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Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00454987
Recruitment Status : Completed
First Posted : April 2, 2007
Results First Posted : December 16, 2015
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Haemophilus Influenzae Type b
Neisseria Meningitidis
Neisseria Meningitidis-Haemophilus Influenzae Type b Vaccine
Interventions Biological: Menitorix
Biological: Infanrix IPV
Enrollment 288
Recruitment Details 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.
Pre-assignment Details 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)
Arm/Group Title Menitorix Group Meningitec Group Meningitec+Hiberix Group
Hide Arm/Group Description 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. 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.

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.

Period Title: Booster Period (NCT00258700)
Started 359 117 0
Completed 357 116 0
Not Completed 2 1 0
Reason Not Completed
Adverse Event             1             0             0
Withdrawal by Subject             0             1             0
Lost to Follow-up             1             0             0
Period Title: Year 1 (NCT00454987)
Started 221 67 0
Completed 221 67 0
Not Completed 0 0 0
Period Title: Year 2 (NCT00454987)
Started 235 77 74
Completed 235 77 74
Not Completed 0 0 0
Period Title: Year 4 (NCT00454987)
Started 206 62 0
Completed 206 62 0
Not Completed 0 0 0
Arm/Group Title Menitorix Group Meningitec Group Meningitec+Hiberix Group Total
Hide Arm/Group Description 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. 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.

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 of all reporting groups
Overall Number of Baseline Participants 359 117 74 550
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 221 participants 67 participants 0 participants 288 participants
27.9  (0.97) 27.7  (0.68) 27.85  (0.91)
[1]
Measure Analysis Population Description: Age corresponds to year 1 data
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 235 participants 77 participants 74 participants 386 participants
40.6  (0.76) 40.6  (0.74) 40.5  (0.71) 40.5  (0.73)
[1]
Measure Analysis Population Description: Baseline characteristic corresponds to year 2
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 206 participants 62 participants 0 participants 268 participants
61.1  (1.03) 61.0  (1.25) 61.0  (1.14)
[1]
Measure Analysis Population Description: Data presented for year 4
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 359 participants 117 participants 0 participants 476 participants
12.8  (0.75) 12.8  (0.78) 12.8  (0.76)
[1]
Measure Analysis Population Description: Data presented corresponds to booster phase
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants 67 participants 0 participants 288 participants
Female
114
  51.6%
33
  49.3%
147
  51.0%
Male
107
  48.4%
34
  50.7%
141
  49.0%
[1]
Measure Analysis Population Description: Data presented correspond to year 1
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 235 participants 77 participants 74 participants 386 participants
Female
117
  49.8%
37
  48.1%
28
  37.8%
182
  47.2%
Male
118
  50.2%
40
  51.9%
46
  62.2%
204
  52.8%
[1]
Measure Analysis Population Description: Data presented for year 2
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 206 participants 62 participants 0 participants 268 participants
Female
102
  49.5%
31
  50.0%
133
  49.6%
Male
104
  50.5%
31
  50.0%
135
  50.4%
[1]
Measure Analysis Population Description: Data presented for year 4
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 359 participants 117 participants 0 participants 476 participants
Female
179
  49.9%
62
  53.0%
241
  50.6%
Male
180
  50.1%
55
  47.0%
235
  49.4%
[1]
Measure Analysis Population Description: Data presented corresponds to booster phase
1.Primary Outcome
Title Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8
Hide Description 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.
Time Frame At Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 204 64
Measure Type: Number
Unit of Measure: Subjects
rSBA-MenC (Pre-Primary) Number Analyzed 204 participants 60 participants
12 3
rSBA-MenC (Post-Primary) Number Analyzed 202 participants 63 participants
200 63
rSBA-MenC (Pre-Booster) Number Analyzed 202 participants 62 participants
163 39
rSBA-MenC (Post-Booster) Number Analyzed 203 participants 64 participants
201 61
rSBA-MenC PIV (M12) Number Analyzed 200 participants 59 participants
178 41
2.Primary Outcome
Title Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
Hide Description 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.
Time Frame At Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 204 64
Measure Type: Number
Unit of Measure: Subjects
rSBA-MenC (Pre-Primary) Number Analyzed 204 participants 60 participants
3 0
rSBA-MenC (Post-Primary) Number Analyzed 202 participants 63 participants
189 63
rSBA-MenC (Pre-Booster) Number Analyzed 202 participants 62 participants
94 19
rSBA-MenC (Post-Booster) Number Analyzed 203 participants 64 participants
199 56
rSBA-MenC PIV (M12) Number Analyzed 200 participants 59 participants
109 17
3.Primary Outcome
Title rSBA-MenC Antibody Titers
Hide Description 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.
Time Frame At Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 204 64
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titre
rSBA-MenC (Pre-Primary) Number Analyzed 204 participants 60 participants
4.8
(4.3 to 5.3)
4.3
(3.9 to 4.8)
rSBA-MenC (Post-Primary) Number Analyzed 202 participants 63 participants
624.7
(530.7 to 735.4)
1000.0
(778.8 to 1284.2)
rSBA-MenC (Pre-Booster) Number Analyzed 202 participants 62 participants
67.1
(52.8 to 85.3)
32.4
(20.3 to 51.6)
rSBA-MenC (Post-Booster) Number Analyzed 203 participants 64 participants
2540.3
(2058.0 to 3135.5)
517.4
(346.7 to 772.0)
rSBA-MenC PIV (M12) Number Analyzed 200 participants 59 participants
123.0
(98.9 to 153.0)
35.7
(23.4 to 54.5)
4.Primary Outcome
Title Number of Subjects With rSBA-MenC Antibody Titers ≥1:8
Hide Description 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.
Time Frame At Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 228 76
Measure Type: Number
Unit of Measure: Subjects
rSBA-MenC (Pre-Primary) Number Analyzed 227 participants 70 participants
16 2
rSBA-MenC (Post-Primary) Number Analyzed 224 participants 73 participants
222 73
rSBA-MenC (Pre-Booster) Number Analyzed 226 participants 72 participants
175 48
rSBA-MenC (Post-Booster M1) Number Analyzed 228 participants 76 participants
227 73
rSBA-MenC (Post-Booster M12) Number Analyzed 184 participants 53 participants
164 37
rSBA-MenC (Post-Booster M24) Number Analyzed 219 participants 74 participants
147 30
5.Primary Outcome
Title Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 for Meningitec+Hiberix Group
Hide Description 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.
Time Frame At Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Meningitec+Hiberix Group
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: Subjects
30
6.Primary Outcome
Title Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
Hide Description 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.
Time Frame At Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 228 76
Measure Type: Number
Unit of Measure: Subjects
rSBA-MenC (Pre-Primary) Number Analyzed 227 participants 70 participants
5 0
rSBA-MenC (Post-Primary) Number Analyzed 224 participants 73 participants
208 73
rSBA-MenC (Pre-Booster) Number Analyzed 226 participants 72 participants
96 22
rSBA-MenC (Post-Booster M1) Number Analyzed 228 participants 76 participants
225 66
rSBA-MenC (Post-Booster M12) Number Analyzed 184 participants 53 participants
98 15
rSBA-MenC (Post-Booster M24) Number Analyzed 219 participants 74 participants
86 10
7.Primary Outcome
Title Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 for Meningitec+Hiberix Group
Hide Description 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.
Time Frame At Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Meningitec+Hiberix Group
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: Subjects
11
8.Primary Outcome
Title rSBA-MenC Antibody Titers
Hide Description 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.
Time Frame At Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 228 76
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
rSBA-MenC (Pre-Primary) Number Analyzed 227 participants 70 participants
5.0
(4.4 to 5.6)
4.2
(3.9 to 4.5)
rSBA-MenC (Post-Primary) Number Analyzed 224 participants 73 participants
592.3
(507.3 to 691.5)
1075.6
(859.8 to 1345.5)
rSBA-MenC (Pre-Booster) Number Analyzed 226 participants 72 participants
58.6
(46.4 to 73.9)
35.0
(23.1 to 53.0)
rSBA-MenC (Post-Booster M1) Number Analyzed 228 participants 76 participants
2320.8
(1926.2 to 2796.2)
520.9
(367.9 to 737.6)
rSBA-MenC (Post-Booster M12) Number Analyzed 184 participants 53 participants
122.3
(97.5 to 153.4)
35.9
(22.9 to 56.0)
rSBA-MenC (Post-Booster M24) Number Analyzed 219 participants 74 participants
48.0
(36.8 to 62.6)
14.4
(9.7 to 21.6)
9.Primary Outcome
Title rSBA-MenC Antibody Titers for Meningitec+Hiberix Group
Hide Description 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.
Time Frame At Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Meningitec+Hiberix Group
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 68
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
15.9
(10.3 to 24.3)
10.Primary Outcome
Title Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8
Hide Description 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.
Time Frame At Year 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 195 58
Measure Type: Number
Unit of Measure: Subjects
rSBA-MenC (Pre-Primary) Number Analyzed 194 participants 53 participants
10 2
rSBA-MenC (Post-Primary) Number Analyzed 194 participants 55 participants
192 55
rSBA-MenC (Pre-Boost) Number Analyzed 195 participants 55 participants
156 34
rSBA-MenC (Post-Boost M1) Number Analyzed 195 participants 58 participants
194 56
rSBA-MenC (Post-Boost M12) Number Analyzed 166 participants 45 participants
148 30
rSBA-MenC (Post-Boost M24) Number Analyzed 187 participants 56 participants
123 20
rSBA-MenC (Post-Boost M48) Number Analyzed 194 participants 58 participants
115 26
11.Primary Outcome
Title Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
Hide Description 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.
Time Frame At Year 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 195 58
Measure Type: Number
Unit of Measure: Subjects
rSBA-MenC (Pre-Primary) Number Analyzed 194 participants 53 participants
2 0
rSBA-MenC (Post-Primary) Number Analyzed 194 participants 55 participants
182 55
rSBA-MenC (Pre-Boost) Number Analyzed 195 participants 55 participants
87 17
rSBA-MenC (Post-Boost M1) Number Analyzed 195 participants 58 participants
193 50
rSBA-MenC (Post-Boost M12) Number Analyzed 166 participants 45 participants
88 11
rSBA-MenC (Post-Boost M24) Number Analyzed 187 participants 56 participants
78 6
rSBA-MenC (Post-Boost M48) Number Analyzed 194 participants 58 participants
58 5
12.Primary Outcome
Title rSBA-MenC Antibody Titers
Hide Description 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.
Time Frame At Year 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 195 58
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
rSBA-MenC (Pre-Primary) Number Analyzed 194 participants 53 participants
4.7
(4.2 to 5.2)
4.2
(3.9 to 4.6)
rSBA-MenC (Post-Primary) Number Analyzed 194 participants 55 participants
616.1
(521.3 to 728.2)
983.9
(742.6 to 1303.7)
rSBA-MenC (Pre-Boost) Number Analyzed 195 participants 55 participants
64.3
(50.3 to 82.4)
30.8
(18.8 to 50.4)
rSBA-MenC (Post-Boost M1) Number Analyzed 195 participants 58 participants
2537.0
(2071.9 to 3106.5)
507.0
(338.3 to 759.8)
rSBA-MenC (Post-Boost M12) Number Analyzed 166 participants 45 participants
124.1
(97.5 to 158.0)
30.6
(18.7 to 50.1)
rSBA-MenC (Post-Boost M24) Number Analyzed 187 participants 56 participants
47.9
(35.7 to 64.3)
12.1
(7.7 to 18.8)
rSBA-MenC (Post-Boost M48) Number Analyzed 194 participants 58 participants
30.4
(22.9 to 40.4)
11.3
(7.7 to 16.5)
13.Primary Outcome
Title 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)
Hide Description The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time Frame At Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 206 64
Measure Type: Number
Unit of Measure: Subjects
Anti-PRP ≥ 0.15 µg/mL (Pre-Primary) Number Analyzed 206 participants 63 participants
84 25
Anti-PRP ≥ 1.0 µg/mL (Pre-Primary) Number Analyzed 206 participants 63 participants
204 58
Anti-PRP ≥ 0.15 µg/mL (Post-Primary) Number Analyzed 204 participants 63 participants
199 45
Anti-PRP ≥ 1.0 µg/mL (Post-Primary) Number Analyzed 204 participants 63 participants
203 63
Anti-PRP ≥ 0.15 µg/mL (Pre-Boost) Number Analyzed 204 participants 64 participants
198 63
Anti-PRP ≥ 1.0 µg/mL (Pre-Boost) Number Analyzed 204 participants 64 participants
20 11
Anti-PRP ≥ 0.15 µg/mL (Post-Boost) Number Analyzed 203 participants 63 participants
198 43
Anti-PRP ≥ 1.0 µg/mL (Post-Boost) Number Analyzed 203 participants 63 participants
120 19
Anti-PRP ≥ 0.15 µg/mL PIV (M12) Number Analyzed 198 participants 63 participants
203 63
Anti-PRP ≥ 1.0 µg/mL PIV (M12) Number Analyzed 198 participants 63 participants
188 52
14.Primary Outcome
Title Concentration of Anti-PRP Antibodies
Hide Description 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.
Time Frame At Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 206 64
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Anti-PRP (Pre-Primary) Number Analyzed 206 participants 63 participants
0.160
(0.137 to 0.186)
0.178
(0.130 to 0.243)
Anti-PRP (Post-Primary) Number Analyzed 204 participants 63 participants
12.413
(10.688 to 14.417)
2.473
(1.557 to 3.928)
Anti-PRP (Pre-Boost) Number Analyzed 204 participants 64 participants
1.293
(1.095 to 1.528)
0.441
(0.309 to 0.627)
Anti-PRP (Post-Boost) Number Analyzed 203 participants 63 participants
88.667
(74.609 to 105.373)
39.024
(30.588 to 49.786)
Anti-PRP PIV (M12) Number Analyzed 198 participants 63 participants
7.153
(6.029 to 8.486)
3.162
(2.316 to 4.318)
15.Primary Outcome
Title Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Hide Description The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time Frame At Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 230 75
Measure Type: Number
Unit of Measure: Subjects
Anti-PRP ≥ 0.15 µg/mL (Pre-Primary) Number Analyzed 230 participants 73 participants
93 30
Anti-PRP ≥ 1.0 µg/mL (Pre-Primary) Number Analyzed 230 participants 73 participants
18 9
Anti-PRP ≥ 0.15 µg/mL (Post-Primary) Number Analyzed 227 participants 73 participants
227 66
Anti-PRP ≥ 1.0 µg/mL (Post-Primary) Number Analyzed 227 participants 73 participants
222 52
Anti-PRP ≥ 0.15 µg/mL (Pre-Boost) Number Analyzed 229 participants 74 participants
222 53
Anti-PRP ≥ 1.0 µg/mL (Pre-Boost) Number Analyzed 229 participants 74 participants
134 21
Anti-PRP ≥ 0.15 µg/mL (Post-Boost M1) Number Analyzed 228 participants 75 participants
228 75
Anti-PRP ≥ 1.0 µg/mL (Post-Boost M1) Number Analyzed 228 participants 75 participants
228 75
Anti-PRP ≥ 0.15 µg/mL (Post-Boost M12) Number Analyzed 182 participants 57 participants
182 57
Anti-PRP ≥ 1.0 µg/mL (Post-Boost M12) Number Analyzed 182 participants 57 participants
172 48
Anti-PRP ≥ 0.15 µg/mL (Post-Boost M24) Number Analyzed 228 participants 75 participants
227 74
Anti-PRP ≥ 1.0 µg/mL (Post-Boost M24) Number Analyzed 228 participants 75 participants
203 56
16.Primary Outcome
Title Number of Subjects With Anti-PRP Antibodies ≥0.15 µg/mL and ≥1 µg/mL for Meningitec+Hiberix Group
Hide Description The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time Frame At Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Meningitec+Hiberix Group
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 72
Measure Type: Number
Unit of Measure: Subjects
Anti-PRP ≥ 0.15 µg/mL (Aged 40-43 mths) 62
Anti-PRP ≥ 1.0 µg/mL (Aged 40-43 mths) 28
17.Primary Outcome
Title Concentration of Anti-PRP Antibodies
Hide Description 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.
Time Frame At Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 230 75
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Anti-PRP (Pre-Primary) Number Analyzed 230 participants 73 participants
0.153
(0.134 to 0.176)
0.163
(0.125 to 0.213)
Anti-PRP (Post-Primary) Number Analyzed 227 participants 73 participants
12.794
(11.159 to 14.669)
2.396
(1.580 to 3.635)
Anti-PRP (Pre-Boost) Number Analyzed 229 participants 74 participants
1.260
(1.080 to 1.469)
0.425
(0.310 to 0.582)
Anti-PRP (Post-Boost M1) Number Analyzed 228 participants 75 participants
91.981
(78.700 to 107.503)
44.002
(34.546 to 56.048)
Anti-PRP (Post-Boost M12) Number Analyzed 182 participants 57 participants
7.107
(5.931 to 8.516)
3.456
(2.488 to 4.799)
Anti-PRP (Post-Boost M24) Number Analyzed 228 participants 75 participants
4.790
(4.065 to 5.644)
2.339
(1.798 to 3.042)
18.Primary Outcome
Title Concentration of Anti-PRP Antibodies for Meningitec+Hiberix Group
Hide Description 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.
Time Frame At Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Meningitec+Hiberix Group
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 72
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
0.668
(0.467 to 0.956)
19.Primary Outcome
Title Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Hide Description The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time Frame At Year 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 197 58
Measure Type: Number
Unit of Measure: Subjects
Anti-PRP ≥ 0.15 µg/mL (Pre-Primary) Number Analyzed 197 participants 56 participants
77 24
Anti-PRP ≥ 1.0 µg/mL (Pre-Primary) Number Analyzed 197 participants 56 participants
14 9
Anti-PRP ≥ 0.15 µg/mL (Post-Primary) Number Analyzed 196 participants 55 participants
196 48
Anti-PRP ≥ 1.0 µg/mL (Post-Primary) Number Analyzed 196 participants 55 participants
191 33
Anti-PRP ≥ 0.15 µg/mL (Pre-Boost) Number Analyzed 197 participants 57 participants
191 38
Anti-PRP ≥ 1.0 µg/mL (Pre-Boost) Number Analyzed 197 participants 57 participants
119 14
Anti-PRP ≥ 0.15 µg/mL (Post-Boost M1) Number Analyzed 195 participants 57 participants
195 57
Anti-PRP ≥ 1.0 µg/mL (Post-Boost M1) Number Analyzed 195 participants 57 participants
195 57
Anti-PRP ≥ 0.15 µg/mL (Post-Boost M12) Number Analyzed 164 participants 48 participants
164 48
Anti-PRP ≥ 1.0 µg/mL (Post-Boost M12) Number Analyzed 164 participants 48 participants
157 40
Anti-PRP ≥ 0.15 µg/mL (Post-Boost M24) Number Analyzed 194 participants 56 participants
193 55
Anti-PRP ≥ 1.0 µg/mL (Post-Boost M24) Number Analyzed 194 participants 56 participants
174 40
Anti-PRP ≥ 0.15 µg/mL (Post-Boost M48) Number Analyzed 197 participants 58 participants
197 58
Anti-PRP ≥ 1.0 µg/mL (Post-Boost M48) Number Analyzed 197 participants 58 participants
171 36
20.Primary Outcome
Title Concentration of Anti-PRP Antibodies
Hide Description 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.
Time Frame At Year 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 197 58
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Anti-PRP (Pre-Primary) Number Analyzed 197 participants 56 participants
0.149
(0.129 to 0.173)
0.180
(0.130 to 0.250)
Anti-PRP (Post-Primary) Number Analyzed 196 participants 55 participants
12.715
(10.945 to 14.771)
1.776
(1.058 to 2.979)
Anti-PRP (Pre-Boost) Number Analyzed 197 participants 57 participants
1.276
(1.080 to 1.508)
0.380
(0.263 to 0.550)
Anti-PRP (Post-Boost M1) Number Analyzed 195 participants 57 participants
90.101
(76.087 to 106.697)
39.105
(29.506 to 51.825)
Anti-PRP (Post-Boost M12) Number Analyzed 164 participants 48 participants
7.455
(6.176 to 8.998)
3.557
(2.450 to 5.165)
Anti-PRP (Post-Boost M24) Number Analyzed 194 participants 56 participants
4.928
(4.135 to 5.873)
2.083
(1.524 to 2.847)
Anti-PRP (Post-Boost M48) Number Analyzed 197 participants 58 participants
3.824
(3.218 to 4.543)
1.673
(1.215 to 2.305)
21.Primary Outcome
Title 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)
Hide Description The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time Frame At Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 206 64
Measure Type: Number
Unit of Measure: Subjects
Anti-PSC ≥ 0.3 µg/mL (Pre-Primary) Number Analyzed 206 participants 63 participants
19 4
Anti-PSC ≥ 2 µg/mL (Pre-Primary) Number Analyzed 206 participants 63 participants
8 1
Anti-PSC ≥ 0.3 µg/mL (Post-Primary) Number Analyzed 202 participants 63 participants
202 63
Anti-PSC ≥ 2 µg/mL (Post-Primary) Number Analyzed 202 participants 63 participants
201 63
Anti-PSC ≥ 0.3 µg/mL (Pre-Booster) Number Analyzed 201 participants 64 participants
170 56
Anti-PSC ≥ 2 µg/mL (Pre-Booster) Number Analyzed 201 participants 64 participants
27 10
Anti-PSC ≥ 0.3 µg/mL (Post-Booster) Number Analyzed 205 participants 64 participants
205 64
Anti-PSC ≥ 2 µg/mL (Post-Booster) Number Analyzed 205 participants 64 participants
183 47
Anti-PSC ≥ 0.3 µg/mL (PIV [M12]) Number Analyzed 193 participants 59 participants
119 29
Anti-PSC ≥ 2 µg/mL (PIV [M12]) Number Analyzed 193 participants 59 participants
19 2
22.Primary Outcome
Title Concentration of Anti-PSC Antibodies
Hide Description 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.
Time Frame At Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 206 64
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Anti-PSC (Pre-Primary) Number Analyzed 206 participants 63 participants
0.18
(0.17 to 0.20)
0.17
(0.15 to 0.18)
Anti-PSC (Post-Primary) Number Analyzed 202 participants 63 participants
9.52
(8.68 to 10.45)
11.20
(9.42 to 13.33)
Anti-PSC (Pre-Booster) Number Analyzed 201 participants 64 participants
0.77
(0.67 to 0.88)
0.84
(0.66 to 1.06)
Anti-PSC (Post-Booster) Number Analyzed 205 participants 64 participants
7.36
(6.46 to 8.39)
3.51
(2.84 to 4.32)
Anti-PSC (PIV [M12]) Number Analyzed 193 participants 59 participants
0.47
(0.40 to 0.55)
0.32
(0.26 to 0.40)
23.Primary Outcome
Title Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Hide Description The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time Frame At Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 230 76
Measure Type: Number
Unit of Measure: Subjects
Anti-PSC ≥ 0.3 µg/mL (Pre-Primary) Number Analyzed 229 participants 73 participants
26 6
Anti-PSC ≥ 2 µg/mL (Pre-Primary) Number Analyzed 229 participants 73 participants
12 1
Anti-PSC ≥ 0.3 µg/mL (Post-Primary) Number Analyzed 225 participants 72 participants
225 72
Anti-PSC ≥ 2 µg/mL (Post-Primary) Number Analyzed 225 participants 72 participants
224 72
Anti-PSC ≥ 0.3 µg/mL (Pre-Booster) Number Analyzed 226 participants 74 participants
188 66
Anti-PSC ≥ 2 µg/mL (Pre-Booster) Number Analyzed 226 participants 74 participants
27 13
Anti-PSC ≥ 0.3 µg/mL (Post-Booster [M1] Number Analyzed 230 participants 76 participants
230 76
Anti-PSC ≥ 2 µg/mL (Post-Booster) [M1] Number Analyzed 230 participants 76 participants
210 59
Anti-PSC ≥ 0.3µg/mL (Post-Booster [M12] Number Analyzed 178 participants 54 participants
110 26
Anti-PSC ≥ 2 µg/mL (Post-Booster [M12]) Number Analyzed 178 participants 54 participants
16 2
Anti-PSC ≥0.3 µg/mL (Post-Booster [M24] Number Analyzed 226 participants 75 participants
76 17
Anti-PSC ≥ 2 µg/mL (Post-Booster [M24]) Number Analyzed 226 participants 75 participants
5 0
24.Primary Outcome
Title Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL for Meningitec+Hiberix Group
Hide Description The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time Frame At Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Meningitec+Hiberix Group
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 72
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-PSC ≥ 0.3 µg/mL (Aged 40-43 mths)
4
   5.6%
Anti-PSC ≥2 µg/mL (Aged 40-43 mths)
0
   0.0%
25.Primary Outcome
Title Concentration of Anti-PSC Antibodies
Hide Description 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.
Time Frame At Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 230 76
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Anti-PSC (Pre-Primary) Number Analyzed 229 participants 73 participants
0.20
(0.18 to 0.22)
0.17
(0.15 to 0.18)
Anti-PSC (Post-Primary) Number Analyzed 225 participants 72 participants
9.35
(8.56 to 10.22)
12.29
(10.50 to 14.39)
Anti-PSC (Pre-Booster) Number Analyzed 226 participants 74 participants
0.74
(0.65 to 0.84)
0.87
(0.69 to 1.10)
Anti-PSC (Post-Booster [M1]) Number Analyzed 230 participants 76 participants
7.41
(6.59 to 8.33)
3.91
(3.19 to 4.79)
Anti-PSC (Post-Booster [M12]) Number Analyzed 178 participants 54 participants
0.47
(0.40 to 0.55)
0.32
(0.25 to 0.40)
Anti-PSC (Post-Booster [M24]) Number Analyzed 226 participants 75 participants
0.25
(0.23 to 0.28)
0.21
(0.18 to 0.24)
26.Primary Outcome
Title Concentration of Anti-PSC Antibodies for Meningitec+Hiberix Group
Hide Description 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.
Time Frame At Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Meningitec+Hiberix Group
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 72
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
0.16
(0.15 to 0.18)
27.Primary Outcome
Title Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Hide Description The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time Frame At Year 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 197 58
Measure Type: Number
Unit of Measure: Subjects
Anti-PSC ≥ 0.3 µg/mL (Pre-Primary) Number Analyzed 197 participants 56 participants
19 3
Anti-PSC ≥ 2 µg/mL (Pre-Primary) Number Analyzed 197 participants 56 participants
7 1
Anti-PSC ≥ 0.3 µg/mL (Post-Primary) Number Analyzed 197 participants 54 participants
194 54
Anti-PSC ≥ 2 µg/mL (Post-Primary) Number Analyzed 197 participants 54 participants
193 54
Anti-PSC ≥ 0.3 µg/mL (Pre-Boost) Number Analyzed 197 participants 57 participants
163 52
Anti-PSC ≥ 2 µg/mL (Pre-Boost) Number Analyzed 194 participants 57 participants
24 9
Anti-PSC ≥ 0.3 µg/mL (Post-Boost [M1]) Number Analyzed 197 participants 58 participants
197 58
Anti-PSC ≥ 2 µg/mL (Post-Boost [M1]) Number Analyzed 197 participants 58 participants
179 43
Anti-PSC ≥ 0.3 µg/mL (Post-Boost [M12]) Number Analyzed 161 participants 45 participants
101 22
Anti-PSC ≥ 2 µg/mL (Post-Boost [M12]) Number Analyzed 161 participants 45 participants
15 2
Anti-PSC ≥ 0.3 µg/mL (Post-Boost [M24]) Number Analyzed 193 participants 56 participants
69 10
Anti-PSC ≥ 2 µg/mL (Post-Boost [M24]) Number Analyzed 193 participants 56 participants
5 0
Anti-PSC ≥ 0.3 µg/mL (Post-Boost [M48]) Number Analyzed 192 participants 56 participants
38 4
Anti-PSC ≥ 2 µg/mL (Post-Boost [M48]) Number Analyzed 192 participants 56 participants
6 0
28.Primary Outcome
Title Concentration of Anti-PSC Antibodies
Hide Description 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.
Time Frame At Year 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 197 58
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Anti-PSC (Pre-Primary) Number Analyzed 197 participants 56 participants
0.19
(0.17 to 0.21)
0.16
(0.15 to 0.18)
Anti-PSC (Post-Primary) Number Analyzed 194 participants 54 participants
9.41
(8.55 to 10.36)
11.88
(9.75 to 14.46)
Anti-PSC (Pre-Boost) Number Analyzed 194 participants 57 participants
0.76
(0.66 to 0.87)
0.85
(0.66 to 1.09)
Anti-PSC (Post-Boost [M1]) Number Analyzed 197 participants 58 participants
7.46
(6.55 to 8.49)
3.76
(2.94 to 4.80)
Anti-PSC (Post-Boost [M12]) Number Analyzed 161 participants 45 participants
0.48
(0.41 to 0.57)
0.34
(0.26 to 0.45)
Anti-PSC (Post-Boost [M24]) Number Analyzed 193 participants 56 participants
0.27
(0.23 to 0.30)
0.19
(0.16 to 0.22)
Anti-PSC (Post-Boost [M48]) Number Analyzed 192 participants 56 participants
0.21
(0.19 to 0.23)
0.17
(0.15 to 0.19)
29.Primary Outcome
Title 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)
Hide Description The anti-pertussis toxoid, anti-filamentous haemagglutin, anti-pertactin activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time Frame At Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 67 23
Measure Type: Number
Unit of Measure: Subjects
Anti-PT Pre-Primary Number Analyzed 64 participants 18 participants
11 3
Anti-PT Post-Primary (M3) Number Analyzed 63 participants 20 participants
63 20
Anti-PT Post-Primary (M10) Number Analyzed 66 participants 21 participants
34 10
Anti-PT Pre-Boost Number Analyzed 67 participants 23 participants
8 3
Anti-FHA Pre-Primary Number Analyzed 65 participants 19 participants
40 12
Anti-FHA Post-Primary (M3) Number Analyzed 63 participants 20 participants
63 20
Anti-FHA Post-Primary (M10) Number Analyzed 65 participants 21 participants
65 21
Anti-FHA Pre-Boost Number Analyzed 64 participants 22 participants
47 13
Anti-PRN Pre-Primary Number Analyzed 64 participants 19 participants
22 4
Anti-PRN Post-Primary (M3) Number Analyzed 63 participants 20 participants
63 20
Anti-PRN Post-Primary (M10) Number Analyzed 66 participants 21 participants
53 14
Anti-PRN Pre-Boost Number Analyzed 67 participants 23 participants
34 7
30.Primary Outcome
Title Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Hide Description 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.
Time Frame At Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 67 23
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-PT Pre-Primary Number Analyzed 64 participants 18 participants
3.2
(2.8 to 3.7)
3.3
(2.4 to 4.6)
Anti-PT Post-Primary (M3) Number Analyzed 63 participants 20 participants
44.8
(39.1 to 51.2)
40.1
(31.7 to 50.8)
Anti-PT Post-Primary (M10) Number Analyzed 66 participants 21 participants
4.9
(4.1 to 5.9)
4.5
(3.3 to 6.1)
Anti-PT Pre-Boost Number Analyzed 67 participants 23 participants
2.9
(2.6 to 3.2)
3.0
(2.4 to 3.6)
Anti-FHA Pre-Primary Number Analyzed 65 participants 19 participants
6.5
(5.2 to 8.2)
7.8
(4.7 to 13.0)
Anti-FHA Post-Primary (M3) Number Analyzed 63 participants 20 participants
223.5
(194.6 to 256.7)
160.2
(123.1 to 208.6)
Anti-FHA Post-Primary (M10) Number Analyzed 65 participants 21 participants
30.4
(25.7 to 35.9)
25.8
(19.0 to 34.9)
Anti-FHA Pre-Boost Number Analyzed 64 participants 22 participants
15.1
(9.5 to 24.0)
20.3
(8.0 to 51.8)
Anti-PRN Pre-Primary Number Analyzed 64 participants 19 participants
4.2
(3.4 to 5.2)
3.1
(2.5 to 3.9)
Anti-PRN Post-Primary (M3) Number Analyzed 63 participants 20 participants
116.3
(93.7 to 144.5)
46.1
(31.0 to 68.5)
Anti-PRN Post-Primary (M10) Number Analyzed 66 participants 21 participants
12.5
(9.5 to 16.2)
6.6
(4.4 to 9.9)
Anti-PRN Pre-Boost Number Analyzed 67 participants 23 participants
5.9
(4.5 to 7.7)
4.3
(2.8 to 6.5)
31.Primary Outcome
Title Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL
Hide Description The anti-pertussis toxoid, anti-filamentous haemagglutin, anti-pertactin activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time Frame At Year 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 44 14
Measure Type: Number
Unit of Measure: Subjects
Anti-PT Pre-Primary Number Analyzed 41 participants 12 participants
9 2
Anti-PT Post-Primary (M3) Number Analyzed 42 participants 11 participants
42 11
Anti-PT Post-Primary (M10) Number Analyzed 44 participants 13 participants
24 5
Anti-PT Pre-Boost ( M32) Number Analyzed 43 participants 14 participants
6 2
Anti-PT Post-Boost ( M24) Number Analyzed 44 participants 13 participants
30 9
Anti-FHA Pre-Primary Number Analyzed 42 participants 12 participants
27 9
Anti-FHA Post-Primary (M3) Number Analyzed 42 participants 11 participants
42 11
Anti-FHA Post-Primary (M10) Number Analyzed 44 participants 13 participants
43 13
Anti-FHA Pre-Boost ( M32) Number Analyzed 41 participants 13 participants
29 10
Anti-FHA Post-Boost ( M24) Number Analyzed 41 participants 14 participants
41 14
Anti-PRN Pre-Primary Number Analyzed 41 participants 12 participants
13 3
Anti-PRN Post-Primary (M3) Number Analyzed 42 participants 11 participants
42 11
Anti-PRN Post-Primary (M10) Number Analyzed 44 participants 13 participants
36 8
Anti-PRN Pre-Boost ( M32) Number Analyzed 43 participants 14 participants
25 4
Anti-PRN Post-Boost ( M24) Number Analyzed 44 participants 14 participants
43 14
32.Primary Outcome
Title Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
Hide Description 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.
Time Frame At Year 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 44 14
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-PT Pre-Primary Number Analyzed 41 participants 12 participants
3.4
(2.8 to 4.1)
3.4
(2.1 to 5.5)
Anti-PT Post-Primary (M3) Number Analyzed 42 participants 11 participants
45.2
(37.2 to 54.8)
36.5
(26.1 to 51.1)
Anti-PT Post-Primary (M10) Number Analyzed 44 participants 13 participants
5.1
(4.1 to 6.4)
3.9
(2.7 to 5.6)
Anti-PT Pre-Boost ( M32) Number Analyzed 43 participants 14 participants
3.0
(2.5 to 3.5)
3.1
(2.3 to 4.1)
Anti-PT Post-Boost ( M24) Number Analyzed 44 participants 13 participants
8.2
(6.1 to 10.9)
7.2
(3.9 to 13.4)
Anti-FHA Pre-Primary Number Analyzed 42 participants 12 participants
7.2
(5.2 to 10.0)
9.1
(4.7 to 17.6)
Anti-FHA Post-Primary (M3) Number Analyzed 42 participants 11 participants
229.9
(188.5 to 280.4)
169.8
(127.0 to 227.0)
Anti-FHA Post-Primary (M10) Number Analyzed 44 participants 13 participants
27.2
(22.1 to 33.5)
22.8
(15.6 to 33.3)
Anti-FHA Pre-Boost ( M32) Number Analyzed 41 participants 13 participants
16.7
(9.0 to 30.9)
33.1
(9.6 to 113.8)
Anti-FHA Post-Boost ( M24) Number Analyzed 41 participants 14 participants
164.7
(119.4 to 227.1)
66.8
(43.8 to 101.7)
Anti-PRN Pre-Primary Number Analyzed 41 participants 12 participants
3.9
(3.1 to 4.9)
3.1
(2.4 to 4.1)
Anti-PRN Post-Primary (M3) Number Analyzed 42 participants 11 participants
135.6
(106.0 to 173.4)
50.4
(26.0 to 97.6)
Anti-PRN Post-Primary (M10) Number Analyzed 44 participants 13 participants
12.2
(8.9 to 16.7)
5.6
(3.6 to 8.8)
Anti-PRN Pre-Boost ( M32) Number Analyzed 43 participants 14 participants
6.6
(4.5 to 9.5)
4.9
(2.4 to 9.8)
Anti-PRN Post-Boost ( M24) Number Analyzed 44 participants 14 participants
102.8
(67.1 to 157.3)
23.4
(15.1 to 36.2)
33.Primary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame Up to Month 12 (Booster vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study NCT00258700.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 359 117
Measure Type: Number
Unit of Measure: Subjects
0 0
34.Primary Outcome
Title Number of Subjects With SAE(s)
Hide Description 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.
Time Frame Up to Month 24 (Booster vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study NCT00258700.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 359 117
Measure Type: Number
Unit of Measure: Subjects
0 0
35.Primary Outcome
Title Number of Subjects With SAE(s)
Hide Description 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.
Time Frame Up to Month 48 (Booster vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
The Booster Total Vaccinated Cohort included all subjects who received the booster dose during study NCT00258700.
Arm/Group Title Menitorix Group Meningitec Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 359 117
Measure Type: Number
Unit of Measure: Subjects
1 0
36.Primary Outcome
Title Number of Subjects With SAE(s)
Hide Description 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.
Time Frame Within (31-Days) at Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Menitorix Group Meningitec Group Meningitec+Hiberix Group
Hide Arm/Group Description:
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.
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.

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.

Overall Number of Participants Analyzed 70 23 72
Measure Type: Number
Unit of Measure: Subjects
1 0 0
Time Frame SAEs: from booster study NCT00258700 until the end of the persistence study (M48).
Adverse Event Reporting Description 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.
 
Arm/Group Title Menitorix Group Meningitec Group Meningitec+Hiberix Group
Hide Arm/Group Description 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. 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.

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.

All-Cause Mortality
Menitorix Group Meningitec Group Meningitec+Hiberix Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/359 (0.00%)   0/117 (0.00%)   0/74 (0.00%) 
Hide Serious Adverse Events
Menitorix Group Meningitec Group Meningitec+Hiberix Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/359 (0.56%)   0/117 (0.00%)   0/74 (0.00%) 
General disorders       
Pyrexia *  1/359 (0.28%)  0/117 (0.00%)  /74 
Respiratory, thoracic and mediastinal disorders       
Asthma *  1/70 (1.43%)  0/23 (0.00%)  /74 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Menitorix Group Meningitec Group Meningitec+Hiberix Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications:
Khatami A et al. Antibody concentrations against pertussis antigens at age 5 years following infant and pre-school immunisation: follow-on of a randomized controlled trial. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID). Melbourne, Australia, 16-19 November 2011.
Khatami A et al. Persistence of antibody response following a booster dose of Hib-MenC-TT glycoconjugate vaccine: A phase IV open randomized controlled trial. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
Snape MD et al. Persistence of antibody response following a booster dose of Hib-MenC-TT glycoconjugate vaccine to five years: a follow-on study. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID). Melbourne, Australia, 16-19 November 2011.
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00454987    
Other Study ID Numbers: 109664
109666 ( Other Identifier: GSK )
109668 ( Other Identifier: GSK )
2006-006460-32 ( EudraCT Number )
First Submitted: March 30, 2007
First Posted: April 2, 2007
Results First Submitted: November 12, 2015
Results First Posted: December 16, 2015
Last Update Posted: June 16, 2020