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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00454987
• Collaborator: (none)
• Enrollment: 288
• Locations: 9
• Arms: 3
• Actual Duration (Months): 4.9
• Patients Per Site: 32
• Patients Per Site Per Month: 6.5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the long-term antibody persistence at 12, 24 and 48 months after the administration of a booster dose of Menitorix™, given at 12-15 months of age. The children had previously received 3 doses of Menitorix™ and Infanrix IPV™ or Meningitec™ and Pediacel™ in infancy. In addition, the antibody persistence is to be investigated in children of 40-43 months of age who received a 3-dose primary vaccination of a MenC conjugate vaccine and a Hib containing vaccine in infancy without a booster dose of MenC conjugate and Hib vaccine in the second year of life.

This protocol posting deals with objectives & outcome measures of the extension phases at 12, 24 and 48 months after the booster phase. The links to objectives and outcome measures of the primary phase & booster phase at 12 to 15 months are provided below:

https://www.gsk-studyregister.com/study/2747 (Primary phase) https://www.gsk-studyregister.com/study/2755 (Booster phase)

Condition or Disease	Intervention/Treatment	Phase
Haemophilus Influenzae Type b; Neisseria Meningitidis; Neisseria Meningitidis-Haemophilus Influenzae Type b Vaccine	Biological: Menitorix; Biological: Infanrix IPV	Phase 4

Detailed Description

This multicentre & multicountry study is open and has 2 study groups at Visits 1 and 3 (HibMenC and LicMenC). An additional control group in the UK at the time of the second year follow-up for persistence (subjects aged 40-43 months primed with MenC conjugate and Hib vaccines in infancy with no subsequent booster dose, group NoBoost at Visit 2). These subjects will receive a Hib catch-up vaccine at 40-43 months of age. The subjects of groups HibMenC and LicMenC were randomized in the primary vaccination study 103974 and will not be further randomized. The subjects of group NoBoost will not be randomized. All subjects at the UK centre will receive Infanrix™-IPV at the second visit (i.e. 24 months after Menitorix booster or at 40-43 months of age). In addition, the subjects of group NoBoost will receive a Hib catch-up vaccine (Menitorix™) at the same visit.

Subjects of groups HibMenC and LicMenC will have 3 blood samples taken for immunogenicity analyses: at 12, 24 & 48 months after the booster vaccination. Subjects of group NoBoost will have 1 blood sample taken for immunogenicity analyses at 40-43 months of age. 75 new subjects will be enrolled in this study (group NoBoost).

Study Design

• Study Type: Interventional
• Actual Enrollment: 288 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Assessment of Long-term Antibody Persistence After a Booster Dose of GSK Biologicals' Hib & Meningococcal C Vaccine (Menitorix™) 811936 Given at 12-15 Months of Age to Subjects Primed With 3 Doses of Menitorix™ at 2, 3, 4 Months of Age
• Actual Study Start Date: May 16, 2007
• Actual Primary Completion Date: Oct 12, 2007
• Actual Study Completion Date: Oct 12, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: Infanrix IPV; Infanrix IPV was administered according to the manufacturer's instructions to UK subjects at 40 to 43 months of age.
Active Comparator: 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.	Biological: Infanrix IPV; Infanrix IPV was administered according to the manufacturer's instructions to UK subjects at 40 to 43 months of age.
Active Comparator: 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.	Biological: Menitorix; Menitorix was only administered to subjects of the group Meningitic+Hiberix group at 40 to 43 months of age.; Biological: Infanrix IPV; Infanrix IPV was administered according to the manufacturer's instructions to UK subjects at 40 to 43 months of age.

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above 1:8 [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.

2. Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 [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.

3. rSBA-MenC Antibody Titers [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.

4. Number of Subjects With rSBA-MenC Antibody Titers ≥1:8 [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.

5. Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 for Meningitec+Hiberix Group [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.

6. Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 [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.

7. Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 for Meningitec+Hiberix Group [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.

8. rSBA-MenC Antibody Titers [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.

9. rSBA-MenC Antibody Titers for Meningitec+Hiberix Group [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.

10. Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 [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.

11. Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 [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.

12. rSBA-MenC Antibody Titers [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.

13. 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) [At Year 1]

    The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).

14. Concentration of Anti-PRP Antibodies [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.

15. Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL [At Year 2]

    The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).

16. Number of Subjects With Anti-PRP Antibodies ≥0.15 µg/mL and ≥1 µg/mL for Meningitec+Hiberix Group [At Year 2]

    The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).

17. Concentration of Anti-PRP Antibodies [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.

18. Concentration of Anti-PRP Antibodies for Meningitec+Hiberix Group [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.

19. Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL [At Year 4]

    The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).

20. Concentration of Anti-PRP Antibodies [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.

21. 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) [At Year 1]

    The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).

22. Concentration of Anti-PSC Antibodies [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.

23. Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL [At Year 2]

    The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).

24. Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL for Meningitec+Hiberix Group [At Year 2]

    The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).

25. Concentration of Anti-PSC Antibodies [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.

26. Concentration of Anti-PSC Antibodies for Meningitec+Hiberix Group [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.

27. Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL [At Year 4]

    The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).

28. Concentration of Anti-PSC Antibodies [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.

29. 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) [At Year 2]

    The anti-pertussis toxoid, anti-filamentous haemagglutin, anti-pertactin activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).

30. Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies [At Year 2]

    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.

31. Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL [At Year 4]

    The anti-pertussis toxoid, anti-filamentous haemagglutin, anti-pertactin activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).

32. Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies [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.

33. Number of Subjects With Serious Adverse Events (SAEs) [Up to Month 12 (Booster vaccination)]

    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.

34. Number of Subjects With SAE(s) [Up to Month 24 (Booster vaccination)]

    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.

35. Number of Subjects With SAE(s) [Up to Month 48 (Booster vaccination)]

    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.

36. Number of Subjects With SAE(s) [Within (31-Days) at Year 2]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 24 Months to 64 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Subjects of groups HibMenC and LicMenC at Visits 1, 2 and 3:

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.

• A male or female between and including 24 and 31 months of age at the time of Visit 1, between and including 40 and 43 months of age at Visit 2 and between and including 60 and 64 months at Visit 3.

• Written informed consent obtained from the parent or guardian of the subject.

• Healthy subjects as established by medical history and clinical examination before entering into the study.

• Having completed the booster vaccination study 104056.

Subjects of group NoBoost at Visit 2 (UK only):

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.

• A male or female between and including 40 and 43 months of age at Visit 2.

• Written informed consent obtained from the parent or guardian of the subject.

• Healthy subjects as established by medical history and clinical examination before entering into the study.

• Having received a 3-dose primary vaccination with a MenC conjugate vaccine and a Hib containing vaccine before the age of 8 months.

Exclusion Criteria:

• Previous administration of booster dose of Hib or meningococcal serogroup C except booster study vaccines during the study 104056.

• History of H. influenzae type b or meningococcal diseases.

• For UK subjects of groups HibMenC and LicMenC only: previous administration of a booster dose of a pertussis-containing vaccine except booster study vaccines during the study 104056.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Bydgoszcz		Poland	85-021
2	GSK Investigational Site	Gdansk		Poland	80-394
3	GSK Investigational Site	Kielce		Poland	25-711
4	GSK Investigational Site	Krakow		Poland	31-202
5	GSK Investigational Site	Leczna		Poland	21-010
6	GSK Investigational Site	Poznan		Poland	61-709
7	GSK Investigational Site	Siemianowice Slaskie		Poland	41-103
8	GSK Investigational Site	Trzebnica		Poland	55-100
9	GSK Investigational Site	Oxford	Oxfordshire	United Kingdom	OX3 7LJ

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

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.
• Khatami A, Snape MD, John T, Westcar S, Klinger C, Rollinson L, Boutriau D, Mesaros N, Wysocki J, Galaj A, Yu LM, Pollard AJ. Persistence of immunity following a booster dose of Haemophilus influenzae type B-Meningococcal serogroup C glycoconjugate vaccine: follow-up of a randomized controlled trial. Pediatr Infect Dis J. 2011 Mar;30(3):197-202. doi: 10.1097/INF.0b013e3181f728fd.
• Khatami A, Snape MD, Wysocki J, John TM, Westcar S, Mesaros N, Peddiraju K, Boutriau D, Yu LM, Pollard AJ. Persistence of antibody response following a booster dose of Hib-MenC-TT glycoconjugate vaccine to five years: a follow-up study. Pediatr Infect Dis J. 2012 Oct;31(10):1069-73. doi: 10.1097/INF.0b013e318262528c.
• 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.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00454987
• Other Study ID Numbers: 109664; 109666; 109668; 2006-006460-32
• First Posted: Apr 2, 2007
• Last Update Posted: Jun 16, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: antibody persistence; Meningococcal serogroup C vaccine; conjugate vaccine; Haemophilus influenzae type b vaccine
• Additional relevant MeSH terms: Influenza, Human; Haemophilus Infections

Study Results

Participant Flow

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 Detail	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
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
Period Title: Booster Period (NCT00258700)
STARTED	221	67	0
COMPLETED	221	67	0
NOT COMPLETED	0	0	0
Period Title: Booster Period (NCT00258700)
STARTED	235	77	74
COMPLETED	235	77	74
NOT COMPLETED	0	0	0
Period Title: Booster Period (NCT00258700)
STARTED	206	62	0
COMPLETED	206	62	0
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Menitorix Group	Meningitec Group	Meningitec+Hiberix Group	Total
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 Participants	359	117	74	550
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	27.9 (0.97)	27.7 (0.68)	27.85 (0.91)
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	40.6 (0.76)	40.6 (0.74)	40.5 (0.71)	40.5 (0.73)
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	61.1 (1.03)	61.0 (1.25)	61.0 (1.14)
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	12.8 (0.75)	12.8 (0.78)	12.8 (0.76)
Sex: Female, Male (Count of Participants)
Female	114 31.8%	33 28.2%	147 198.6%
Male	107 29.8%	34 29.1%	141 190.5%
Sex: Female, Male (Count of Participants)
Female	117 32.6%	37 31.6%	28 37.8%	182 33.1%
Male	118 32.9%	40 34.2%	46 62.2%	204 37.1%
Sex: Female, Male (Count of Participants)
Female	102 28.4%	31 26.5%	133 179.7%
Male	104 29%	31 26.5%	135 182.4%
Sex: Female, Male (Count of Participants)
Female	179 49.9%	62 53%	241 325.7%
Male	180 50.1%	55 47%	235 317.6%

Outcome Measures

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
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

Outcome Measure Data

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
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.
Measure Participants	204	64
rSBA-MenC (Pre-Primary)	12	3
rSBA-MenC (Post-Primary)	200	63
rSBA-MenC (Pre-Booster)	163	39
rSBA-MenC (Post-Booster)	201	61
rSBA-MenC PIV (M12)	178	41

2. Primary Outcome

Title	Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
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

Outcome Measure Data

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
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.
Measure Participants	204	64
rSBA-MenC (Pre-Primary)	3	0
rSBA-MenC (Post-Primary)	189	63
rSBA-MenC (Pre-Booster)	94	19
rSBA-MenC (Post-Booster)	199	56
rSBA-MenC PIV (M12)	109	17

3. Primary Outcome

Title	rSBA-MenC Antibody Titers
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

Outcome Measure Data

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
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.
Measure Participants	204	64
rSBA-MenC (Pre-Primary)	4.8	4.3
rSBA-MenC (Post-Primary)	624.7	1000.0
rSBA-MenC (Pre-Booster)	67.1	32.4
rSBA-MenC (Post-Booster)	2540.3	517.4
rSBA-MenC PIV (M12)	123.0	35.7

4. Primary Outcome

Title	Number of Subjects With rSBA-MenC Antibody Titers ≥1:8
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

Outcome Measure Data

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
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.
Measure Participants	228	76
rSBA-MenC (Pre-Primary)	16	2
rSBA-MenC (Post-Primary)	222	73
rSBA-MenC (Pre-Booster)	175	48
rSBA-MenC (Post-Booster M1)	227	73
rSBA-MenC (Post-Booster M12)	164	37
rSBA-MenC (Post-Booster M24)	147	30

5. Primary Outcome

Title	Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8 for Meningitec+Hiberix Group
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

Outcome Measure Data

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
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.
Measure Participants	68
Number [Subjects]	30

6. Primary Outcome

Title	Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
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

Outcome Measure Data

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
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.
Measure Participants	228	76
rSBA-MenC (Pre-Primary)	5	0
rSBA-MenC (Post-Primary)	208	73
rSBA-MenC (Pre-Booster)	96	22
rSBA-MenC (Post-Booster M1)	225	66
rSBA-MenC (Post-Booster M12)	98	15
rSBA-MenC (Post-Booster M24)	86	10

7. Primary Outcome

Title	Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128 for Meningitec+Hiberix Group
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

Outcome Measure Data

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
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.
Measure Participants	68
Number [Subjects]	11

8. Primary Outcome

Title	rSBA-MenC Antibody Titers
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

Outcome Measure Data

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
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.
Measure Participants	228	76
rSBA-MenC (Pre-Primary)	5.0	4.2
rSBA-MenC (Post-Primary)	592.3	1075.6
rSBA-MenC (Pre-Booster)	58.6	35.0
rSBA-MenC (Post-Booster M1)	2320.8	520.9
rSBA-MenC (Post-Booster M12)	122.3	35.9
rSBA-MenC (Post-Booster M24)	48.0	14.4

9. Primary Outcome

Title	rSBA-MenC Antibody Titers for Meningitec+Hiberix Group
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

Outcome Measure Data

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
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.
Measure Participants	68
Geometric Mean (95% Confidence Interval) [Titer]	15.9

10. Primary Outcome

Title	Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:8
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

Outcome Measure Data

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
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.
Measure Participants	195	58
rSBA-MenC (Pre-Primary)	10	2
rSBA-MenC (Post-Primary)	192	55
rSBA-MenC (Pre-Boost)	156	34
rSBA-MenC (Post-Boost M1)	194	56
rSBA-MenC (Post-Boost M12)	148	30
rSBA-MenC (Post-Boost M24)	123	20
rSBA-MenC (Post-Boost M48)	115	26

11. Primary Outcome

Title	Number of Subjects With rSBA-MenC Antibody Titers ≥ 1:128
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

Outcome Measure Data

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
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.
Measure Participants	195	58
rSBA-MenC (Pre-Primary)	2	0
rSBA-MenC (Post-Primary)	182	55
rSBA-MenC (Pre-Boost)	87	17
rSBA-MenC (Post-Boost M1)	193	50
rSBA-MenC (Post-Boost M12)	88	11
rSBA-MenC (Post-Boost M24)	78	6
rSBA-MenC (Post-Boost M48)	58	5

12. Primary Outcome

Title	rSBA-MenC Antibody Titers
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

Outcome Measure Data

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
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.
Measure Participants	195	58
rSBA-MenC (Pre-Primary)	4.7	4.2
rSBA-MenC (Post-Primary)	616.1	983.9
rSBA-MenC (Pre-Boost)	64.3	30.8
rSBA-MenC (Post-Boost M1)	2537.0	507.0
rSBA-MenC (Post-Boost M12)	124.1	30.6
rSBA-MenC (Post-Boost M24)	47.9	12.1
rSBA-MenC (Post-Boost M48)	30.4	11.3

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)
Description	The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time Frame	At Year 1

Outcome Measure Data

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
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.
Measure Participants	206	64
Anti-PRP ≥ 0.15 µg/mL (Pre-Primary)	84	25
Anti-PRP ≥ 1.0 µg/mL (Pre-Primary)	204	58
Anti-PRP ≥ 0.15 µg/mL (Post-Primary)	199	45
Anti-PRP ≥ 1.0 µg/mL (Post-Primary)	203	63
Anti-PRP ≥ 0.15 µg/mL (Pre-Boost)	198	63
Anti-PRP ≥ 1.0 µg/mL (Pre-Boost)	20	11
Anti-PRP ≥ 0.15 µg/mL (Post-Boost)	198	43
Anti-PRP ≥ 1.0 µg/mL (Post-Boost)	120	19
Anti-PRP ≥ 0.15 µg/mL PIV (M12)	203	63
Anti-PRP ≥ 1.0 µg/mL PIV (M12)	188	52

14. Primary Outcome

Title	Concentration of Anti-PRP Antibodies
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

Outcome Measure Data

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
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.
Measure Participants	206	64
Anti-PRP (Pre-Primary)	0.160	0.178
Anti-PRP (Post-Primary)	12.413	2.473
Anti-PRP (Pre-Boost)	1.293	0.441
Anti-PRP (Post-Boost)	88.667	39.024
Anti-PRP PIV (M12)	7.153	3.162

15. Primary Outcome

Title	Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Description	The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time Frame	At Year 2

Outcome Measure Data

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
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.
Measure Participants	230	75
Anti-PRP ≥ 0.15 µg/mL (Pre-Primary)	93	30
Anti-PRP ≥ 1.0 µg/mL (Pre-Primary)	18	9
Anti-PRP ≥ 0.15 µg/mL (Post-Primary)	227	66
Anti-PRP ≥ 1.0 µg/mL (Post-Primary)	222	52
Anti-PRP ≥ 0.15 µg/mL (Pre-Boost)	222	53
Anti-PRP ≥ 1.0 µg/mL (Pre-Boost)	134	21
Anti-PRP ≥ 0.15 µg/mL (Post-Boost M1)	228	75
Anti-PRP ≥ 1.0 µg/mL (Post-Boost M1)	228	75
Anti-PRP ≥ 0.15 µg/mL (Post-Boost M12)	182	57
Anti-PRP ≥ 1.0 µg/mL (Post-Boost M12)	172	48
Anti-PRP ≥ 0.15 µg/mL (Post-Boost M24)	227	74
Anti-PRP ≥ 1.0 µg/mL (Post-Boost M24)	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
Description	The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time Frame	At Year 2

Outcome Measure Data

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
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.
Measure Participants	72
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
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

Outcome Measure Data

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
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.
Measure Participants	230	75
Anti-PRP (Pre-Primary)	0.153	0.163
Anti-PRP (Post-Primary)	12.794	2.396
Anti-PRP (Pre-Boost)	1.260	0.425
Anti-PRP (Post-Boost M1)	91.981	44.002
Anti-PRP (Post-Boost M12)	7.107	3.456
Anti-PRP (Post-Boost M24)	4.790	2.339

18. Primary Outcome

Title	Concentration of Anti-PRP Antibodies for Meningitec+Hiberix Group
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

Outcome Measure Data

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
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.
Measure Participants	72
Geometric Mean (95% Confidence Interval) [µg/mL]	0.668

19. Primary Outcome

Title	Number of Subjects With Anti-PRP Antibodies ≥ 0.15 µg/mL and ≥ 1 µg/mL
Description	The anti-polyribosylribitol phosphate was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time Frame	At Year 4

Outcome Measure Data

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
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.
Measure Participants	197	58
Anti-PRP ≥ 0.15 µg/mL (Pre-Primary)	77	24
Anti-PRP ≥ 1.0 µg/mL (Pre-Primary)	14	9
Anti-PRP ≥ 0.15 µg/mL (Post-Primary)	196	48
Anti-PRP ≥ 1.0 µg/mL (Post-Primary)	191	33
Anti-PRP ≥ 0.15 µg/mL (Pre-Boost)	191	38
Anti-PRP ≥ 1.0 µg/mL (Pre-Boost)	119	14
Anti-PRP ≥ 0.15 µg/mL (Post-Boost M1)	195	57
Anti-PRP ≥ 1.0 µg/mL (Post-Boost M1)	195	57
Anti-PRP ≥ 0.15 µg/mL (Post-Boost M12)	164	48
Anti-PRP ≥ 1.0 µg/mL (Post-Boost M12)	157	40
Anti-PRP ≥ 0.15 µg/mL (Post-Boost M24)	193	55
Anti-PRP ≥ 1.0 µg/mL (Post-Boost M24)	174	40
Anti-PRP ≥ 0.15 µg/mL (Post-Boost M48)	197	58
Anti-PRP ≥ 1.0 µg/mL (Post-Boost M48)	171	36

20. Primary Outcome

Title	Concentration of Anti-PRP Antibodies
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

Outcome Measure Data

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
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.
Measure Participants	197	58
Anti-PRP (Pre-Primary)	0.149	0.180
Anti-PRP (Post-Primary)	12.715	1.776
Anti-PRP (Pre-Boost)	1.276	0.380
Anti-PRP (Post-Boost M1)	90.101	39.105
Anti-PRP (Post-Boost M12)	7.455	3.557
Anti-PRP (Post-Boost M24)	4.928	2.083
Anti-PRP (Post-Boost M48)	3.824	1.673

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)
Description	The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time Frame	At Year 1

Outcome Measure Data

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
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.
Measure Participants	206	64
Anti-PSC ≥ 0.3 µg/mL (Pre-Primary)	19	4
Anti-PSC ≥ 2 µg/mL (Pre-Primary)	8	1
Anti-PSC ≥ 0.3 µg/mL (Post-Primary)	202	63
Anti-PSC ≥ 2 µg/mL (Post-Primary)	201	63
Anti-PSC ≥ 0.3 µg/mL (Pre-Booster)	170	56
Anti-PSC ≥ 2 µg/mL (Pre-Booster)	27	10
Anti-PSC ≥ 0.3 µg/mL (Post-Booster)	205	64
Anti-PSC ≥ 2 µg/mL (Post-Booster)	183	47
Anti-PSC ≥ 0.3 µg/mL (PIV [M12])	119	29
Anti-PSC ≥ 2 µg/mL (PIV [M12])	19	2

22. Primary Outcome

Title	Concentration of Anti-PSC Antibodies
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

Outcome Measure Data

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
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.
Measure Participants	206	64
Anti-PSC (Pre-Primary)	0.18	0.17
Anti-PSC (Post-Primary)	9.52	11.20
Anti-PSC (Pre-Booster)	0.77	0.84
Anti-PSC (Post-Booster)	7.36	3.51
Anti-PSC (PIV [M12])	0.47	0.32

23. Primary Outcome

Title	Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Description	The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time Frame	At Year 2

Outcome Measure Data

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
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.
Measure Participants	230	76
Anti-PSC ≥ 0.3 µg/mL (Pre-Primary)	26	6
Anti-PSC ≥ 2 µg/mL (Pre-Primary)	12	1
Anti-PSC ≥ 0.3 µg/mL (Post-Primary)	225	72
Anti-PSC ≥ 2 µg/mL (Post-Primary)	224	72
Anti-PSC ≥ 0.3 µg/mL (Pre-Booster)	188	66
Anti-PSC ≥ 2 µg/mL (Pre-Booster)	27	13
Anti-PSC ≥ 0.3 µg/mL (Post-Booster [M1]	230	76
Anti-PSC ≥ 2 µg/mL (Post-Booster) [M1]	210	59
Anti-PSC ≥ 0.3µg/mL (Post-Booster [M12]	110	26
Anti-PSC ≥ 2 µg/mL (Post-Booster [M12])	16	2
Anti-PSC ≥0.3 µg/mL (Post-Booster [M24]	76	17
Anti-PSC ≥ 2 µg/mL (Post-Booster [M24])	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
Description	The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time Frame	At Year 2

Outcome Measure Data

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
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.
Measure Participants	72
Anti-PSC ≥ 0.3 µg/mL (Aged 40-43 mths)	4 1.1%
Anti-PSC ≥2 µg/mL (Aged 40-43 mths)	0 0%

25. Primary Outcome

Title	Concentration of Anti-PSC Antibodies
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

Outcome Measure Data

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
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.
Measure Participants	230	76
Anti-PSC (Pre-Primary)	0.20	0.17
Anti-PSC (Post-Primary)	9.35	12.29
Anti-PSC (Pre-Booster)	0.74	0.87
Anti-PSC (Post-Booster [M1])	7.41	3.91
Anti-PSC (Post-Booster [M12])	0.47	0.32
Anti-PSC (Post-Booster [M24])	0.25	0.21

26. Primary Outcome

Title	Concentration of Anti-PSC Antibodies for Meningitec+Hiberix Group
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

Outcome Measure Data

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
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.
Measure Participants	72
Geometric Mean (95% Confidence Interval) [µg/mL]	0.16

27. Primary Outcome

Title	Number of Subjects With Anti-PSC Antibody Concentrations ≥ 0.3 µg/mL and ≥ 2 µg/mL
Description	The anti-polysaccharide C activity was determined using an Enzyme-linked Immunosorbent Assay (ELISA).
Time Frame	At Year 4

Outcome Measure Data

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
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.
Measure Participants	197	58
Anti-PSC ≥ 0.3 µg/mL (Pre-Primary)	19	3
Anti-PSC ≥ 2 µg/mL (Pre-Primary)	7	1
Anti-PSC ≥ 0.3 µg/mL (Post-Primary)	194	54
Anti-PSC ≥ 2 µg/mL (Post-Primary)	193	54
Anti-PSC ≥ 0.3 µg/mL (Pre-Boost)	163	52
Anti-PSC ≥ 2 µg/mL (Pre-Boost)	24	9
Anti-PSC ≥ 0.3 µg/mL (Post-Boost [M1])	197	58
Anti-PSC ≥ 2 µg/mL (Post-Boost [M1])	179	43
Anti-PSC ≥ 0.3 µg/mL (Post-Boost [M12])	101	22
Anti-PSC ≥ 2 µg/mL (Post-Boost [M12])	15	2
Anti-PSC ≥ 0.3 µg/mL (Post-Boost [M24])	69	10
Anti-PSC ≥ 2 µg/mL (Post-Boost [M24])	5	0
Anti-PSC ≥ 0.3 µg/mL (Post-Boost [M48])	38	4
Anti-PSC ≥ 2 µg/mL (Post-Boost [M48])	6	0

28. Primary Outcome

Title	Concentration of Anti-PSC Antibodies
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

Outcome Measure Data

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
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.
Measure Participants	197	58
Anti-PSC (Pre-Primary)	0.19	0.16
Anti-PSC (Post-Primary)	9.41	11.88
Anti-PSC (Pre-Boost)	0.76	0.85
Anti-PSC (Post-Boost [M1])	7.46	3.76
Anti-PSC (Post-Boost [M12])	0.48	0.34
Anti-PSC (Post-Boost [M24])	0.27	0.19
Anti-PSC (Post-Boost [M48])	0.21	0.17

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)
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

Outcome Measure Data

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
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.
Measure Participants	67	23
Anti-PT Pre-Primary	11	3
Anti-PT Post-Primary (M3)	63	20
Anti-PT Post-Primary (M10)	34	10
Anti-PT Pre-Boost	8	3
Anti-FHA Pre-Primary	40	12
Anti-FHA Post-Primary (M3)	63	20
Anti-FHA Post-Primary (M10)	65	21
Anti-FHA Pre-Boost	47	13
Anti-PRN Pre-Primary	22	4
Anti-PRN Post-Primary (M3)	63	20
Anti-PRN Post-Primary (M10)	53	14
Anti-PRN Pre-Boost	34	7

30. Primary Outcome

Title	Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
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

Outcome Measure Data

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
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.
Measure Participants	67	23
Anti-PT Pre-Primary	3.2	3.3
Anti-PT Post-Primary (M3)	44.8	40.1
Anti-PT Post-Primary (M10)	4.9	4.5
Anti-PT Pre-Boost	2.9	3.0
Anti-FHA Pre-Primary	6.5	7.8
Anti-FHA Post-Primary (M3)	223.5	160.2
Anti-FHA Post-Primary (M10)	30.4	25.8
Anti-FHA Pre-Boost	15.1	20.3
Anti-PRN Pre-Primary	4.2	3.1
Anti-PRN Post-Primary (M3)	116.3	46.1
Anti-PRN Post-Primary (M10)	12.5	6.6
Anti-PRN Pre-Boost	5.9	4.3

31. Primary Outcome

Title	Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations ≥ 5.0 EL.U/mL
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

Outcome Measure Data

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
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.
Measure Participants	44	14
Anti-PT Pre-Primary	9	2
Anti-PT Post-Primary (M3)	42	11
Anti-PT Post-Primary (M10)	24	5
Anti-PT Pre-Boost ( M32)	6	2
Anti-PT Post-Boost ( M24)	30	9
Anti-FHA Pre-Primary	27	9
Anti-FHA Post-Primary (M3)	42	11
Anti-FHA Post-Primary (M10)	43	13
Anti-FHA Pre-Boost ( M32)	29	10
Anti-FHA Post-Boost ( M24)	41	14
Anti-PRN Pre-Primary	13	3
Anti-PRN Post-Primary (M3)	42	11
Anti-PRN Post-Primary (M10)	36	8
Anti-PRN Pre-Boost ( M32)	25	4
Anti-PRN Post-Boost ( M24)	43	14

32. Primary Outcome

Title	Concentration of Anti-PT, Anti-FHA and Anti-PRN Antibodies
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

Outcome Measure Data

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
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.
Measure Participants	44	14
Anti-PT Pre-Primary	3.4	3.4
Anti-PT Post-Primary (M3)	45.2	36.5
Anti-PT Post-Primary (M10)	5.1	3.9
Anti-PT Pre-Boost ( M32)	3.0	3.1
Anti-PT Post-Boost ( M24)	8.2	7.2
Anti-FHA Pre-Primary	7.2	9.1
Anti-FHA Post-Primary (M3)	229.9	169.8
Anti-FHA Post-Primary (M10)	27.2	22.8
Anti-FHA Pre-Boost ( M32)	16.7	33.1
Anti-FHA Post-Boost ( M24)	164.7	66.8
Anti-PRN Pre-Primary	3.9	3.1
Anti-PRN Post-Primary (M3)	135.6	50.4
Anti-PRN Post-Primary (M10)	12.2	5.6
Anti-PRN Pre-Boost ( M32)	6.6	4.9
Anti-PRN Post-Boost ( M24)	102.8	23.4

33. Primary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
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)

Outcome Measure Data

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
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.
Measure Participants	359	117
Number [Subjects]	0	0

34. Primary Outcome

Title	Number of Subjects With SAE(s)
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)

Outcome Measure Data

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
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.
Measure Participants	359	117
Number [Subjects]	0	0

35. Primary Outcome

Title	Number of Subjects With SAE(s)
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)

Outcome Measure Data

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
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.
Measure Participants	359	117
Number [Subjects]	1	0

36. Primary Outcome

Title	Number of Subjects With SAE(s)
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

Outcome Measure Data

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
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.
Measure Participants	70	23	72
Number [Subjects]	1	0	0

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/359 (0%)		0/117 (0%)		0/74 (0%)
Serious Adverse Events
	Menitorix Group		Meningitec Group		Meningitec+Hiberix Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/359 (0.6%)		0/117 (0%)		0/74 (0%)
General disorders
Pyrexia	1/359 (0.3%)		0/117 (0%)		0/74 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/70 (1.4%)		0/23 (0%)		0/74 (0%)
Other (Not Including Serious) Adverse Events
	Menitorix Group		Meningitec Group		Meningitec+Hiberix Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.