Day 0
|
176.6 titer
Interval 79.3 to 393.4
|
124.9 titer
Interval 97.1 to 160.5
|
102.0 titer
Interval 77.2 to 134.9
|
171.4 titer
Interval 118.9 to 247.2
|
186.5 titer
Interval 148.8 to 233.8
|
105.3 titer
Interval 75.4 to 147.0
|
120.7 titer
Interval 100.8 to 144.4
|
154.4 titer
Interval 129.8 to 183.7
|
|
HI Antibody Titers Against All Fluarix Vaccine Strains
H1N1 Day 28
|
1810.2 titer
Interval 775.2 to 4226.8
|
1345.0 titer
Interval 1141.9 to 1584.1
|
659.7 titer
Interval 524.1 to 830.3
|
NA titer
Data not planned to be collected at Day 28, but rather at Month 6.
|
NA titer
Data not planned to be collected at Day 28, but rather at Month 6.
|
NA titer
Data not planned to be collected at Day 28, but rather at Month 6.
|
1079.3 titer
Interval 915.8 to 1272.0
|
NA titer
Data not planned to be collected at Day 28, but rather at Month 6.
|
|
HI Antibody Titers Against All Fluarix Vaccine Strains
Victoria Day 0
|
16.4 titer
Interval 3.7 to 71.9
|
15.1 titer
Interval 10.6 to 21.5
|
21.9 titer
Interval 14.0 to 34.1
|
13.6 titer
Interval 7.6 to 24.6
|
19.1 titer
Interval 14.4 to 25.4
|
19.1 titer
Interval 12.3 to 29.6
|
17.4 titer
Interval 13.2 to 22.8
|
18.3 titer
Interval 14.8 to 22.7
|
|
HI Antibody Titers Against All Fluarix Vaccine Strains
H3N2 Day 28
|
88.4 titer
Interval 35.9 to 217.6
|
448.3 titer
Interval 265.9 to 755.8
|
518.6 titer
Interval 304.1 to 884.3
|
NA titer
Data not planned to be collected at Day 28, but rather at Month 6.
|
NA titer
Data not planned to be collected at Day 28, but rather at Month 6.
|
NA titer
Data not planned to be collected at Day 28, but rather at Month 6.
|
396.3 titer
Interval 276.3 to 568.5
|
NA titer
Data not planned to be collected at Day 28, but rather at Month 6.
|
|
HI Antibody Titers Against All Fluarix Vaccine Strains
Victoria Day 28
|
176.8 titer
Interval 28.1 to 1111.2
|
142.2 titer
Interval 93.5 to 216.2
|
188.8 titer
Interval 103.7 to 343.8
|
NA titer
Data not planned to be collected at Day 28, but rather at Month 6.
|
NA titer
Data not planned to be collected at Day 28, but rather at Month 6.
|
NA titer
Data not planned to be collected at Day 28, but rather at Month 6.
|
160.9 titer
Interval 115.0 to 225.2
|
NA titer
Data not planned to be collected at Day 28, but rather at Month 6.
|
|
HI Antibody Titers Against All Fluarix Vaccine Strains
H3N2 Day 0
|
5.0 titer
Interval 5.0 to 5.0
|
21.2 titer
Interval 13.7 to 32.8
|
31.0 titer
Interval 19.0 to 50.5
|
5.0 titer
Interval 5.0 to 5.0
|
8.9 titer
Interval 6.4 to 12.4
|
26.7 titer
Interval 16.6 to 42.9
|
20.8 titer
Interval 15.2 to 28.3
|
11.7 titer
Interval 8.9 to 15.2
|
SECONDARY outcome
Timeframe: Day 0 and Month 6Population: Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
Antibody titers were expressed as GMTs. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=6 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=28 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=22 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
n=9 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
n=38 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
n=23 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
n=56 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
n=70 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Victoria Day 0
|
17.8 titer
Interval 2.9 to 110.0
|
16.2 titer
Interval 10.6 to 24.6
|
21.6 titer
Interval 13.6 to 34.5
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
18.3 titer
Interval 13.5 to 24.8
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
|
HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H3N2 Day 0
|
5.0 titer
Interval 5.0 to 5.0
|
20.3 titer
Interval 12.4 to 33.0
|
29.7 titer
Interval 17.9 to 49.2
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
20.3 titer
Interval 14.5 to 28.2
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
|
HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H3N2 Month 6
|
127.0 titer
Interval 70.1 to 230.0
|
160.0 titer
Interval 119.1 to 214.8
|
252.7 titer
Interval 186.3 to 342.8
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
186.8 titer
Interval 152.9 to 228.2
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
|
HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H1N1 Day 0
|
201.6 titer
Interval 81.1 to 501.1
|
126.4 titer
Interval 93.2 to 171.4
|
96.9 titer
Interval 73.9 to 126.9
|
172.8 titer
Interval 113.9 to 262.1
|
195.6 titer
Interval 155.1 to 246.6
|
100.3 titer
Interval 71.8 to 140.1
|
119.7 titer
Interval 97.9 to 146.3
|
154.6 titer
Interval 128.8 to 185.5
|
|
HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H1N1 Month 6
|
1437.0 titer
Interval 595.7 to 3466.6
|
565.5 titer
Interval 458.1 to 698.2
|
335.5 titer
Interval 253.1 to 444.7
|
93.4 titer
Interval 48.6 to 179.5
|
172.0 titer
Interval 127.9 to 231.4
|
74.3 titer
Interval 55.4 to 99.6
|
509.0 titer
Interval 416.9 to 621.5
|
120.7 titer
Interval 97.2 to 149.8
|
|
HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Victoria Month 6
|
302.0 titer
Interval 115.6 to 788.8
|
148.4 titer
Interval 97.9 to 225.1
|
134.5 titer
Interval 82.2 to 220.1
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
154.1 titer
Interval 115.3 to 205.9
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
SECONDARY outcome
Timeframe: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available.
Seropositivity was defined as antibody titers greater than or equal to 1:10. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=7 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=35 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=23 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
n=10 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
n=43 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
n=24 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
n=65 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
n=77 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains
H1N1 Day 0
|
7 Participants
|
35 Participants
|
23 Participants
|
10 Participants
|
43 Participants
|
24 Participants
|
65 Participants
|
77 Participants
|
|
Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains
H1N1 Day 28
|
7 Participants
|
35 Participants
|
23 Participants
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
65 Participants
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
|
Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains
Victoria Day 0
|
4 Participants
|
25 Participants
|
20 Participants
|
9 Participants
|
39 Participants
|
20 Participants
|
49 Participants
|
68 Participants
|
|
Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains
Victoria Day 28
|
7 Participants
|
35 Participants
|
23 Participants
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
65 Participants
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
|
Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains
H3N2 Day 0
|
0 Participants
|
22 Participants
|
19 Participants
|
0 Participants
|
11 Participants
|
19 Participants
|
41 Participants
|
30 Participants
|
|
Number of Subjects Seropositive for HI Antibodies Against All Fluarix Vaccine Strains
H3N2 Day 28
|
7 Participants
|
35 Participants
|
23 Participants
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
65 Participants
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
SECONDARY outcome
Timeframe: Day 0 and Month 6Population: Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
Seropositivity was defined as antibody titers greater than or equal to 1:10. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=6 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=28 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=22 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
n=9 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
n=38 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
n=23 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
n=56 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
n=70 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H1N1 Day 0
|
6 Participants
|
28 Participants
|
22 Participants
|
9 Participants
|
38 Participants
|
23 Participants
|
56 Participants
|
70 Participants
|
|
Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Victoria Day 0
|
3 Participants
|
21 Participants
|
19 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
43 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
|
Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Victoria Month 6
|
6 Participants
|
28 Participants
|
22 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
56 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
|
Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H3N2 Day 0
|
0 Participants
|
17 Participants
|
18 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
35 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
|
Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H3N2 Month 6
|
6 Participants
|
28 Participants
|
22 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
56 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
|
Number of Subjects Seropositive for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H1N1 Month 6
|
6 Participants
|
28 Participants
|
22 Participants
|
9 Participants
|
38 Participants
|
23 Participants
|
56 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.
A seroconverted subject was defined as a subject that had either a pre-vaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=7 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=35 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=23 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
n=65 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine
Victoria
|
7 Participants
|
30 Participants
|
18 Participants
|
—
|
—
|
—
|
55 Participants
|
—
|
|
Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine
H3N2
|
7 Participants
|
35 Participants
|
22 Participants
|
—
|
—
|
—
|
64 Participants
|
—
|
|
Number of Subjects Seroconverted for HI Antibodies Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine
H1N1
|
5 Participants
|
31 Participants
|
19 Participants
|
—
|
—
|
—
|
55 Participants
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
A seroconverted subject was defined as a subject that had either a pre-vaccination (Day 0) titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=6 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=28 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=22 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
n=9 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
n=38 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
n=23 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
n=56 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
n=70 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H1N1
|
5 Participants
|
18 Participants
|
12 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
35 Participants
|
1 Participants
|
|
Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Victoria
|
5 Participants
|
22 Participants
|
15 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
42 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
|
Number of Subjects Seroconverted for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H3N2
|
6 Participants
|
22 Participants
|
18 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
46 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
SECONDARY outcome
Timeframe: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available.
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=7 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=35 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=23 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
n=10 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
n=43 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
n=24 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
n=65 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
n=77 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains
H1N1 Day 0
|
7 Participants
|
33 Participants
|
23 Participants
|
10 Participants
|
43 Participants
|
24 Participants
|
63 Participants
|
77 Participants
|
|
Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains
H1N1 Day 28
|
7 Participants
|
35 Participants
|
23 Participants
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
65 Participants
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
|
Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains
H3N2 Day 28
|
7 Participants
|
35 Participants
|
23 Participants
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
65 Participants
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
|
Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains
Victoria Day 0
|
2 Participants
|
5 Participants
|
7 Participants
|
1 Participants
|
9 Participants
|
7 Participants
|
14 Participants
|
17 Participants
|
|
Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains
Victoria Day 28
|
7 Participants
|
35 Participants
|
21 Participants
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
63 Participants
|
NA Participants
Data not planned to be collected at Day 28, but rather at Month 6.
|
|
Number of Subjects Seroprotected for HI Antibodies Against All Fluarix Vaccine Strains
H3N2 Day 0
|
0 Participants
|
17 Participants
|
13 Participants
|
0 Participants
|
6 Participants
|
12 Participants
|
30 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Day 0 and Month 6Population: Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=6 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=28 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=22 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
n=9 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
n=38 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
n=23 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
n=56 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
n=70 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H1N1 Day 0
|
6 Participants
|
26 Participants
|
22 Participants
|
9 Participants
|
38 Participants
|
23 Participants
|
54 Participants
|
70 Participants
|
|
Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H1N1 Month 6
|
6 Participants
|
28 Participants
|
22 Participants
|
8 Participants
|
36 Participants
|
21 Participants
|
56 Participants
|
65 Participants
|
|
Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Victoria Day 0
|
2 Participants
|
5 Participants
|
7 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
14 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
|
Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Victoria Month 6
|
6 Participants
|
26 Participants
|
20 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
52 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
|
Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H3N2 Day 0
|
0 Participants
|
13 Participants
|
12 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
25 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
|
Number of Subjects Seroprotected for HI Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H3N2 Month 6
|
6 Participants
|
28 Participants
|
22 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
56 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
SECONDARY outcome
Timeframe: Day 28Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 28) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=7 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=35 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=23 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
n=65 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine
H1N1
|
10.2 ratio
Interval 3.0 to 34.8
|
10.8 ratio
Interval 7.9 to 14.7
|
6.5 ratio
Interval 4.7 to 8.8
|
—
|
—
|
—
|
8.9 ratio
Interval 7.1 to 11.2
|
—
|
|
Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine
H3N2
|
17.7 ratio
Interval 7.2 to 43.5
|
21.1 ratio
Interval 16.3 to 27.4
|
16.7 ratio
Interval 11.4 to 24.6
|
—
|
—
|
—
|
19.1 ratio
Interval 15.6 to 23.4
|
—
|
|
Mean Geometric Increase (MGI) in HI Antibody Titers Against All Fluarix Vaccine Strains in All Subjects Receiving Fluarix Vaccine
Victoria
|
10.8 ratio
Interval 5.9 to 19.6
|
9.4 ratio
Interval 6.8 to 12.9
|
8.6 ratio
Interval 5.5 to 13.6
|
—
|
—
|
—
|
9.3 ratio
Interval 7.3 to 11.7
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination (Month 6) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=6 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=28 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=22 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
n=9 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
n=38 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
n=23 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
n=56 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
n=70 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H1N1
|
7.1 ratio
Interval 2.0 to 25.5
|
4.5 ratio
Interval 3.3 to 6.0
|
3.5 ratio
Interval 2.6 to 4.7
|
0.5 ratio
Interval 0.4 to 0.8
|
0.9 ratio
Interval 0.7 to 1.1
|
0.7 ratio
Interval 0.7 to 0.8
|
4.3 ratio
Interval 3.4 to 5.3
|
0.8 ratio
Interval 0.7 to 0.9
|
|
Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Victoria
|
17.0 ratio
Interval 3.1 to 93.9
|
9.2 ratio
Interval 5.9 to 14.2
|
6.2 ratio
Interval 3.8 to 10.2
|
NA ratio
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA ratio
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA ratio
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
8.4 ratio
Interval 6.1 to 11.6
|
NA ratio
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
|
Mean Geometric Increase (MGI) in HI Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H3N2
|
25.4 ratio
Interval 14.0 to 46.0
|
7.9 ratio
Interval 5.5 to 11.4
|
8.5 ratio
Interval 5.9 to 12.3
|
NA ratio
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA ratio
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA ratio
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
9.2 ratio
Interval 7.2 to 11.8
|
NA ratio
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
SECONDARY outcome
Timeframe: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.
Antibody titers were expressed as Geometric Mean Titers (GMTs).
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=7 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=35 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=23 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
n=65 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains
H1N1 Day 0
|
359.1 titer
Interval 159.7 to 807.4
|
235.4 titer
Interval 180.5 to 307.0
|
237.6 titer
Interval 154.7 to 364.8
|
—
|
—
|
—
|
247.3 titer
Interval 199.6 to 306.5
|
—
|
|
Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains
H1N1 Day 28
|
5706.2 titer
Interval 3382.6 to 9626.0
|
5860.4 titer
Interval 5072.5 to 6770.7
|
2052.3 titer
Interval 1395.1 to 3019.0
|
—
|
—
|
—
|
4007.7 titer
Interval 3274.8 to 4904.6
|
—
|
|
Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains
Victoria Day 0
|
20.2 titer
Interval 8.3 to 49.2
|
19.1 titer
Interval 13.9 to 26.2
|
25.4 titer
Interval 16.6 to 38.9
|
—
|
—
|
—
|
21.3 titer
Interval 16.8 to 26.9
|
—
|
|
Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains
Victoria Day 28
|
49.3 titer
Interval 6.9 to 349.5
|
42.3 titer
Interval 20.9 to 85.5
|
80.8 titer
Interval 34.8 to 187.9
|
—
|
—
|
—
|
54.3 titer
Interval 33.0 to 89.3
|
—
|
|
Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains
H3N2 Day 0
|
30.0 titer
Interval 13.5 to 66.9
|
84.9 titer
Interval 53.7 to 134.5
|
139.5 titer
Interval 100.8 to 193.0
|
—
|
—
|
—
|
90.5 titer
Interval 67.4 to 121.6
|
—
|
|
Serum Neutralising Antibody Titers Against All Fluarix Vaccine Strains
H3N2 Day 28
|
90.1 titer
Interval 50.1 to 162.0
|
1011.6 titer
Interval 509.5 to 2008.6
|
1229.9 titer
Interval 586.5 to 2579.3
|
—
|
—
|
—
|
832.9 titer
Interval 514.7 to 1347.8
|
—
|
SECONDARY outcome
Timeframe: Day 0 and Month 6Population: Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
Antibody titers were expressed as GMTs.\] Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=6 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=28 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=22 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
n=9 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
n=38 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
n=23 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
n=56 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
n=70 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Victoria Day 0
|
21.4 titer
Interval 7.2 to 64.0
|
20.7 titer
Interval 13.9 to 30.7
|
26.1 titer
Interval 16.8 to 40.6
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
22.7 titer
Interval 17.4 to 29.7
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
|
Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H3N2 Month 6
|
264.1 titer
Interval 136.0 to 512.9
|
618.2 titer
Interval 435.1 to 878.5
|
638.2 titer
Interval 381.1 to 1068.8
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
571.5 titer
Interval 435.5 to 749.8
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
|
Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H1N1 Day 0
|
419.1 titer
Interval 172.0 to 1021.2
|
254.8 titer
Interval 184.0 to 352.8
|
221.2 titer
Interval 145.0 to 337.6
|
292.0 titer
Interval 170.8 to 499.1
|
441.3 titer
Interval 317.5 to 613.5
|
212.8 titer
Interval 142.3 to 318.1
|
254.2 titer
Interval 200.2 to 322.9
|
329.3 titer
Interval 260.0 to 417.2
|
|
Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H1N1 Month 6
|
5080.1 titer
Interval 2169.7 to 11894.4
|
2359.7 titer
Interval 1852.0 to 3006.4
|
892.2 titer
Interval 585.7 to 1359.0
|
292.6 titer
Interval 173.6 to 493.0
|
528.9 titer
Interval 377.5 to 741.0
|
221.6 titer
Interval 155.0 to 316.8
|
1748.2 titer
Interval 1347.3 to 2268.4
|
368.3 titer
Interval 290.1 to 467.5
|
|
Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Victoria Month 6
|
284.5 titer
Interval 89.4 to 905.6
|
140.0 titer
Interval 81.7 to 240.0
|
113.1 titer
Interval 58.2 to 219.7
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
138.9 titer
Interval 95.2 to 202.6
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
|
Serum Neutralising Antibody Titers Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H3N2 Day 0
|
34.1 titer
Interval 13.6 to 85.3
|
78.4 titer
Interval 47.0 to 131.1
|
136.5 titer
Interval 97.4 to 191.3
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
89.2 titer
Interval 65.5 to 121.5
|
NA titer
Titers were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
SECONDARY outcome
Timeframe: Day 0 (for all groups) and Day 28 (for groups receiving Fluarix only)Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.
Seropositivity was defined as antibody titers greater than or equal to 1:28.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=7 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=35 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=23 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
n=65 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains
H1N1 Day 0
|
7 Participants
|
34 Participants
|
23 Participants
|
—
|
—
|
—
|
64 Participants
|
—
|
|
Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains
Victoria Day 28
|
3 Participants
|
15 Participants
|
12 Participants
|
—
|
—
|
—
|
30 Participants
|
—
|
|
Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains
H3N2 Day 0
|
4 Participants
|
26 Participants
|
22 Participants
|
—
|
—
|
—
|
52 Participants
|
—
|
|
Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains
H1N1 Day 28
|
7 Participants
|
34 Participants
|
23 Participants
|
—
|
—
|
—
|
64 Participants
|
—
|
|
Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains
Victoria Day 0
|
1 Participants
|
5 Participants
|
7 Participants
|
—
|
—
|
—
|
13 Participants
|
—
|
|
Number of Subjects Seropositive for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains
H3N2 Day28
|
7 Participants
|
34 Participants
|
23 Participants
|
—
|
—
|
—
|
64 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 0 and Month 6Population: Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
Seropositivity was defined as antibody titers greater than or equal to 1:28. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=6 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=28 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=22 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
n=9 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
n=38 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
n=23 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
n=56 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
n=70 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H3N2 Month 6
|
6 Participants
|
28 Participants
|
22 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
56 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
|
Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H1N1 Day 0
|
6 Participants
|
27 Participants
|
22 Participants
|
9 Participants
|
38 Participants
|
23 Participants
|
55 Participants
|
70 Participants
|
|
Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Victoria Day 0
|
1 Participants
|
5 Participants
|
7 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
13 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
|
Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Victoria Month 6
|
6 Participants
|
28 Participants
|
18 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
52 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
|
Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H3N2 Day 0
|
4 Participants
|
20 Participants
|
21 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
45 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
|
Number of Subjects Seropositive for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H1N1 Month 6
|
6 Participants
|
28 Participants
|
22 Participants
|
9 Participants
|
38 Participants
|
23 Participants
|
56 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity at Day 28 which included all evaluable subjects for whom immunogenicity data at day 28 were available. Analysis was done only on those groups receiving the Fluarix vaccine.
Seroconverted subject was a subject with a minimum 4-fold increase in titer at post-vaccination for neutralizing antibody response.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=7 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=34 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=23 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
n=64 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix
H1N1
|
6 Participants
|
33 Participants
|
17 Participants
|
—
|
—
|
—
|
56 Participants
|
—
|
|
Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix
Victoria
|
3 Participants
|
11 Participants
|
11 Participants
|
—
|
—
|
—
|
25 Participants
|
—
|
|
Number of Subjects Seroconverted for Serum Neutralising Antibodies Against All Fluarix Vaccine Strains in Subjects Receiving Fluarix
H3N2
|
4 Participants
|
32 Participants
|
16 Participants
|
—
|
—
|
—
|
52 Participants
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: Analysis was performed on According-to-Protocol (ATP) cohort for persistence at Month 6 which included all evaluable subjects for whom immunogenicity data at Month 6 were available.
Seroconverted subject was a subject with a minimum 4-fold increase in titer at post-vaccination for neutralizing antibody response. Vaccine strains included in the analysis were H1N1, Victoria and H3N2 strains for subjects in groups receiving Fluarix vaccine and H1N1 strain for subjects in groups receiving Havrix Junior Vaccine.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=6 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=28 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=22 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
n=9 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
n=38 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
n=23 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
n=56 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
n=70 Participants
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H1N1
|
5 Participants
|
22 Participants
|
10 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
37 Participants
|
2 Participants
|
|
Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
Victoria
|
6 Participants
|
23 Participants
|
13 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
42 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
|
Number of Subjects Seroconverted for Serum Neutralising Antibodies Against H1N1 in Subjects Receiving Havrix Junior Vaccine
H3N2
|
5 Participants
|
21 Participants
|
13 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
39 Participants
|
NA Participants
Results were available only against H1N1 antigen in subjects receiving Havrix Junior Vaccine.
|
SECONDARY outcome
Timeframe: During the 7 days (Day 0 - 6) after vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, on subjects that had completed their symptom sheet for the respective vaccine dose only.
Solicited local symptoms assessed include: pain, redness and swelling. Any is any symptom regardless of intensity. Grade 3 was defined as a symptom that prevented normal activity.above 50 millimeter.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=10 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=43 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=23 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
n=10 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
n=43 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
n=24 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Pain
|
3 Participants
|
28 Participants
|
21 Participants
|
5 Participants
|
19 Participants
|
14 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Redness
|
7 Participants
|
33 Participants
|
19 Participants
|
2 Participants
|
15 Participants
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness
|
2 Participants
|
8 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Swelling
|
5 Participants
|
23 Participants
|
11 Participants
|
1 Participants
|
10 Participants
|
5 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7 days (Days 0 - 6) after vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, on subjects that had completed their symptom sheet and reported the respective symptom only.
Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include: pain, redness and swelling.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=6 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=30 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=20 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
n=5 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
n=19 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
n=14 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Any Solicited Local Symptom
Pain [Dose 1]
|
1.0 days
Interval 1.0 to 2.0
|
2.0 days
Interval 1.0 to 5.0
|
2.0 days
Interval 1.0 to 5.0
|
1.0 days
Interval 1.0 to 5.0
|
1.0 days
Interval 1.0 to 7.0
|
2.0 days
Interval 1.0 to 4.0
|
—
|
—
|
|
Duration of Any Solicited Local Symptom
Redness [Dose 1]
|
4.0 days
Interval 1.0 to 6.0
|
3.0 days
Interval 1.0 to 7.0
|
3.0 days
Interval 1.0 to 6.0
|
1.5 days
Interval 1.0 to 2.0
|
3.0 days
Interval 1.0 to 7.0
|
2.0 days
Interval 1.0 to 5.0
|
—
|
—
|
|
Duration of Any Solicited Local Symptom
Swelling [Dose 1]
|
2.0 days
Interval 1.0 to 5.0
|
3.0 days
Interval 1.0 to 6.0
|
2.0 days
Interval 1.0 to 6.0
|
1.0 days
Interval 1.0 to 1.0
|
2.0 days
Interval 1.0 to 7.0
|
2.0 days
Interval 1.0 to 3.0
|
—
|
—
|
|
Duration of Any Solicited Local Symptom
Pain [Dose 2]
|
1.5 days
Interval 1.0 to 2.0
|
1.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 3.0
|
NA days
None of the subjects from the Havrix Groups received a second vaccine dose within the frame of this study.
|
NA days
None of the subjects from the Havrix Groups received a second vaccine dose within the frame of this study.
|
NA days
None of the subjects from the Havrix Groups received a second vaccine dose within the frame of this study.
|
—
|
—
|
|
Duration of Any Solicited Local Symptom
Redness [Dose 2]
|
3.0 days
Interval 3.0 to 7.0
|
3.0 days
Interval 1.0 to 6.0
|
2.0 days
Interval 1.0 to 5.0
|
NA days
None of the subjects from the Havrix Groups received a second vaccine dose within the frame of this study.
|
NA days
None of the subjects from the Havrix Groups received a second vaccine dose within the frame of this study.
|
NA days
None of the subjects from the Havrix Groups received a second vaccine dose within the frame of this study.
|
—
|
—
|
|
Duration of Any Solicited Local Symptom
Swelling [Dose 2]
|
3.0 days
Interval 2.0 to 4.0
|
2.0 days
Interval 1.0 to 6.0
|
2.0 days
Interval 1.0 to 4.0
|
NA days
None of the subjects from the Havrix Groups received a second vaccine dose within the frame of this study.
|
NA days
None of the subjects from the Havrix Groups received a second vaccine dose within the frame of this study.
|
NA days
None of the subjects from the Havrix Groups received a second vaccine dose within the frame of this study.
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7 days (Days 0-6) after vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, on subjects aged less than 6 years that had completed their symptom sheet for the respective vaccine dose only.
Solicited general symptoms assessed include diarrhoea, drowsiness, irritability, loss of appetite and fever. Any was defined as any symptom regardless of intensity; any fever was axillary temperature greater than or equal to 37.5 degrees celsius. Grade 3 was a symptom preventing normal everyday activity; grade 3 loss of appetite was not eating at all; grade 3 fever was axillary temperature above 39 degrees celsius. Related was any symptom assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=10 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=43 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=11 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
n=10 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
n=43 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
n=2 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Loss of Appetite
|
4 Participants
|
8 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Diarrhoea
|
5 Participants
|
8 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Diarrhoea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Diarrhoea
|
5 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness
|
6 Participants
|
16 Participants
|
2 Participants
|
2 Participants
|
15 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness
|
5 Participants
|
10 Participants
|
2 Participants
|
2 Participants
|
9 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Irritability
|
6 Participants
|
20 Participants
|
4 Participants
|
5 Participants
|
14 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Irritability
|
5 Participants
|
14 Participants
|
3 Participants
|
4 Participants
|
10 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Loss of Appetite
|
6 Participants
|
14 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of Appetite
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Fever
|
5 Participants
|
14 Participants
|
4 Participants
|
3 Participants
|
11 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Fever
|
4 Participants
|
11 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: During a 7-day follow-up period (Day 0-6) after vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, on subjects aged less than 6 years that had completed their symptom sheet for the respective vaccine dose only.
Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include diarrhoea, drowsiness, irritability, loss of appetite and fever.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=5 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=14 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=3 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
n=5 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
n=15 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old
Diarrhoea [Dose 1]
|
2.0 days
Interval 2.0 to 3.0
|
2.0 days
Interval 1.0 to 4.0
|
1.0 days
Interval 1.0 to 1.0
|
3.5 days
Interval 1.0 to 6.0
|
1.0 days
Interval 1.0 to 3.0
|
—
|
—
|
—
|
|
Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old
Drowsiness [Dose 1]
|
1.5 days
Interval 1.0 to 6.0
|
1.0 days
Interval 1.0 to 4.0
|
3.0 days
Interval 3.0 to 3.0
|
2.0 days
Interval 2.0 to 2.0
|
2.0 days
Interval 1.0 to 6.0
|
—
|
—
|
—
|
|
Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old
Irritability [Dose 1]
|
2.5 days
Interval 1.0 to 4.0
|
2.0 days
Interval 1.0 to 5.0
|
1.0 days
Interval 1.0 to 2.0
|
2.0 days
Interval 1.0 to 6.0
|
1.0 days
Interval 1.0 to 5.0
|
—
|
—
|
—
|
|
Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old
Loss of Appetite [Dose 1]
|
2.0 days
Interval 1.0 to 6.0
|
3.0 days
Interval 1.0 to 5.0
|
1.0 days
Interval 1.0 to 3.0
|
2.0 days
Interval 1.0 to 7.0
|
1.5 days
Interval 1.0 to 3.0
|
—
|
—
|
—
|
|
Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old
Fever [Dose 1]
|
4.0 days
Interval 1.0 to 6.0
|
1.5 days
Interval 1.0 to 3.0
|
1.5 days
Interval 1.0 to 2.0
|
2.0 days
Interval 2.0 to 2.0
|
2.0 days
Interval 1.0 to 6.0
|
—
|
—
|
—
|
|
Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old
Diarrhoea [Dose 2]
|
1.0 days
Interval 1.0 to 3.0
|
1.0 days
Interval 1.0 to 4.0
|
1.0 days
Interval 1.0 to 1.0
|
NA days
None of the subjects in any of the Havrix Groups received a second vaccine dose.
|
NA days
None of the subjects in any of the Havrix Groups received a second vaccine dose.
|
—
|
—
|
—
|
|
Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old
Drowsiness [Dose 2]
|
1.5 days
Interval 1.0 to 3.0
|
1.0 days
Interval 1.0 to 2.0
|
1.0 days
Interval 1.0 to 1.0
|
NA days
None of the subjects in any of the Havrix Groups received a second vaccine dose.
|
NA days
None of the subjects in any of the Havrix Groups received a second vaccine dose.
|
—
|
—
|
—
|
|
Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old
Irritability [Dose 2]
|
2.0 days
Interval 2.0 to 7.0
|
2.0 days
Interval 1.0 to 4.0
|
2.0 days
Interval 1.0 to 3.0
|
NA days
None of the subjects in any of the Havrix Groups received a second vaccine dose.
|
NA days
None of the subjects in any of the Havrix Groups received a second vaccine dose.
|
—
|
—
|
—
|
|
Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old
Loss of Appetite [Dose 2]
|
2.0 days
Interval 1.0 to 5.0
|
2.0 days
Interval 1.0 to 4.0
|
1.0 days
Interval 1.0 to 1.0
|
NA days
None of the subjects in any of the Havrix Groups received a second vaccine dose.
|
NA days
None of the subjects in any of the Havrix Groups received a second vaccine dose.
|
—
|
—
|
—
|
|
Duration of Any Solicited General Symptom Experienced by Subjects Less Than 6 Years Old
Fever [Dose 2]
|
2.0 days
Interval 1.0 to 2.0
|
1.0 days
Interval 1.0 to 7.0
|
1.0 days
Interval 1.0 to 1.0
|
NA days
None of the subjects in any of the Havrix Groups received a second vaccine dose.
|
NA days
None of the subjects in any of the Havrix Groups received a second vaccine dose.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During a 7-day follow-up period (Day 0-6) after vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, on subjects aged above 6 years that had completed their symptom sheet for the respective vaccine dose only.
Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and fever. Any was defined as any symptom regardless of intensity; any fever was axillary temperature greater than or equal to 37.5 degrees celsius. Grade 3 was a symptom preventing normal everyday activity; grade 3 fever was axillary temperature above 39 degrees celsius. Related was any symptom assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=12 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
n=22 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue
|
—
|
—
|
5 Participants
|
—
|
—
|
8 Participants
|
—
|
—
|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue
|
—
|
—
|
4 Participants
|
—
|
—
|
6 Participants
|
—
|
—
|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Any Gatrointestinal Symptoms
|
—
|
—
|
1 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gatrointestinal Symptoms
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Related Gatrointestinal Symptoms
|
—
|
—
|
1 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Any Headache
|
—
|
—
|
4 Participants
|
—
|
—
|
4 Participants
|
—
|
—
|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Related Headache
|
—
|
—
|
3 Participants
|
—
|
—
|
3 Participants
|
—
|
—
|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia
|
—
|
—
|
1 Participants
|
—
|
—
|
2 Participants
|
—
|
—
|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia
|
—
|
—
|
1 Participants
|
—
|
—
|
2 Participants
|
—
|
—
|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Any Shivering
|
—
|
—
|
2 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Shivering
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Related Shivering
|
—
|
—
|
2 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Any Sweating
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Sweating
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Related Sweating
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Any Fever
|
—
|
—
|
3 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Subjects Above 6 Years Reported Any, Grade 3 and Related Solicited General Symptoms
Related Fever
|
—
|
—
|
2 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: During a 7-day follow-up period (Day 0-6) after vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, on subjects aged above 6 years that had completed their symptom sheet for the respective vaccine dose only.
Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=4 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
n=8 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old
Fatigue [Dose 1]
|
—
|
—
|
1.5 days
Interval 1.0 to 5.0
|
—
|
—
|
1.0 days
Interval 1.0 to 2.0
|
—
|
—
|
|
Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old
Fatigue [Dose 2]
|
—
|
—
|
4.0 days
Interval 1.0 to 7.0
|
—
|
—
|
NA days
Dose 2 involved subjects in Group receiving Fluarix vaccine.
|
—
|
—
|
|
Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old
Gastrointestinal Symptoms [Dose 1]
|
—
|
—
|
2.0 days
Interval 2.0 to 2.0
|
—
|
—
|
1.0 days
Interval 1.0 to 1.0
|
—
|
—
|
|
Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old
Gastrointestinal symptoms [Dose 2]
|
—
|
—
|
NA days
None of the subjects aged above 6 years in this group experienced this symptom
|
—
|
—
|
NA days
Dose 2 involved subjects in Group receiving Fluarix vaccine.
|
—
|
—
|
|
Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old
Headache [Dose 1]
|
—
|
—
|
3.0 days
Interval 2.0 to 4.0
|
—
|
—
|
3.0 days
Interval 1.0 to 7.0
|
—
|
—
|
|
Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old
Headache [Dose 2]
|
—
|
—
|
3.5 days
Interval 3.0 to 4.0
|
—
|
—
|
NA days
Dose 2 involved subjects in Group receiving Fluarix vaccine.
|
—
|
—
|
|
Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old
Myalgia [Dose 1]
|
—
|
—
|
NA days
None of the subjects aged above 6 years in this group experienced this symptom.
|
—
|
—
|
1.0 days
Interval 1.0 to 1.0
|
—
|
—
|
|
Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old
Myalgia [Dose 2]
|
—
|
—
|
1.0 days
Interval 1.0 to 1.0
|
—
|
—
|
NA days
Dose 2 involved subjects in Group receiving Fluarix vaccine.
|
—
|
—
|
|
Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old
Shivering [Dose 1]
|
—
|
—
|
1.0 days
Interval 1.0 to 1.0
|
—
|
—
|
NA days
None of the subjects aged above 6 years in this group experienced this symptom.
|
—
|
—
|
|
Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old
Shivering [Dose 2]
|
—
|
—
|
NA days
None of the subjects aged above 6 years in this group experienced this symptom
|
—
|
—
|
NA days
Dose 2 involved subjects in Group receiving Fluarix vaccine.
|
—
|
—
|
|
Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old
Fever [Dose 1]
|
—
|
—
|
1.0 days
Interval 1.0 to 1.0
|
—
|
—
|
NA days
None of the subjects aged above 6 years in this group experienced this symptom.
|
—
|
—
|
|
Duration of Any Solicited General Symptom Experienced by Subjects Above 6 Years Old
Fever [Dose2]
|
—
|
—
|
1.0 days
Interval 1.0 to 1.0
|
—
|
—
|
NA days
Dose 2 involved subjects in Group receiving Fluarix vaccine.
|
—
|
—
|
SECONDARY outcome
Timeframe: During a 28 day follow-up period (Day 0-27) after vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as any symptom regardless of intensity or relationship to vaccination. Grade 3 was a symptom preventing normal everyday activity. Related was any symptom assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=10 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=44 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=23 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
n=10 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
n=43 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
n=24 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any AEs
|
6 Participants
|
20 Participants
|
7 Participants
|
3 Participants
|
15 Participants
|
7 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 AEs
|
3 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related AEs
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (up to Month 6)Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.
MAEs: subject received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. AESIs/pIMD: includes both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Adverse events of special interest include both convulsion and anaphylaxis.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=10 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=44 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=23 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
n=10 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
n=43 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
n=24 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Medically-Attended Events (MAEs), Adverse Events of Specific Interest (AESIs)/ Potential Immune Mediated Diseases (pIMDs) and Adverse Events (AEs) of Special Interest
MAEs
|
4 Participants
|
11 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects Reporting Medically-Attended Events (MAEs), Adverse Events of Specific Interest (AESIs)/ Potential Immune Mediated Diseases (pIMDs) and Adverse Events (AEs) of Special Interest
AESIs / pIMDs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects Reporting Medically-Attended Events (MAEs), Adverse Events of Specific Interest (AESIs)/ Potential Immune Mediated Diseases (pIMDs) and Adverse Events (AEs) of Special Interest
AEs of special interest
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 28Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.
SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=10 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=44 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=23 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
n=10 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
n=43 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
n=24 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Month 6Population: The analysis was performed on the Total Vaccinated Cohort which included all subjects with study vaccine administered.
SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Fluarix 6-11 Months Group
n=10 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=44 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=23 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
n=10 Participants
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
n=43 Participants
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
n=24 Participants
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Fluarix All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
|
Havrix Junior All Ages Group
Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
Adverse Events
Fluarix 6-11 Months Group
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Fluarix 12-35 Months Group
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
Fluarix 3-9 Years Group
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Havrix Junior 6-11 Months Group
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Havrix Junior 12-35 Months Group
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Havrix Junior 3-9 Years Group
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluarix 6-11 Months Group
n=10 participants at risk
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=44 participants at risk
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=23 participants at risk
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
n=10 participants at risk
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
n=43 participants at risk
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
n=24 participants at risk
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Head injury
|
10.0%
1/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/44 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/23 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/24 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
2.3%
1/44 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/23 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/24 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
Other adverse events
| Measure |
Fluarix 6-11 Months Group
n=10 participants at risk
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 12-35 Months Group
n=44 participants at risk
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Fluarix 3-9 Years Group
n=23 participants at risk
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
|
Havrix Junior 6-11 Months Group
n=10 participants at risk
Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 12-35 Months Group
n=43 participants at risk
Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
Havrix Junior 3-9 Years Group
n=24 participants at risk
Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
|
|---|---|---|---|---|---|---|
|
General disorders
Pain
|
30.0%
3/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
65.1%
28/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
91.3%
21/23 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
50.0%
5/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
44.2%
19/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
58.3%
14/24 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
|
General disorders
Redness
|
70.0%
7/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
76.7%
33/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
82.6%
19/23 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
20.0%
2/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
34.9%
15/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
37.5%
9/24 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
|
General disorders
Swelling
|
50.0%
5/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
53.5%
23/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
47.8%
11/23 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
10.0%
1/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
23.3%
10/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
20.8%
5/24 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
|
General disorders
Diarrhoea
|
50.0%
5/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
18.6%
8/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
18.2%
2/11 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
20.0%
2/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
16.3%
7/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/2 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
|
General disorders
Drowsiness
|
60.0%
6/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
37.2%
16/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
18.2%
2/11 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
20.0%
2/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
34.9%
15/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/2 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
|
General disorders
Irritability
|
60.0%
6/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
46.5%
20/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
36.4%
4/11 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
50.0%
5/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
32.6%
14/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/2 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
|
General disorders
Loss of Appetite
|
60.0%
6/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
32.6%
14/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
36.4%
4/11 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
30.0%
3/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
14.0%
6/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/2 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
|
General disorders
Fever
|
50.0%
5/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
32.6%
14/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
36.4%
4/11 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
30.0%
3/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
25.6%
11/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/2 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
2/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
20.5%
9/44 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/23 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
14.0%
6/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/24 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
9.1%
4/44 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/23 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
2.3%
1/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/24 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/44 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
8.7%
2/23 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
2.3%
1/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
8.3%
2/24 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/44 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
4.3%
1/23 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
10.0%
1/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
4.7%
2/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
4.2%
1/24 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/44 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/23 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
10.0%
1/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/24 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
|
Infections and infestations
Ear infection
|
10.0%
1/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/44 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/23 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/24 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
|
Gastrointestinal disorders
Lip haemorrhage
|
0.00%
0/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/44 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/23 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
10.0%
1/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/24 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
|
Gastrointestinal disorders
Tooth discolouration
|
10.0%
1/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/44 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/23 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/24 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/44 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/23 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
10.0%
1/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/24 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/44 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
4.3%
1/23 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
10.0%
1/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
4.2%
1/24 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
|
Infections and infestations
Varicella
|
10.0%
1/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/44 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/23 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/24 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
2.3%
1/44 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/23 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
4.7%
2/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/24 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
1/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/44 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
4.3%
1/23 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
2.3%
1/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/24 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
2.3%
1/44 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/23 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/24 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
10.0%
1/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/44 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/23 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/10 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/43 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
0.00%
0/24 • Serious adverse events were assessed throughout the study period (from the beginning of the study up to Month 6). Systematically and non-systematically assessed frequent adverse events (AEs) were assessed during 7 days and 28 days post-vaccination.
The following systematically assessed non-serious AEs were assessed only in subjects aged less than 6 years old: diarrhoea, drowsiness, irritability and loss of appetite. The following systematically assessed non-serious AEs were assessed only in subjects aged above 6 years old: fatigue, gastrointestinal symptoms, headache, myalgia and shivering.
|
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