Haemophilus Influenzae Type b, Neisseria Meningitidis
Conditions
Keywords
H.influenzae type b Disease
Brief summary
This protocol posting deals with objectives & outcome measures of the extension phase at Months 18, 30, 42, 54 and 66 post booster. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00352963). The objectives & outcome measures of the Booster phase/study are presented in a separate protocol posting (NCT number =NCT00323050). The purpose of this study is to evaluate the persistence of meningococcal serogroup C and Hib antibodies on a yearly basis for a period of 5.5 years after booster vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
This multicenter study is open. No vaccine will be administered during this persistence phase of the study. The subjects were randomized in the primary vaccination study 217744/097 (DTPa-HBV-IPV-097) and will not be further randomized in this study. The study has 3 groups with Meningitec™ primed group as control. The protocol was amended to allow for enrollment of subjects of the Meningitec™ primed control group who were boosted with Meningitec™ after the end of the booster study as per new local reccommendation in Spain.
Interventions
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).
BIOLOGICALInfanrix™ penta
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age
BIOLOGICALInfanrix™ hexa
Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).
BIOLOGICALEngerix-B
Intramuscular injection into the thigh as a birth dose
BIOLOGICALNeisVac-C™
Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age.
BIOLOGICALInfanrix™ IPV/HIB
Intramuscular injection into the thigh as primary vaccination at 4 months of age
BIOLOGICALMeningitec™
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
31 Months to 33 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female in their third year of life at the time of the study initiation for the subjects who enter the study at Visit 1. The subjects who enter the study at Visit 2 should be in their fourth year of life at the time of the study initiation. * 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 Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050). * Subjects who are part of the Meningitec™ control group and who were not enrolled at Visit 1 can be enrolled at Visit 2 if they have completed the booster vaccination study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050) and if they have received a fourth dose of Meningitec™ in their second year of life, after the booster study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050)
Exclusion criteria
* Previous administration of a booster dose of Hib or meningococcal serogroup C except booster study vaccines during the study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097. Subjects who received a 4th dose of Meningitec™ should be included in the study. * History of H. influenzae type b, meningococcal serogroup C diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8 | 18, 30, 42, 54 and 66 months after booster dose (day 0) | The cut-off value for the rSBA-MenC titers was equal to or above 1:8. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section. |
| Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32 | 18, 30, 42, 54 and 66 months after booster dose (day 0) | The cut-off value for the rSBA-MenC titers was equal to or above 1:32. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section. |
| Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128 | 18, 30, 42, 54 and 66 months after booster dose (day 0) | The cut-off value for the rSBA-MenC titers was equal to or above 1:128. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section. |
| rSBA-MenC Titers | 18, 30, 42, 54 and 66 months after booster dose (day 0) | Titers are expressed as Geometric Mean Titers (GMTs). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section. |
| Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter) | 18, 30, 42, 54 and 66 months after the booster dose (day 0) | The cut-off value was an anti-PRP concentration equal to or above 0.15 µg/mL (microgram per milliliter). |
| Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter) | 18, 30, 42, 54 and 66 months after the booster dose (day 0) | The cut-off value was an anti-PRP concentration equal to or above 1.0 µg/mL (microgram per milliliter). |
| Anti-PRP Concentrations | 18, 30, 42, 54 and 66 months after the booster dose (day 0) | Concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL (microgram per milliliter). |
| Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter) | 18, 30, 42, 54 and 66 months after the booster dose (day 0) | The cut-off value was an anti-PSC concentration equal to or above 0.3 µg/mL (microgram per milliliter). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section. |
| Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter) | 18, 30, 42, 54 and 66 months after the booster dose (day 0) | The cut-off value was an anti-PSC concentration equal to or above 2.0 µg/mL (microgram per milliliter). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section. |
| Anti-PSC Concentrations | 18, 30, 42, 54 and 66 months after the booster dose (day 0) | Concentrations for anti-PSC antibody were expressed as GMCs. |
| Number of Subjects With Serious Adverse Events | From last study contact of the booster study (NCT00323050) to Month 66 after booster dose (day 0) | Serious adverse events assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. |
Countries
Spain
Participant flow
Recruitment details
The follow-up timepoints include all subjects who came back for that timepoint. Therefore the amount of subjects who completed the previous timepoint does not correspond with the amount of subjects starting the following time-point per se.
Participants by arm
| Arm | Count |
|---|---|
| Menitorix/Pediarix Group Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. | 58 |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study. | 123 |
| Infanrix Hexa/Meningitec Group Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study. | 57 |
| Total | 238 |
Baseline characteristics
| Characteristic | Menitorix/Pediarix Group | Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Infanrix Hexa/Meningitec Group | Total |
|---|---|---|---|---|
| Age, Continuous | 31.3 Months STANDARD_DEVIATION 0.54 | 31.4 Months STANDARD_DEVIATION 0.64 | 31.5 Months STANDARD_DEVIATION 0.87 | 31.4 Months STANDARD_DEVIATION 0.68 |
| Sex: Female, Male Female | 27 Participants | 55 Participants | 27 Participants | 109 Participants |
| Sex: Female, Male Male | 31 Participants | 68 Participants | 30 Participants | 129 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 58 | 0 / 123 | 0 / 57 |
Outcome results
Primary
Anti-PRP Concentrations
Concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL (microgram per milliliter).
Time frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
Population: Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menitorix/Pediarix Group | Anti-PRP Concentrations | Month 54 (N= 49; 106; 52) | 1.552 µg/mL (microgram per milliliter) |
| Menitorix/Pediarix Group | Anti-PRP Concentrations | Month 18 (N= 56; 122; 3) | 2.921 µg/mL (microgram per milliliter) |
| Menitorix/Pediarix Group | Anti-PRP Concentrations | Month 30 (N= 53; 113; 53) | 1.914 µg/mL (microgram per milliliter) |
| Menitorix/Pediarix Group | Anti-PRP Concentrations | Month 42 (N= 50; 110; 51) | 1.735 µg/mL (microgram per milliliter) |
| Menitorix/Pediarix Group | Anti-PRP Concentrations | Month 66 (N= 47; 101; 47) | 1.602 µg/mL (microgram per milliliter) |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Anti-PRP Concentrations | Month 30 (N= 53; 113; 53) | 3.524 µg/mL (microgram per milliliter) |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Anti-PRP Concentrations | Month 66 (N= 47; 101; 47) | 2.625 µg/mL (microgram per milliliter) |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Anti-PRP Concentrations | Month 42 (N= 50; 110; 51) | 2.986 µg/mL (microgram per milliliter) |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Anti-PRP Concentrations | Month 54 (N= 49; 106; 52) | 2.688 µg/mL (microgram per milliliter) |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Anti-PRP Concentrations | Month 18 (N= 56; 122; 3) | 5.450 µg/mL (microgram per milliliter) |
| Infanrix Hexa/Meningitec Group | Anti-PRP Concentrations | Month 18 (N= 56; 122; 3) | 2.547 µg/mL (microgram per milliliter) |
| Infanrix Hexa/Meningitec Group | Anti-PRP Concentrations | Month 30 (N= 53; 113; 53) | 2.224 µg/mL (microgram per milliliter) |
| Infanrix Hexa/Meningitec Group | Anti-PRP Concentrations | Month 54 (N= 49; 106; 52) | 1.799 µg/mL (microgram per milliliter) |
| Infanrix Hexa/Meningitec Group | Anti-PRP Concentrations | Month 66 (N= 47; 101; 47) | 1.763 µg/mL (microgram per milliliter) |
| Infanrix Hexa/Meningitec Group | Anti-PRP Concentrations | Month 42 (N= 50; 110; 51) | 2.005 µg/mL (microgram per milliliter) |
Primary
Anti-PSC Concentrations
Concentrations for anti-PSC antibody were expressed as GMCs.
Time frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
Population: Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menitorix/Pediarix Group | Anti-PSC Concentrations | Month 54 (N= 46; 105; 52) | 0.24 µg/mL (microgram per milliliter) |
| Menitorix/Pediarix Group | Anti-PSC Concentrations | Month 42 (N= 49; 107; 52) | 0.25 µg/mL (microgram per milliliter) |
| Menitorix/Pediarix Group | Anti-PSC Concentrations | Month 18 (N= 56; 122; 0) | 0.50 µg/mL (microgram per milliliter) |
| Menitorix/Pediarix Group | Anti-PSC Concentrations | Month 30 (N= 52; 108; 53) | 0.26 µg/mL (microgram per milliliter) |
| Menitorix/Pediarix Group | Anti-PSC Concentrations | Month 66 (N= 45; 99; 45) | 0.22 µg/mL (microgram per milliliter) |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Anti-PSC Concentrations | Month 42 (N= 49; 107; 52) | 0.40 µg/mL (microgram per milliliter) |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Anti-PSC Concentrations | Month 18 (N= 56; 122; 0) | 1.01 µg/mL (microgram per milliliter) |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Anti-PSC Concentrations | Month 30 (N= 52; 108; 53) | 0.47 µg/mL (microgram per milliliter) |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Anti-PSC Concentrations | Month 54 (N= 46; 105; 52) | 0.36 µg/mL (microgram per milliliter) |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Anti-PSC Concentrations | Month 66 (N= 45; 99; 45) | 0.29 µg/mL (microgram per milliliter) |
| Infanrix Hexa/Meningitec Group | Anti-PSC Concentrations | Month 66 (N= 45; 99; 45) | 0.22 µg/mL (microgram per milliliter) |
| Infanrix Hexa/Meningitec Group | Anti-PSC Concentrations | Month 54 (N= 46; 105; 52) | 0.26 µg/mL (microgram per milliliter) |
| Infanrix Hexa/Meningitec Group | Anti-PSC Concentrations | Month 18 (N= 56; 122; 0) | 0 µg/mL (microgram per milliliter) |
| Infanrix Hexa/Meningitec Group | Anti-PSC Concentrations | Month 42 (N= 49; 107; 52) | 0.28 µg/mL (microgram per milliliter) |
| Infanrix Hexa/Meningitec Group | Anti-PSC Concentrations | Month 30 (N= 52; 108; 53) | 0.30 µg/mL (microgram per milliliter) |
Primary
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter)
The cut-off value was an anti-PRP concentration equal to or above 0.15 µg/mL (microgram per milliliter).
Time frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
Population: Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix/Pediarix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter) | Month 54 (N= 49; 106; 52) | 49 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter) | Month 42 (N= 50; 110; 51) | 50 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter) | Month 18 (N= 56; 122; 3) | 56 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter) | Month 30 (N= 53; 113; 53) | 53 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter) | Month 66 (N= 47; 101; 47) | 47 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter) | Month 42 (N= 50; 110; 51) | 109 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter) | Month 18 (N= 56; 122; 3) | 121 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter) | Month 30 (N= 53; 113; 53) | 112 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter) | Month 54 (N= 49; 106; 52) | 105 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter) | Month 66 (N= 47; 101; 47) | 101 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter) | Month 66 (N= 47; 101; 47) | 46 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter) | Month 54 (N= 49; 106; 52) | 52 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter) | Month 18 (N= 56; 122; 3) | 3 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter) | Month 42 (N= 50; 110; 51) | 51 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 0.15 µg/mL (Microgram Per Milliliter) | Month 30 (N= 53; 113; 53) | 53 subjects |
Primary
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter)
The cut-off value was an anti-PRP concentration equal to or above 1.0 µg/mL (microgram per milliliter).
Time frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
Population: Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix/Pediarix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter) | Month 54 (N= 49; 106; 52) | 27 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter) | Month 42 (N= 50; 110; 51) | 33 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter) | Month 18 (N= 56; 122; 3) | 44 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter) | Month 30 (N= 53; 113; 53) | 36 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter) | Month 66 (N= 47; 101; 47) | 26 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter) | Month 42 (N= 50; 110; 51) | 91 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter) | Month 18 (N= 56; 122; 3) | 112 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter) | Month 30 (N= 53; 113; 53) | 98 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter) | Month 54 (N= 49; 106; 52) | 86 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter) | Month 66 (N= 47; 101; 47) | 84 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter) | Month 66 (N= 47; 101; 47) | 26 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter) | Month 54 (N= 49; 106; 52) | 35 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter) | Month 18 (N= 56; 122; 3) | 3 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter) | Month 42 (N= 50; 110; 51) | 34 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Concentrations Equal to or Above Cut-off Value of 1.0 µg/mL (Microgram Per Milliliter) | Month 30 (N= 53; 113; 53) | 40 subjects |
Primary
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter)
The cut-off value was an anti-PSC concentration equal to or above 0.3 µg/mL (microgram per milliliter). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Time frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
Population: Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix/Pediarix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter) | Month 54 (N= 46; 105; 52) | 14 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter) | Month 42 (N= 49; 107; 52) | 17 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter) | Month 18 (N= 56; 122; 0) | 38 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter) | Month 30 (N= 52; 108; 53) | 19 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter) | Month 66 (45; 99; 45) | 12 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter) | Month 42 (N= 49; 107; 52) | 52 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter) | Month 18 (N= 56; 122; 0) | 100 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter) | Month 30 (N= 52; 108; 53) | 58 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter) | Month 54 (N= 46; 105; 52) | 52 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter) | Month 66 (45; 99; 45) | 34 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter) | Month 66 (45; 99; 45) | 11 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter) | Month 54 (N= 46; 105; 52) | 17 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter) | Month 18 (N= 56; 122; 0) | 0 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter) | Month 42 (N= 49; 107; 52) | 17 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 0.3 µg/mL (Microgram Per Milliliter) | Month 30 (N= 52; 108; 53) | 19 subjects |
Primary
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter)
The cut-off value was an anti-PSC concentration equal to or above 2.0 µg/mL (microgram per milliliter). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Time frame: 18, 30, 42, 54 and 66 months after the booster dose (day 0)
Population: Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix/Pediarix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter) | Month 54 (N= 46; 105; 52) | 1 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter) | Month 42 (N= 49; 107; 52) | 0 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter) | Month 18 (N= 56; 122; 0) | 1 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter) | Month 30 (N= 52; 108; 53) | 1 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter) | Month 66 (N= 45; 99; 45) | 0 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter) | Month 42 (N= 49; 107; 52) | 14 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter) | Month 18 (N= 56; 122; 0) | 31 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter) | Month 30 (N= 52; 108; 53) | 18 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter) | Month 54 (N= 46; 105; 52) | 10 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter) | Month 66 (N= 45; 99; 45) | 8 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter) | Month 66 (N= 45; 99; 45) | 0 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter) | Month 54 (N= 46; 105; 52) | 1 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter) | Month 18 (N= 56; 122; 0) | 0 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter) | Month 42 (N= 49; 107; 52) | 2 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Concentrations Equal to or Above Cut-off Value of 2.0 µg/mL (Microgram Per Milliliter) | Month 30 (N= 52; 108; 53) | 3 subjects |
Primary
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128
The cut-off value for the rSBA-MenC titers was equal to or above 1:128. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Time frame: 18, 30, 42, 54 and 66 months after booster dose (day 0)
Population: Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix/Pediarix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128 | Month 54 (N= 49; 106; 51) | 27 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128 | Month 42 (N= 50; 110; 52) | 30 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128 | Month 18 (N= 45; 96; 0) | 27 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128 | Month 30 (N= 48; 101; 45) | 27 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128 | Month 66 (N= 46; 101; 46) | 28 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128 | Month 42 (N= 50; 110; 52) | 89 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128 | Month 18 (N= 45; 96; 0) | 82 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128 | Month 30 (N= 48; 101; 45) | 80 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128 | Month 54 (N= 49; 106; 51) | 86 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128 | Month 66 (N= 46; 101; 46) | 69 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128 | Month 66 (N= 46; 101; 46) | 18 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128 | Month 54 (N= 49; 106; 51) | 15 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128 | Month 18 (N= 45; 96; 0) | 0 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128 | Month 42 (N= 50; 110; 52) | 13 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:128 | Month 30 (N= 48; 101; 45) | 12 subjects |
Primary
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32
The cut-off value for the rSBA-MenC titers was equal to or above 1:32. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Time frame: 18, 30, 42, 54 and 66 months after booster dose (day 0)
Population: Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix/Pediarix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32 | Month 54 (N= 49; 106; 51) | 37 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32 | Month 42 (N= 50; 110; 52) | 38 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32 | Month 18 (N= 45; 96; 0) | 40 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32 | Month 30 (N= 48; 101; 45) | 36 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32 | Month 66 (N= 46; 101; 46) | 37 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32 | Month 42 (N= 50; 110; 52) | 100 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32 | Month 18 (N= 45; 96; 0) | 93 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32 | Month 30 (N= 48; 101; 45) | 94 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32 | Month 54 (N= 49; 106; 51) | 100 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32 | Month 66 (N= 46; 101; 46) | 88 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32 | Month 66 (N= 46; 101; 46) | 25 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32 | Month 54 (N= 49; 106; 51) | 29 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32 | Month 18 (N= 45; 96; 0) | 0 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32 | Month 42 (N= 50; 110; 52) | 30 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:32 | Month 30 (N= 48; 101; 45) | 25 subjects |
Primary
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8
The cut-off value for the rSBA-MenC titers was equal to or above 1:8. 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Time frame: 18, 30, 42, 54 and 66 months after booster dose (day 0)
Population: Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix/Pediarix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8 | Month 54 (N= 49; 106; 51) | 38 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8 | Month 42 (N= 50; 110; 52) | 39 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8 | Month 18 (N= 45; 96; 0) | 44 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8 | Month 30 (N= 48; 101; 45) | 39 subjects |
| Menitorix/Pediarix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8 | Month 66 (N= 46; 101; 46) | 38 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8 | Month 42 (N= 50; 110; 52) | 106 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8 | Month 18 (N= 45; 96; 0) | 93 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8 | Month 30 (N= 48; 101; 45) | 96 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8 | Month 54 (N= 49; 106; 51) | 103 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8 | Month 66 (N= 46; 101; 46) | 95 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8 | Month 66 (N= 46; 101; 46) | 28 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8 | Month 54 (N= 49; 106; 51) | 33 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8 | Month 18 (N= 45; 96; 0) | 0 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8 | Month 42 (N= 50; 110; 52) | 33 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Equal to or Above Cut-off Value of 1:8 | Month 30 (N= 48; 101; 45) | 31 subjects |
Primary
Number of Subjects With Serious Adverse Events
Serious adverse events assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: From last study contact of the booster study (NCT00323050) to Month 66 after booster dose (day 0)
Population: Analysis was performed on the Total Cohort, which included all vaccinated subjects in the booster study (NC00323050) and who came back during the follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menitorix/Pediarix Group | Number of Subjects With Serious Adverse Events | 0 subjects |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | Number of Subjects With Serious Adverse Events | 0 subjects |
| Infanrix Hexa/Meningitec Group | Number of Subjects With Serious Adverse Events | 0 subjects |
Primary
rSBA-MenC Titers
Titers are expressed as Geometric Mean Titers (GMTs). 0 has been put as an arbitrary value for Month 18 in the Infanrix Hexa/Meningitec Group, as it was not addressed for reasons explained in the participant flow section.
Time frame: 18, 30, 42, 54 and 66 months after booster dose (day 0)
Population: Analysis was performed on the According-to-Protocol Cohort for antibody persistence, which included all subjects with evaluable data at each timepoint and who participated in the primary study (NCT00352963) and booster study (NCT00323050).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menitorix/Pediarix Group | rSBA-MenC Titers | Month 54 (N= 49; 106; 51) | 90.4 titer |
| Menitorix/Pediarix Group | rSBA-MenC Titers | Month 42 (N= 50; 110; 52) | 98.9 titer |
| Menitorix/Pediarix Group | rSBA-MenC Titers | Month 18 (N= 45; 96; 0) | 221.5 titer |
| Menitorix/Pediarix Group | rSBA-MenC Titers | Month 30 (N= 48; 101; 45) | 109.1 titer |
| Menitorix/Pediarix Group | rSBA-MenC Titers | Month 66 (N= 46; 101; 46) | 121.5 titer |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | rSBA-MenC Titers | Month 42 (N= 50; 110; 52) | 409.8 titer |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | rSBA-MenC Titers | Month 18 (N= 45; 96; 0) | 801.1 titer |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | rSBA-MenC Titers | Month 30 (N= 48; 101; 45) | 441.7 titer |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | rSBA-MenC Titers | Month 54 (N= 49; 106; 51) | 344.6 titer |
| Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group | rSBA-MenC Titers | Month 66 (N= 46; 101; 46) | 227.6 titer |
| Infanrix Hexa/Meningitec Group | rSBA-MenC Titers | Month 66 (N= 46; 101; 46) | 42.7 titer |
| Infanrix Hexa/Meningitec Group | rSBA-MenC Titers | Month 54 (N= 49; 106; 51) | 36.7 titer |
| Infanrix Hexa/Meningitec Group | rSBA-MenC Titers | Month 18 (N= 45; 96; 0) | 0 titer |
| Infanrix Hexa/Meningitec Group | rSBA-MenC Titers | Month 42 (N= 50; 110; 52) | 36.1 titer |
| Infanrix Hexa/Meningitec Group | rSBA-MenC Titers | Month 30 (N= 48; 101; 45) | 40.3 titer |