Trial Outcomes & Findings for Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine (NCT NCT00454987)
NCT ID: NCT00454987
Last Updated: 2020-06-16
Results Overview
The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
288 participants
Primary outcome timeframe
At Year 1
Results posted on
2020-06-16
Participant Flow
Study participant flow also includes data from the booster phase (NCT00258700), as SAEs were collected on all the subjects enrolled in the booster phase, which included subjects enrolled in the current NCT00454987 study.
Only subjects from booster phase who volunteered to participate in the long term follow up at year 1,2\&4 were enrolled at the respective years,leading to higher enrolled subjects at year 2 (386) compared to year 1 (288)
Participant milestones
| Measure |
Menitorix Group
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Booster Period (NCT00258700)
STARTED
|
359
|
117
|
0
|
|
Booster Period (NCT00258700)
COMPLETED
|
357
|
116
|
0
|
|
Booster Period (NCT00258700)
NOT COMPLETED
|
2
|
1
|
0
|
|
Year 1 (NCT00454987)
STARTED
|
221
|
67
|
0
|
|
Year 1 (NCT00454987)
COMPLETED
|
221
|
67
|
0
|
|
Year 1 (NCT00454987)
NOT COMPLETED
|
0
|
0
|
0
|
|
Year 2 (NCT00454987)
STARTED
|
235
|
77
|
74
|
|
Year 2 (NCT00454987)
COMPLETED
|
235
|
77
|
74
|
|
Year 2 (NCT00454987)
NOT COMPLETED
|
0
|
0
|
0
|
|
Year 4 (NCT00454987)
STARTED
|
206
|
62
|
0
|
|
Year 4 (NCT00454987)
COMPLETED
|
206
|
62
|
0
|
|
Year 4 (NCT00454987)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Menitorix Group
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Booster Period (NCT00258700)
Adverse Event
|
1
|
0
|
0
|
|
Booster Period (NCT00258700)
Withdrawal by Subject
|
0
|
1
|
0
|
|
Booster Period (NCT00258700)
Lost to Follow-up
|
1
|
0
|
0
|
Baseline Characteristics
Age corresponds to year 1 data
Baseline characteristics by cohort
| Measure |
Menitorix Group
n=359 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=117 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
n=74 Participants
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
Total
n=550 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
12.8 Months
STANDARD_DEVIATION 0.75 • n=359 Participants • Data presented corresponds to booster phase
|
12.8 Months
STANDARD_DEVIATION 0.78 • n=117 Participants • Data presented corresponds to booster phase
|
40.5 Months
STANDARD_DEVIATION 0.71 • n=74 Participants • Baseline characteristic corresponds to year 2
|
12.8 Months
STANDARD_DEVIATION 0.76 • n=476 Participants • Data presented corresponds to booster phase
|
|
Sex: Female, Male
Female
|
179 Participants
n=359 Participants • Data presented corresponds to booster phase
|
62 Participants
n=117 Participants • Data presented corresponds to booster phase
|
28 Participants
n=74 Participants • Data presented for year 2
|
241 Participants
n=476 Participants • Data presented corresponds to booster phase
|
|
Sex: Female, Male
Male
|
180 Participants
n=359 Participants • Data presented corresponds to booster phase
|
55 Participants
n=117 Participants • Data presented corresponds to booster phase
|
46 Participants
n=74 Participants • Data presented for year 2
|
235 Participants
n=476 Participants • Data presented corresponds to booster phase
|
PRIMARY outcome
Timeframe: At Year 1Population: The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had available assay results for at least one tested antigen at Year 1.
The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.
Outcome measures
| Measure |
Menitorix Group
n=204 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=64 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8
rSBA-MenC PIV (M12)
|
178 Subjects
|
41 Subjects
|
—
|
|
Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8
rSBA-MenC (Pre-Primary)
|
12 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8
rSBA-MenC (Post-Primary)
|
200 Subjects
|
63 Subjects
|
—
|
|
Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8
rSBA-MenC (Pre-Booster)
|
163 Subjects
|
39 Subjects
|
—
|
|
Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8
rSBA-MenC (Post-Booster)
|
201 Subjects
|
61 Subjects
|
—
|
PRIMARY outcome
Timeframe: At Year 1Population: The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had available assay results for at least one tested antigen at Year 1.
The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.
Outcome measures
| Measure |
Menitorix Group
n=204 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=64 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
rSBA-MenC (Pre-Primary)
|
3 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
rSBA-MenC (Post-Booster)
|
199 Subjects
|
56 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
rSBA-MenC PIV (M12)
|
109 Subjects
|
17 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
rSBA-MenC (Post-Primary)
|
189 Subjects
|
63 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
rSBA-MenC (Pre-Booster)
|
94 Subjects
|
19 Subjects
|
—
|
PRIMARY outcome
Timeframe: At Year 1Population: The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had available assay results for at least one tested antigen at Year 1.
Antibody concentrations for the serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Outcome measures
| Measure |
Menitorix Group
n=204 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=64 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
rSBA-MenC Antibody Titers
rSBA-MenC (Post-Primary)
|
624.7 Titre
Interval 530.7 to 735.4
|
1000.0 Titre
Interval 778.8 to 1284.2
|
—
|
|
rSBA-MenC Antibody Titers
rSBA-MenC (Pre-Booster)
|
67.1 Titre
Interval 52.8 to 85.3
|
32.4 Titre
Interval 20.3 to 51.6
|
—
|
|
rSBA-MenC Antibody Titers
rSBA-MenC PIV (M12)
|
123.0 Titre
Interval 98.9 to 153.0
|
35.7 Titre
Interval 23.4 to 54.5
|
—
|
|
rSBA-MenC Antibody Titers
rSBA-MenC (Pre-Primary)
|
4.8 Titre
Interval 4.3 to 5.3
|
4.3 Titre
Interval 3.9 to 4.8
|
—
|
|
rSBA-MenC Antibody Titers
rSBA-MenC (Post-Booster)
|
2540.3 Titre
Interval 2058.0 to 3135.5
|
517.4 Titre
Interval 346.7 to 772.0
|
—
|
PRIMARY outcome
Timeframe: At Year 2Population: The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2.
The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.
Outcome measures
| Measure |
Menitorix Group
n=228 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=76 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥1:8
rSBA-MenC (Pre-Booster)
|
175 Subjects
|
48 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥1:8
rSBA-MenC (Post-Booster M1)
|
227 Subjects
|
73 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥1:8
rSBA-MenC (Post-Booster M12)
|
164 Subjects
|
37 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥1:8
rSBA-MenC (Pre-Primary)
|
16 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥1:8
rSBA-MenC (Post-Primary)
|
222 Subjects
|
73 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥1:8
rSBA-MenC (Post-Booster M24)
|
147 Subjects
|
30 Subjects
|
—
|
PRIMARY outcome
Timeframe: At Year 2Population: The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.
The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.
Outcome measures
| Measure |
Menitorix Group
n=68 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 for Meningitec+Hiberix Group
|
30 Subjects
|
—
|
—
|
PRIMARY outcome
Timeframe: At Year 2Population: The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2.
The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.
Outcome measures
| Measure |
Menitorix Group
n=228 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=76 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
rSBA-MenC (Pre-Primary)
|
5 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
rSBA-MenC (Post-Primary)
|
208 Subjects
|
73 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
rSBA-MenC (Pre-Booster)
|
96 Subjects
|
22 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
rSBA-MenC (Post-Booster M24)
|
86 Subjects
|
10 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
rSBA-MenC (Post-Booster M1)
|
225 Subjects
|
66 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
rSBA-MenC (Post-Booster M12)
|
98 Subjects
|
15 Subjects
|
—
|
PRIMARY outcome
Timeframe: At Year 2Population: The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.
The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.
Outcome measures
| Measure |
Menitorix Group
n=68 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 for Meningitec+Hiberix Group
|
11 Subjects
|
—
|
—
|
PRIMARY outcome
Timeframe: At Year 2Population: The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2.
Antibody concentrations for anti-serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers below the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Outcome measures
| Measure |
Menitorix Group
n=228 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=76 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
rSBA-MenC Antibody Titers
rSBA-MenC (Post-Booster M1)
|
2320.8 Titer
Interval 1926.2 to 2796.2
|
520.9 Titer
Interval 367.9 to 737.6
|
—
|
|
rSBA-MenC Antibody Titers
rSBA-MenC (Post-Booster M12)
|
122.3 Titer
Interval 97.5 to 153.4
|
35.9 Titer
Interval 22.9 to 56.0
|
—
|
|
rSBA-MenC Antibody Titers
rSBA-MenC (Pre-Primary)
|
5.0 Titer
Interval 4.4 to 5.6
|
4.2 Titer
Interval 3.9 to 4.5
|
—
|
|
rSBA-MenC Antibody Titers
rSBA-MenC (Post-Primary)
|
592.3 Titer
Interval 507.3 to 691.5
|
1075.6 Titer
Interval 859.8 to 1345.5
|
—
|
|
rSBA-MenC Antibody Titers
rSBA-MenC (Pre-Booster)
|
58.6 Titer
Interval 46.4 to 73.9
|
35.0 Titer
Interval 23.1 to 53.0
|
—
|
|
rSBA-MenC Antibody Titers
rSBA-MenC (Post-Booster M24)
|
48.0 Titer
Interval 36.8 to 62.6
|
14.4 Titer
Interval 9.7 to 21.6
|
—
|
PRIMARY outcome
Timeframe: At Year 2Population: The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.
Antibody concentrations for anti-serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Outcome measures
| Measure |
Menitorix Group
n=68 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
rSBA-MenC Antibody Titers for Meningitec+Hiberix Group
|
15.9 Titer
Interval 10.3 to 24.3
|
—
|
—
|
PRIMARY outcome
Timeframe: At Year 4Population: The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4.
The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:8, resulting in 50% inhibition.
Outcome measures
| Measure |
Menitorix Group
n=195 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=58 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8
rSBA-MenC (Post-Boost M48)
|
115 Subjects
|
26 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8
rSBA-MenC (Pre-Primary)
|
10 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8
rSBA-MenC (Post-Primary)
|
192 Subjects
|
55 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8
rSBA-MenC (Pre-Boost)
|
156 Subjects
|
34 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8
rSBA-MenC (Post-Boost M1)
|
194 Subjects
|
56 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8
rSBA-MenC (Post-Boost M12)
|
148 Subjects
|
30 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8
rSBA-MenC (Post-Boost M24)
|
123 Subjects
|
20 Subjects
|
—
|
PRIMARY outcome
Timeframe: At Year 4Population: The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4.
The anti-meningococcal serogroup C activity was determined using a serum bactericidal test. The cut-off of the assay is a dilution of 1:128, resulting in 50% inhibition.
Outcome measures
| Measure |
Menitorix Group
n=195 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=58 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
rSBA-MenC (Pre-Primary)
|
2 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
rSBA-MenC (Post-Primary)
|
182 Subjects
|
55 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
rSBA-MenC (Post-Boost M12)
|
88 Subjects
|
11 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
rSBA-MenC (Post-Boost M24)
|
78 Subjects
|
6 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
rSBA-MenC (Post-Boost M48)
|
58 Subjects
|
5 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
rSBA-MenC (Pre-Boost)
|
87 Subjects
|
17 Subjects
|
—
|
|
Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
rSBA-MenC (Post-Boost M1)
|
193 Subjects
|
50 Subjects
|
—
|
PRIMARY outcome
Timeframe: At Year 4Population: The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4.
Antibody concentrations for anti-serogroup C serum bactericidal assay using baby rabbit complement were expressed as geometric mean titers (GMT) with 95% confidence intervals (CI). Titers bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Outcome measures
| Measure |
Menitorix Group
n=195 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=58 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
rSBA-MenC Antibody Titers
rSBA-MenC (Pre-Boost)
|
64.3 Titer
Interval 50.3 to 82.4
|
30.8 Titer
Interval 18.8 to 50.4
|
—
|
|
rSBA-MenC Antibody Titers
rSBA-MenC (Pre-Primary)
|
4.7 Titer
Interval 4.2 to 5.2
|
4.2 Titer
Interval 3.9 to 4.6
|
—
|
|
rSBA-MenC Antibody Titers
rSBA-MenC (Post-Primary)
|
616.1 Titer
Interval 521.3 to 728.2
|
983.9 Titer
Interval 742.6 to 1303.7
|
—
|
|
rSBA-MenC Antibody Titers
rSBA-MenC (Post-Boost M1)
|
2537.0 Titer
Interval 2071.9 to 3106.5
|
507.0 Titer
Interval 338.3 to 759.8
|
—
|
|
rSBA-MenC Antibody Titers
rSBA-MenC (Post-Boost M12)
|
124.1 Titer
Interval 97.5 to 158.0
|
30.6 Titer
Interval 18.7 to 50.1
|
—
|
|
rSBA-MenC Antibody Titers
rSBA-MenC (Post-Boost M24)
|
47.9 Titer
Interval 35.7 to 64.3
|
12.1 Titer
Interval 7.7 to 18.8
|
—
|
|
rSBA-MenC Antibody Titers
rSBA-MenC (Post-Boost M48)
|
30.4 Titer
Interval 22.9 to 40.4
|
11.3 Titer
Interval 7.7 to 16.5
|
—
|
PRIMARY outcome
Timeframe: At Year 1Population: The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had available assay results for at least one tested antigen at Year 1.
The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Outcome measures
| Measure |
Menitorix Group
n=206 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=64 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL)
Anti-PRP ≥ 0.15 µg/mL (Pre-Primary)
|
84 Subjects
|
25 Subjects
|
—
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL)
Anti-PRP ≥ 1.0 µg/mL (Post-Boost)
|
120 Subjects
|
19 Subjects
|
—
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL)
Anti-PRP ≥ 0.15 µg/mL PIV (M12)
|
203 Subjects
|
63 Subjects
|
—
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL)
Anti-PRP ≥ 1.0 µg/mL PIV (M12)
|
188 Subjects
|
52 Subjects
|
—
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL)
Anti-PRP ≥ 1.0 µg/mL (Pre-Primary)
|
204 Subjects
|
58 Subjects
|
—
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL)
Anti-PRP ≥ 0.15 µg/mL (Post-Primary)
|
199 Subjects
|
45 Subjects
|
—
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL)
Anti-PRP ≥ 1.0 µg/mL (Post-Primary)
|
203 Subjects
|
63 Subjects
|
—
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL)
Anti-PRP ≥ 0.15 µg/mL (Pre-Boost)
|
198 Subjects
|
63 Subjects
|
—
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL)
Anti-PRP ≥ 1.0 µg/mL (Pre-Boost)
|
20 Subjects
|
11 Subjects
|
—
|
|
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibodies Equal to or Above 0.15 Micrograms Per Milliliter (µg/mL) and Equal to or Above 1 Micrograms Per Milliliter (µg/mL)
Anti-PRP ≥ 0.15 µg/mL (Post-Boost)
|
198 Subjects
|
43 Subjects
|
—
|
PRIMARY outcome
Timeframe: At Year 1Population: The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had available assay results for at least one tested antigen at Year 1.
Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Outcome measures
| Measure |
Menitorix Group
n=206 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=64 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Concentration of Anti-PRP Antibodies
Anti-PRP (Pre-Boost)
|
1.293 µg/mL
Interval 1.095 to 1.528
|
0.441 µg/mL
Interval 0.309 to 0.627
|
—
|
|
Concentration of Anti-PRP Antibodies
Anti-PRP (Pre-Primary)
|
0.160 µg/mL
Interval 0.137 to 0.186
|
0.178 µg/mL
Interval 0.13 to 0.243
|
—
|
|
Concentration of Anti-PRP Antibodies
Anti-PRP (Post-Primary)
|
12.413 µg/mL
Interval 10.688 to 14.417
|
2.473 µg/mL
Interval 1.557 to 3.928
|
—
|
|
Concentration of Anti-PRP Antibodies
Anti-PRP (Post-Boost)
|
88.667 µg/mL
Interval 74.609 to 105.373
|
39.024 µg/mL
Interval 30.588 to 49.786
|
—
|
|
Concentration of Anti-PRP Antibodies
Anti-PRP PIV (M12)
|
7.153 µg/mL
Interval 6.029 to 8.486
|
3.162 µg/mL
Interval 2.316 to 4.318
|
—
|
PRIMARY outcome
Timeframe: At Year 2Population: The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2.
The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Outcome measures
| Measure |
Menitorix Group
n=230 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=75 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 0.15 µg/mL (Pre-Primary)
|
93 Subjects
|
30 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 0.15 µg/mL (Post-Primary)
|
227 Subjects
|
66 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 1.0 µg/mL (Post-Primary)
|
222 Subjects
|
52 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 0.15 µg/mL (Post-Boost M12)
|
182 Subjects
|
57 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 1.0 µg/mL (Post-Boost M12)
|
172 Subjects
|
48 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 0.15 µg/mL (Post-Boost M24)
|
227 Subjects
|
74 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 1.0 µg/mL (Pre-Primary)
|
18 Subjects
|
9 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 0.15 µg/mL (Pre-Boost)
|
222 Subjects
|
53 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 1.0 µg/mL (Pre-Boost)
|
134 Subjects
|
21 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 0.15 µg/mL (Post-Boost M1)
|
228 Subjects
|
75 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 1.0 µg/mL (Post-Boost M1)
|
228 Subjects
|
75 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 1.0 µg/mL (Post-Boost M24)
|
203 Subjects
|
56 Subjects
|
—
|
PRIMARY outcome
Timeframe: At Year 2Population: The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.
The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Outcome measures
| Measure |
Menitorix Group
n=72 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Number of Subjects With Anti-PRP Antibodies ≥0.15 µg/mL and ≥1 µg/mL for Meningitec+Hiberix Group
Anti-PRP ≥ 0.15 µg/mL (Aged 40-43 mths)
|
62 Subjects
|
—
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥0.15 µg/mL and ≥1 µg/mL for Meningitec+Hiberix Group
Anti-PRP ≥ 1.0 µg/mL (Aged 40-43 mths)
|
28 Subjects
|
—
|
—
|
PRIMARY outcome
Timeframe: At Year 2Population: The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2.
Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations below the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Outcome measures
| Measure |
Menitorix Group
n=230 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=75 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Concentration of Anti-PRP Antibodies
Anti-PRP (Pre-Primary)
|
0.153 µg/mL
Interval 0.134 to 0.176
|
0.163 µg/mL
Interval 0.125 to 0.213
|
—
|
|
Concentration of Anti-PRP Antibodies
Anti-PRP (Post-Primary)
|
12.794 µg/mL
Interval 11.159 to 14.669
|
2.396 µg/mL
Interval 1.58 to 3.635
|
—
|
|
Concentration of Anti-PRP Antibodies
Anti-PRP (Pre-Boost)
|
1.260 µg/mL
Interval 1.08 to 1.469
|
0.425 µg/mL
Interval 0.31 to 0.582
|
—
|
|
Concentration of Anti-PRP Antibodies
Anti-PRP (Post-Boost M1)
|
91.981 µg/mL
Interval 78.7 to 107.503
|
44.002 µg/mL
Interval 34.546 to 56.048
|
—
|
|
Concentration of Anti-PRP Antibodies
Anti-PRP (Post-Boost M12)
|
7.107 µg/mL
Interval 5.931 to 8.516
|
3.456 µg/mL
Interval 2.488 to 4.799
|
—
|
|
Concentration of Anti-PRP Antibodies
Anti-PRP (Post-Boost M24)
|
4.790 µg/mL
Interval 4.065 to 5.644
|
2.339 µg/mL
Interval 1.798 to 3.042
|
—
|
PRIMARY outcome
Timeframe: At Year 2Population: The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.
Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations below the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Outcome measures
| Measure |
Menitorix Group
n=72 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Concentration of Anti-PRP Antibodies for Meningitec+Hiberix Group
|
0.668 µg/mL
Interval 0.467 to 0.956
|
—
|
—
|
PRIMARY outcome
Timeframe: At Year 4Population: The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4.
The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Outcome measures
| Measure |
Menitorix Group
n=197 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=58 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 0.15 µg/mL (Pre-Primary)
|
77 Subjects
|
24 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 1.0 µg/mL (Pre-Primary)
|
14 Subjects
|
9 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 0.15 µg/mL (Post-Primary)
|
196 Subjects
|
48 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 1.0 µg/mL (Post-Primary)
|
191 Subjects
|
33 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 0.15 µg/mL (Pre-Boost)
|
191 Subjects
|
38 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 1.0 µg/mL (Pre-Boost)
|
119 Subjects
|
14 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 0.15 µg/mL (Post-Boost M1)
|
195 Subjects
|
57 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 1.0 µg/mL (Post-Boost M1)
|
195 Subjects
|
57 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 0.15 µg/mL (Post-Boost M12)
|
164 Subjects
|
48 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 1.0 µg/mL (Post-Boost M12)
|
157 Subjects
|
40 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 0.15 µg/mL (Post-Boost M24)
|
193 Subjects
|
55 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 1.0 µg/mL (Post-Boost M24)
|
174 Subjects
|
40 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 0.15 µg/mL (Post-Boost M48)
|
197 Subjects
|
58 Subjects
|
—
|
|
Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Anti-PRP ≥ 1.0 µg/mL (Post-Boost M48)
|
171 Subjects
|
36 Subjects
|
—
|
PRIMARY outcome
Timeframe: At Year 4Population: The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4.
Antibody concentrations for anti-polyribosylribitol phosphate were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations below the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Outcome measures
| Measure |
Menitorix Group
n=197 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=58 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Concentration of Anti-PRP Antibodies
Anti-PRP (Pre-Primary)
|
0.149 µg/mL
Interval 0.129 to 0.173
|
0.180 µg/mL
Interval 0.13 to 0.25
|
—
|
|
Concentration of Anti-PRP Antibodies
Anti-PRP (Post-Primary)
|
12.715 µg/mL
Interval 10.945 to 14.771
|
1.776 µg/mL
Interval 1.058 to 2.979
|
—
|
|
Concentration of Anti-PRP Antibodies
Anti-PRP (Pre-Boost)
|
1.276 µg/mL
Interval 1.08 to 1.508
|
0.380 µg/mL
Interval 0.263 to 0.55
|
—
|
|
Concentration of Anti-PRP Antibodies
Anti-PRP (Post-Boost M1)
|
90.101 µg/mL
Interval 76.087 to 106.697
|
39.105 µg/mL
Interval 29.506 to 51.825
|
—
|
|
Concentration of Anti-PRP Antibodies
Anti-PRP (Post-Boost M12)
|
7.455 µg/mL
Interval 6.176 to 8.998
|
3.557 µg/mL
Interval 2.45 to 5.165
|
—
|
|
Concentration of Anti-PRP Antibodies
Anti-PRP (Post-Boost M24)
|
4.928 µg/mL
Interval 4.135 to 5.873
|
2.083 µg/mL
Interval 1.524 to 2.847
|
—
|
|
Concentration of Anti-PRP Antibodies
Anti-PRP (Post-Boost M48)
|
3.824 µg/mL
Interval 3.218 to 4.543
|
1.673 µg/mL
Interval 1.215 to 2.305
|
—
|
PRIMARY outcome
Timeframe: At Year 1Population: The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had available assay results for at least one tested antigen at Year 1.
The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Outcome measures
| Measure |
Menitorix Group
n=206 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=64 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL)
Anti-PSC ≥ 0.3 µg/mL (Pre-Primary)
|
19 Subjects
|
4 Subjects
|
—
|
|
Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL)
Anti-PSC ≥ 2 µg/mL (Pre-Primary)
|
8 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL)
Anti-PSC ≥ 0.3 µg/mL (Post-Primary)
|
202 Subjects
|
63 Subjects
|
—
|
|
Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL)
Anti-PSC ≥ 2 µg/mL (Post-Primary)
|
201 Subjects
|
63 Subjects
|
—
|
|
Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL)
Anti-PSC ≥ 0.3 µg/mL (Pre-Booster)
|
170 Subjects
|
56 Subjects
|
—
|
|
Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL)
Anti-PSC ≥ 2 µg/mL (Pre-Booster)
|
27 Subjects
|
10 Subjects
|
—
|
|
Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL)
Anti-PSC ≥ 0.3 µg/mL (Post-Booster)
|
205 Subjects
|
64 Subjects
|
—
|
|
Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL)
Anti-PSC ≥ 2 µg/mL (Post-Booster)
|
183 Subjects
|
47 Subjects
|
—
|
|
Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL)
Anti-PSC ≥ 0.3 µg/mL (PIV [M12])
|
119 Subjects
|
29 Subjects
|
—
|
|
Number of Subjects With Anti-serogroup C Polysaccharide (Anti-PSC) Antibody Concentrations Equal to or Above 0.3 Micrograms Per Milliliter(µg/mL) and Equal to or Above 2 Micrograms Per Milliliter (µg/mL)
Anti-PSC ≥ 2 µg/mL (PIV [M12])
|
19 Subjects
|
2 Subjects
|
—
|
PRIMARY outcome
Timeframe: At Year 1Population: The ATP cohort for persistence Year 1 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had available assay results for at least one tested antigen at Year 1.
Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Outcome measures
| Measure |
Menitorix Group
n=206 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=64 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Concentration of Anti-PSC Antibodies
Anti-PSC (Pre-Primary)
|
0.18 µg/mL
Interval 0.17 to 0.2
|
0.17 µg/mL
Interval 0.15 to 0.18
|
—
|
|
Concentration of Anti-PSC Antibodies
Anti-PSC (Post-Primary)
|
9.52 µg/mL
Interval 8.68 to 10.45
|
11.20 µg/mL
Interval 9.42 to 13.33
|
—
|
|
Concentration of Anti-PSC Antibodies
Anti-PSC (Pre-Booster)
|
0.77 µg/mL
Interval 0.67 to 0.88
|
0.84 µg/mL
Interval 0.66 to 1.06
|
—
|
|
Concentration of Anti-PSC Antibodies
Anti-PSC (Post-Booster)
|
7.36 µg/mL
Interval 6.46 to 8.39
|
3.51 µg/mL
Interval 2.84 to 4.32
|
—
|
|
Concentration of Anti-PSC Antibodies
Anti-PSC (PIV [M12])
|
0.47 µg/mL
Interval 0.4 to 0.55
|
0.32 µg/mL
Interval 0.26 to 0.4
|
—
|
PRIMARY outcome
Timeframe: At Year 2Population: The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2.
The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Outcome measures
| Measure |
Menitorix Group
n=230 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=76 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 2 µg/mL (Pre-Primary)
|
12 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 0.3 µg/mL (Post-Primary)
|
225 Subjects
|
72 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 2 µg/mL (Post-Primary)
|
224 Subjects
|
72 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 0.3 µg/mL (Pre-Primary)
|
26 Subjects
|
6 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 0.3 µg/mL (Pre-Booster)
|
188 Subjects
|
66 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 2 µg/mL (Pre-Booster)
|
27 Subjects
|
13 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 0.3 µg/mL (Post-Booster [M1]
|
230 Subjects
|
76 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 2 µg/mL (Post-Booster) [M1]
|
210 Subjects
|
59 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 0.3µg/mL (Post-Booster [M12]
|
110 Subjects
|
26 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 2 µg/mL (Post-Booster [M12])
|
16 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥0.3 µg/mL (Post-Booster [M24]
|
76 Subjects
|
17 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 2 µg/mL (Post-Booster [M24])
|
5 Subjects
|
0 Subjects
|
—
|
PRIMARY outcome
Timeframe: At Year 2Population: The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.
The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Outcome measures
| Measure |
Menitorix Group
n=72 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL for Meningitec+Hiberix Group
Anti-PSC ≥ 0.3 µg/mL (Aged 40-43 mths)
|
4 Participants
|
—
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL for Meningitec+Hiberix Group
Anti-PSC ≥2 µg/mL (Aged 40-43 mths)
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At Year 2Population: The ATP cohort for persistence Year 2 included for all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2.
Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Outcome measures
| Measure |
Menitorix Group
n=230 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=76 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Concentration of Anti-PSC Antibodies
Anti-PSC (Pre-Primary)
|
0.20 µg/mL
Interval 0.18 to 0.22
|
0.17 µg/mL
Interval 0.15 to 0.18
|
—
|
|
Concentration of Anti-PSC Antibodies
Anti-PSC (Post-Booster [M12])
|
0.47 µg/mL
Interval 0.4 to 0.55
|
0.32 µg/mL
Interval 0.25 to 0.4
|
—
|
|
Concentration of Anti-PSC Antibodies
Anti-PSC (Post-Primary)
|
9.35 µg/mL
Interval 8.56 to 10.22
|
12.29 µg/mL
Interval 10.5 to 14.39
|
—
|
|
Concentration of Anti-PSC Antibodies
Anti-PSC (Pre-Booster)
|
0.74 µg/mL
Interval 0.65 to 0.84
|
0.87 µg/mL
Interval 0.69 to 1.1
|
—
|
|
Concentration of Anti-PSC Antibodies
Anti-PSC (Post-Booster [M1])
|
7.41 µg/mL
Interval 6.59 to 8.33
|
3.91 µg/mL
Interval 3.19 to 4.79
|
—
|
|
Concentration of Anti-PSC Antibodies
Anti-PSC (Post-Booster [M24])
|
0.25 µg/mL
Interval 0.23 to 0.28
|
0.21 µg/mL
Interval 0.18 to 0.24
|
—
|
PRIMARY outcome
Timeframe: At Year 2Population: The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of Meningitec™ conjugate vaccine and a Hiberix™ vaccine before 8 months of age, with available results for at least one tested antigen at Year 2.
Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Outcome measures
| Measure |
Menitorix Group
n=72 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Concentration of Anti-PSC Antibodies for Meningitec+Hiberix Group
|
0.16 µg/mL
Interval 0.15 to 0.18
|
—
|
—
|
PRIMARY outcome
Timeframe: At Year 4Population: The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4.
The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Outcome measures
| Measure |
Menitorix Group
n=197 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=58 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 0.3 µg/mL (Post-Boost [M12])
|
101 Subjects
|
22 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 2 µg/mL (Post-Boost [M12])
|
15 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 2 µg/mL (Post-Boost [M48])
|
6 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 0.3 µg/mL (Pre-Primary)
|
19 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 2 µg/mL (Pre-Primary)
|
7 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 0.3 µg/mL (Post-Primary)
|
194 Subjects
|
54 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 2 µg/mL (Post-Primary)
|
193 Subjects
|
54 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 0.3 µg/mL (Pre-Boost)
|
163 Subjects
|
52 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 2 µg/mL (Pre-Boost)
|
24 Subjects
|
9 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 0.3 µg/mL (Post-Boost [M1])
|
197 Subjects
|
58 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 2 µg/mL (Post-Boost [M1])
|
179 Subjects
|
43 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 0.3 µg/mL (Post-Boost [M24])
|
69 Subjects
|
10 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 2 µg/mL (Post-Boost [M24])
|
5 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Anti-PSC ≥ 0.3 µg/mL (Post-Boost [M48])
|
38 Subjects
|
4 Subjects
|
—
|
PRIMARY outcome
Timeframe: At Year 4Population: The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4.
Antibody concentrations for anti-polysaccharide C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in µg/mL. Concentrations bellow the cut-off of the test were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Outcome measures
| Measure |
Menitorix Group
n=197 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=58 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Concentration of Anti-PSC Antibodies
Anti-PSC (Post-Boost [M12])
|
0.48 µg/mL
Interval 0.41 to 0.57
|
0.34 µg/mL
Interval 0.26 to 0.45
|
—
|
|
Concentration of Anti-PSC Antibodies
Anti-PSC (Post-Boost [M24])
|
0.27 µg/mL
Interval 0.23 to 0.3
|
0.19 µg/mL
Interval 0.16 to 0.22
|
—
|
|
Concentration of Anti-PSC Antibodies
Anti-PSC (Pre-Primary)
|
0.19 µg/mL
Interval 0.17 to 0.21
|
0.16 µg/mL
Interval 0.15 to 0.18
|
—
|
|
Concentration of Anti-PSC Antibodies
Anti-PSC (Post-Primary)
|
9.41 µg/mL
Interval 8.55 to 10.36
|
11.88 µg/mL
Interval 9.75 to 14.46
|
—
|
|
Concentration of Anti-PSC Antibodies
Anti-PSC (Pre-Boost)
|
0.76 µg/mL
Interval 0.66 to 0.87
|
0.85 µg/mL
Interval 0.66 to 1.09
|
—
|
|
Concentration of Anti-PSC Antibodies
Anti-PSC (Post-Boost [M1])
|
7.46 µg/mL
Interval 6.55 to 8.49
|
3.76 µg/mL
Interval 2.94 to 4.8
|
—
|
|
Concentration of Anti-PSC Antibodies
Anti-PSC (Post-Boost [M48])
|
0.21 µg/mL
Interval 0.19 to 0.23
|
0.17 µg/mL
Interval 0.15 to 0.19
|
—
|
PRIMARY outcome
Timeframe: At Year 2Population: The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2. Persistence of anti-PT, anti-FHA and anti-PRN antibodies were evaluated for the UK subjects of Menitorix group and Meningitec group only
The anti-pertussis toxoid, anti-filamentous haemagglutin, anti-pertactin activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Outcome measures
| Measure |
Menitorix Group
n=67 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=23 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL)
Anti-PT Pre-Primary
|
11 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL)
Anti-PT Post-Primary (M3)
|
63 Subjects
|
20 Subjects
|
—
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL)
Anti-PT Post-Primary (M10)
|
34 Subjects
|
10 Subjects
|
—
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL)
Anti-PT Pre-Boost
|
8 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL)
Anti-FHA Pre-Primary
|
40 Subjects
|
12 Subjects
|
—
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL)
Anti-FHA Post-Primary (M3)
|
63 Subjects
|
20 Subjects
|
—
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL)
Anti-FHA Post-Primary (M10)
|
65 Subjects
|
21 Subjects
|
—
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL)
Anti-FHA Pre-Boost
|
47 Subjects
|
13 Subjects
|
—
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL)
Anti-PRN Pre-Primary
|
22 Subjects
|
4 Subjects
|
—
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL)
Anti-PRN Post-Primary (M3)
|
63 Subjects
|
20 Subjects
|
—
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL)
Anti-PRN Post-Primary (M10)
|
53 Subjects
|
14 Subjects
|
—
|
|
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5.0 ELISA Units Per Milliliter (EL.U/mL)
Anti-PRN Pre-Boost
|
34 Subjects
|
7 Subjects
|
—
|
PRIMARY outcome
Timeframe: At Year 2Population: The ATP cohort for persistence Year 2 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, with available results for at least one tested antigen at Year 2. Persistence of anti-PT, anti-FHA and anti-PRN antibodies were evaluated for the UK subjects of Menitorix group and Meningitec group only
Antibody concentrations for anti-pertussis toxoid, anti-filamentous haemagglutin and anti-pertactin C were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in EL.U/mL.
Outcome measures
| Measure |
Menitorix Group
n=67 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=23 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-PT Pre-Primary
|
3.2 EL.U/mL
Interval 2.8 to 3.7
|
3.3 EL.U/mL
Interval 2.4 to 4.6
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-PT Post-Primary (M3)
|
44.8 EL.U/mL
Interval 39.1 to 51.2
|
40.1 EL.U/mL
Interval 31.7 to 50.8
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-PT Post-Primary (M10)
|
4.9 EL.U/mL
Interval 4.1 to 5.9
|
4.5 EL.U/mL
Interval 3.3 to 6.1
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-PT Pre-Boost
|
2.9 EL.U/mL
Interval 2.6 to 3.2
|
3.0 EL.U/mL
Interval 2.4 to 3.6
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-FHA Pre-Primary
|
6.5 EL.U/mL
Interval 5.2 to 8.2
|
7.8 EL.U/mL
Interval 4.7 to 13.0
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-FHA Post-Primary (M3)
|
223.5 EL.U/mL
Interval 194.6 to 256.7
|
160.2 EL.U/mL
Interval 123.1 to 208.6
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-FHA Post-Primary (M10)
|
30.4 EL.U/mL
Interval 25.7 to 35.9
|
25.8 EL.U/mL
Interval 19.0 to 34.9
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-FHA Pre-Boost
|
15.1 EL.U/mL
Interval 9.5 to 24.0
|
20.3 EL.U/mL
Interval 8.0 to 51.8
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-PRN Pre-Primary
|
4.2 EL.U/mL
Interval 3.4 to 5.2
|
3.1 EL.U/mL
Interval 2.5 to 3.9
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-PRN Post-Primary (M3)
|
116.3 EL.U/mL
Interval 93.7 to 144.5
|
46.1 EL.U/mL
Interval 31.0 to 68.5
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-PRN Post-Primary (M10)
|
12.5 EL.U/mL
Interval 9.5 to 16.2
|
6.6 EL.U/mL
Interval 4.4 to 9.9
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-PRN Pre-Boost
|
5.9 EL.U/mL
Interval 4.5 to 7.7
|
4.3 EL.U/mL
Interval 2.8 to 6.5
|
—
|
PRIMARY outcome
Timeframe: At Year 4Population: The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4.
The anti-pertussis toxoid, anti-filamentous haemagglutin, anti-pertactin activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Outcome measures
| Measure |
Menitorix Group
n=44 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=14 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL
Anti-FHA Pre-Boost ( M32)
|
29 Subjects
|
10 Subjects
|
—
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL
Anti-FHA Post-Boost ( M24)
|
41 Subjects
|
14 Subjects
|
—
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL
Anti-PT Pre-Primary
|
9 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL
Anti-PT Post-Primary (M3)
|
42 Subjects
|
11 Subjects
|
—
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL
Anti-PT Post-Primary (M10)
|
24 Subjects
|
5 Subjects
|
—
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL
Anti-PT Pre-Boost ( M32)
|
6 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL
Anti-PT Post-Boost ( M24)
|
30 Subjects
|
9 Subjects
|
—
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL
Anti-FHA Pre-Primary
|
27 Subjects
|
9 Subjects
|
—
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL
Anti-FHA Post-Primary (M3)
|
42 Subjects
|
11 Subjects
|
—
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL
Anti-FHA Post-Primary (M10)
|
43 Subjects
|
13 Subjects
|
—
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL
Anti-PRN Pre-Primary
|
13 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL
Anti-PRN Post-Primary (M3)
|
42 Subjects
|
11 Subjects
|
—
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL
Anti-PRN Post-Primary (M10)
|
36 Subjects
|
8 Subjects
|
—
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL
Anti-PRN Pre-Boost ( M32)
|
25 Subjects
|
4 Subjects
|
—
|
|
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL
Anti-PRN Post-Boost ( M24)
|
43 Subjects
|
14 Subjects
|
—
|
PRIMARY outcome
Timeframe: At Year 4Population: The ATP cohort for persistence Year 4 included all evaluable subjects who received 3 doses of vaccines in study NCT00258700, who had assay results available for at least one tested antigen at Year 4.
Antibody concentrations for anti-pertussis toxoid, anti-filamentous haemagglutin and anti-pertactin were expressed as geometric mean concentrations (GMC) with 95% confidence intervals (CI), given in EL.U/mL.
Outcome measures
| Measure |
Menitorix Group
n=44 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=14 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-PT Post-Primary (M3)
|
45.2 EL.U/mL
Interval 37.2 to 54.8
|
36.5 EL.U/mL
Interval 26.1 to 51.1
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-PT Post-Primary (M10)
|
5.1 EL.U/mL
Interval 4.1 to 6.4
|
3.9 EL.U/mL
Interval 2.7 to 5.6
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-PT Post-Boost ( M24)
|
8.2 EL.U/mL
Interval 6.1 to 10.9
|
7.2 EL.U/mL
Interval 3.9 to 13.4
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-FHA Pre-Boost ( M32)
|
16.7 EL.U/mL
Interval 9.0 to 30.9
|
33.1 EL.U/mL
Interval 9.6 to 113.8
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-FHA Post-Boost ( M24)
|
164.7 EL.U/mL
Interval 119.4 to 227.1
|
66.8 EL.U/mL
Interval 43.8 to 101.7
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-PRN Post-Primary (M3)
|
135.6 EL.U/mL
Interval 106.0 to 173.4
|
50.4 EL.U/mL
Interval 26.0 to 97.6
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-PRN Post-Primary (M10)
|
12.2 EL.U/mL
Interval 8.9 to 16.7
|
5.6 EL.U/mL
Interval 3.6 to 8.8
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-PRN Pre-Boost ( M32)
|
6.6 EL.U/mL
Interval 4.5 to 9.5
|
4.9 EL.U/mL
Interval 2.4 to 9.8
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-PRN Post-Boost ( M24)
|
102.8 EL.U/mL
Interval 67.1 to 157.3
|
23.4 EL.U/mL
Interval 15.1 to 36.2
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-PT Pre-Boost ( M32)
|
3.0 EL.U/mL
Interval 2.5 to 3.5
|
3.1 EL.U/mL
Interval 2.3 to 4.1
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-FHA Pre-Primary
|
7.2 EL.U/mL
Interval 5.2 to 10.0
|
9.1 EL.U/mL
Interval 4.7 to 17.6
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-FHA Post-Primary (M3)
|
229.9 EL.U/mL
Interval 188.5 to 280.4
|
169.8 EL.U/mL
Interval 127.0 to 227.0
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-FHA Post-Primary (M10)
|
27.2 EL.U/mL
Interval 22.1 to 33.5
|
22.8 EL.U/mL
Interval 15.6 to 33.3
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-PRN Pre-Primary
|
3.9 EL.U/mL
Interval 3.1 to 4.9
|
3.1 EL.U/mL
Interval 2.4 to 4.1
|
—
|
|
Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Anti-PT Pre-Primary
|
3.4 EL.U/mL
Interval 2.8 to 4.1
|
3.4 EL.U/mL
Interval 2.1 to 5.5
|
—
|
PRIMARY outcome
Timeframe: Up to Month 12 (Booster vaccination)Population: The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study NCT00258700.
A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.
Outcome measures
| Measure |
Menitorix Group
n=359 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=117 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
0 Subjects
|
0 Subjects
|
—
|
PRIMARY outcome
Timeframe: Up to Month 24 (Booster vaccination)Population: The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study NCT00258700.
A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.
Outcome measures
| Measure |
Menitorix Group
n=359 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=117 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Number of Subjects With SAE(s)
|
0 Subjects
|
0 Subjects
|
—
|
PRIMARY outcome
Timeframe: Up to Month 48 (Booster vaccination)Population: The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study NCT00258700.
A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.
Outcome measures
| Measure |
Menitorix Group
n=359 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=117 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Number of Subjects With SAE(s)
|
1 Subjects
|
0 Subjects
|
—
|
PRIMARY outcome
Timeframe: Within (31-Days) at Year 2Population: The Total Cohort Year 2 included all vaccinated subjects in the booster study NCT00258700, who came back for the Year 2 follow-up and also all subjects of Meningitec+Hiberix Group who were enrolled and vaccinated at Visit 2 in study NCT00454987 (i.e. 40-43 months of age).
A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.
Outcome measures
| Measure |
Menitorix Group
n=70 Participants
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=23 Participants
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
n=72 Participants
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Number of Subjects With SAE(s)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
Adverse Events
Menitorix Group
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Meningitec Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Meningitec+Hiberix Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Menitorix Group
n=359 participants at risk
Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec Group
n=117 participants at risk
Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
|
Meningitec+Hiberix Group
n=74 participants at risk
Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
This group was added only at year 2 in UK (Meningitec+Hiberix Group) to comply with UK Hib Catch-up vaccination programme.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.4%
1/70 • SAEs: from booster study NCT00258700 until the end of the persistence study (M48).
No information about unsolicited adverse events was collected during this study. SAEs were collected on the total number of subjects in the NCT00258700 study (476), which included the subjects enrolled in this NCT00454987 study.
|
0.00%
0/23 • SAEs: from booster study NCT00258700 until the end of the persistence study (M48).
No information about unsolicited adverse events was collected during this study. SAEs were collected on the total number of subjects in the NCT00258700 study (476), which included the subjects enrolled in this NCT00454987 study.
|
0.00%
0/74 • SAEs: from booster study NCT00258700 until the end of the persistence study (M48).
No information about unsolicited adverse events was collected during this study. SAEs were collected on the total number of subjects in the NCT00258700 study (476), which included the subjects enrolled in this NCT00454987 study.
|
|
General disorders
Pyrexia
|
0.28%
1/359 • SAEs: from booster study NCT00258700 until the end of the persistence study (M48).
No information about unsolicited adverse events was collected during this study. SAEs were collected on the total number of subjects in the NCT00258700 study (476), which included the subjects enrolled in this NCT00454987 study.
|
0.00%
0/117 • SAEs: from booster study NCT00258700 until the end of the persistence study (M48).
No information about unsolicited adverse events was collected during this study. SAEs were collected on the total number of subjects in the NCT00258700 study (476), which included the subjects enrolled in this NCT00454987 study.
|
0.00%
0/74 • SAEs: from booster study NCT00258700 until the end of the persistence study (M48).
No information about unsolicited adverse events was collected during this study. SAEs were collected on the total number of subjects in the NCT00258700 study (476), which included the subjects enrolled in this NCT00454987 study.
|
Other adverse events
Adverse event data not reported
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