Haemophilus Influenzae Type b, Neisseria Meningitidis
Conditions
Keywords
Meningococcal serogroup C diseases, H.influenzae type b diseases
Brief summary
The purpose of the primary phase of the study is to demonstrate the non-inferiority of a single dose of GSK Biologicals' Haemophilus influenzae type b and meningococcal C (Hib-MenC) conjugate vaccine when given in the second year of life to subjects primed in infancy with a Hib vaccine, but not with a meningococcal serogroup C vaccine, versus commercially available Hib and MenC vaccines. In the extension phase, at Years 1, 2, 3, 4 & 5, one blood sample is taken at each year to follow the antibody persistence up to 5 years after vaccination. No additional vaccine is administered during the extension phase. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
This multicenter study is open and has 2 treatment groups with Hiberix™ + a commercially available MenC vaccine as active controls. Priorix™ is given concomitantly in both groups. In the primary phase, two blood samples are taken from all subjects for immunogenicity analyses: before and one month after vaccination. In the extension phase, at Year 1, 2, 3, 4 & 5, one blood sample is taken at each year to follow the antibody persistence up to 5 years after vaccination. No additional vaccine is administered during the extension phase.
Interventions
BIOLOGICALHaemophilus influenzae type b and meningococcal serogroup C (vaccine)
One intramuscular dose at 12-18 months of age
BIOLOGICALPriorix™
One subcutaneous dose at 12-18 months of age
BIOLOGICALHiberix™
One intramuscular dose at 12-18 months of age.
BIOLOGICALMeningitec™
One intramuscular dose at 12-18 months of age
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
Primary phase: * Subjects whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 12 and 18 months of age at the time of vaccination. * Written informed consent obtained from the parent or guardian of the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Previously completed routine childhood vaccinations to the best of his/her parents'/guardians knowledge. * Having completed primary vaccination with two doses of Haemophilus influenzae type b outer membrane protein (Hib-OMP) containing vaccine OR three doses of diphtheria, tetanus, acellular pertussis and Haemophilus influenzae type b (DTPa/Hib) containing vaccine at least 6 months before the study start. Long-term persistence phase: \- Having participated in the vaccination study 106445
Exclusion criteria
For the primary vaccination phase: * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration (defined as more than 14 days) or planned administration of immuno-suppressants or other immune-modifying drugs within six months prior to vaccination. * Planned administration/administration of a vaccine not foreseen by the protocol during the period starting from 30 days before vaccination and ending 30 days after vaccination. * Administration of a meningococcal vaccine not foreseen by the study protocol during the period starting at birth and ending at first dose. * Previous administration of a booster dose of Hib vaccine. * Previous vaccination against measles, mumps, rubella. * History of H. influenzae type b, meningococcal serogroup C and/or confirmed measles, mumps or rubella diseases. * Known exposure to measles, mumps or rubella within 30 days prior to the start of the study. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection. * A family history of congenital or hereditary immunodeficiency. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Major congenital defects or serious chronic illness. * History of neurological disorders or more than one episode of febrile convulsion. * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL) | 1 month after vaccination | Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of short-term protection. |
| Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Greater Than or Equal to 1:8 Titer | 1 month after vaccination | rSBA-MenC titers greater than or equal to 1:8 titer are indicative of seroprotection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers | Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination. | Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the PHE at year 4 after vaccination, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition. |
| Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination | Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection). |
| Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values | Prior to, 1 month, 1 year, 2 years and 3 years after vaccination | Anti-PSC antibody concentration cut-off values assessed include greater than or equal to (≥) 0.30 µg/mL and ≥ 2.0 µg/mL. |
| Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations | Prior to, 1 month , 1 year, 2 years, 3 years and 4 years after vaccination | Concentrations are given as Geometric Mean Concentrations (GMCs). |
| Number of Subjects Reporting Solicited Local and General Symptoms | Within 4 days (Day 0 -Day 3) after vaccination | Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, fever (≥ 38°C), irritability and loss of appetite. |
| Number of Subjects Reporting Unsolicited Symptoms | Within 31 days (Day 0 - Day 30) after vaccination | Unsolicited symptom: Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | Throughout the entire study period (up to year 5) | A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. For the long-term persistence phase (Years 1 through 5), only those SAEs that are determined by the investigator to have a causal relationship to the vaccination will be described individually. |
| Anti-polysaccharide C (Anti-PSC) Antibody Concentrations | Prior to, 1 month, 1 year, 2 years and 3 years after vaccination | Concentrations given as Geometric Mean Concentrations (GMCs). |
| Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination | rSBA-MenC titers cut-off values assessed were greater than or equal to (≥) 1:8 (indicative of seroprotection) and ≥ 1:128 titers. Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the Public Health England (PHE), formerly known as Health Protection Agency (HPA), at Year 4, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition. |
Countries
Australia
Participant flow
Pre-assignment details
Total of subjects completed in the previous period does not necessarily correspond to the amount of subjects who came back for the follow-up. These subjects were considered lost-to-follow-up.
Participants by arm
| Arm | Count |
|---|---|
| Menitorix Group Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm. | 324 |
| Meningitec + Hiberix Group Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm. | 109 |
| Total | 433 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Active Phase | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | Menitorix Group | Meningitec + Hiberix Group | Total |
|---|---|---|---|
| Age, Continuous | 12.5 Months STANDARD_DEVIATION 0.94 | 12.5 Months STANDARD_DEVIATION 0.75 | 12.5 Months STANDARD_DEVIATION 0.9 |
| Sex: Female, Male Female | 150 Participants | 42 Participants | 192 Participants |
| Sex: Female, Male Male | 174 Participants | 67 Participants | 241 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 293 / 324 | 104 / 109 |
| serious Total, serious adverse events | 4 / 324 | 2 / 109 |
Outcome results
Primary
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)
Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of short-term protection.
Time frame: 1 month after vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component for the blood sample taken 1 month after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL) | 292 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL) | 100 Subjects |
Primary
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Greater Than or Equal to 1:8 Titer
rSBA-MenC titers greater than or equal to 1:8 titer are indicative of seroprotection.
Time frame: 1 month after vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component for the blood sample taken 1 month after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Greater Than or Equal to 1:8 Titer | 280 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Greater Than or Equal to 1:8 Titer | 98 Subjects |
Secondary
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs).
Time frame: 5 years after vaccination
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Menitorix Group | Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations | 2.131 microgram per milliliter (µg/mL) |
| Meningitec + Hiberix Group | Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations | 2.537 microgram per milliliter (µg/mL) |
Secondary
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs).
Time frame: Prior to, 1 month , 1 year, 2 years, 3 years and 4 years after vaccination
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menitorix Group | Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations | Prior to vaccination (N=285, 98) | 0.438 microgram per milliliter (µg/mL) |
| Menitorix Group | Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations | 1 month after vaccination (N=292, 100) | 46.652 microgram per milliliter (µg/mL) |
| Menitorix Group | Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations | 1 year after vaccination (N=255, 91) | 3.550 microgram per milliliter (µg/mL) |
| Menitorix Group | Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations | 2 years after vaccination (N= 237, 84) | 2.5 microgram per milliliter (µg/mL) |
| Menitorix Group | Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations | 3 years after vaccination (N= 233, 78) | 2.234 microgram per milliliter (µg/mL) |
| Menitorix Group | Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations | 4 years after vaccination (N= 204, 73) | 2.116 microgram per milliliter (µg/mL) |
| Meningitec + Hiberix Group | Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations | 3 years after vaccination (N= 233, 78) | 2.751 microgram per milliliter (µg/mL) |
| Meningitec + Hiberix Group | Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations | Prior to vaccination (N=285, 98) | 0.472 microgram per milliliter (µg/mL) |
| Meningitec + Hiberix Group | Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations | 2 years after vaccination (N= 237, 84) | 3.3 microgram per milliliter (µg/mL) |
| Meningitec + Hiberix Group | Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations | 1 month after vaccination (N=292, 100) | 73.976 microgram per milliliter (µg/mL) |
| Meningitec + Hiberix Group | Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations | 4 years after vaccination (N= 204, 73) | 2.964 microgram per milliliter (µg/mL) |
| Meningitec + Hiberix Group | Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations | 1 year after vaccination (N=255, 91) | 4.802 microgram per milliliter (µg/mL) |
Secondary
Anti-polysaccharide C (Anti-PSC) Antibody Concentrations
Concentrations given as Geometric Mean Concentrations (GMCs).
Time frame: Prior to, 1 month, 1 year, 2 years and 3 years after vaccination
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 (1, 2, 3 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menitorix Group | Anti-polysaccharide C (Anti-PSC) Antibody Concentrations | 1 month after vaccination (N=290,100) | 18.69 micrograms per milliliter (µg/mL) |
| Menitorix Group | Anti-polysaccharide C (Anti-PSC) Antibody Concentrations | 2 years after vaccination (N= 233, 84) | 0.2 micrograms per milliliter (µg/mL) |
| Menitorix Group | Anti-polysaccharide C (Anti-PSC) Antibody Concentrations | 1 year after vaccination (N=250, 91) | NA micrograms per milliliter (µg/mL) |
| Menitorix Group | Anti-polysaccharide C (Anti-PSC) Antibody Concentrations | 3 years after vaccination (N= 230, 79) | NA micrograms per milliliter (µg/mL) |
| Menitorix Group | Anti-polysaccharide C (Anti-PSC) Antibody Concentrations | Prior to vaccination (N=283, 96) | NA micrograms per milliliter (µg/mL) |
| Meningitec + Hiberix Group | Anti-polysaccharide C (Anti-PSC) Antibody Concentrations | 3 years after vaccination (N= 230, 79) | NA micrograms per milliliter (µg/mL) |
| Meningitec + Hiberix Group | Anti-polysaccharide C (Anti-PSC) Antibody Concentrations | Prior to vaccination (N=283, 96) | NA micrograms per milliliter (µg/mL) |
| Meningitec + Hiberix Group | Anti-polysaccharide C (Anti-PSC) Antibody Concentrations | 1 month after vaccination (N=290,100) | 7.95 micrograms per milliliter (µg/mL) |
| Meningitec + Hiberix Group | Anti-polysaccharide C (Anti-PSC) Antibody Concentrations | 1 year after vaccination (N=250, 91) | NA micrograms per milliliter (µg/mL) |
| Meningitec + Hiberix Group | Anti-polysaccharide C (Anti-PSC) Antibody Concentrations | 2 years after vaccination (N= 233, 84) | 0.2 micrograms per milliliter (µg/mL) |
Secondary
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers
Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
Time frame: 5 years after vaccination
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Menitorix Group | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers | 6.6 Titer |
| Meningitec + Hiberix Group | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers | 8.5 Titer |
Secondary
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers
Titers are given as Geometric Mean Titers (GMTs). Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the PHE at year 4 after vaccination, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
Time frame: Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination.
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menitorix Group | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers | Prior to vaccination (N= 255; 83) | 6.3 Titer |
| Menitorix Group | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers | 1 month after vaccination (N= 281; 98) | 482.8 Titer |
| Menitorix Group | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers | 1 year after vaccination (N= 249; 89) | 91.7 Titer |
| Menitorix Group | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers | 2 years after vaccination (N= 235; 86) | 39.3 Titer |
| Menitorix Group | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers | 3 years after vaccination (N= 226; 77) | 29.8 Titer |
| Menitorix Group | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers | 4 years after vaccination (N=208;73) | 5.3 Titer |
| Meningitec + Hiberix Group | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers | 3 years after vaccination (N= 226; 77) | 21.8 Titer |
| Meningitec + Hiberix Group | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers | Prior to vaccination (N= 255; 83) | 5.5 Titer |
| Meningitec + Hiberix Group | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers | 2 years after vaccination (N= 235; 86) | 30.6 Titer |
| Meningitec + Hiberix Group | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers | 1 month after vaccination (N= 281; 98) | 621.0 Titer |
| Meningitec + Hiberix Group | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers | 4 years after vaccination (N=208;73) | 6.0 Titer |
| Meningitec + Hiberix Group | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers | 1 year after vaccination (N= 249; 89) | 63.8 Titer |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs)
A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. For the long-term persistence phase (Years 1 through 5), only those SAEs that are determined by the investigator to have a causal relationship to the vaccination will be described individually.
Time frame: Throughout the entire study period (up to year 5)
Population: Analysis was performed on vaccinated subjects from the Total Vaccinated Cohort for the Vaccination Phase of the study (up to Month 1) and on the Total Enrolled Cohort up to Year 5, which included all vaccinated subjects in the vaccination phase who came back for the Year 1, Year 2, Year 3 ,Year 4 and/or Year 5 persistence phases of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Vaccination Phase (N=324, 109) | 4 Subjects |
| Menitorix Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Until year 5 (N=295, 100) | 0 Subjects |
| Meningitec + Hiberix Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Vaccination Phase (N=324, 109) | 2 Subjects |
| Meningitec + Hiberix Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Until year 5 (N=295, 100) | 0 Subjects |
Secondary
Number of Subjects Reporting Solicited Local and General Symptoms
Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, fever (≥ 38°C), irritability and loss of appetite.
Time frame: Within 4 days (Day 0 -Day 3) after vaccination
Population: Analysis was performed on the Total Vaccinated Cohort, on vaccinated subjects with available data for the vaccination phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Swelling | 78 Subjects |
| Menitorix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Fever | 76 Subjects |
| Menitorix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Redness | 146 Subjects |
| Menitorix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Irritabily | 154 Subjects |
| Menitorix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Drowsiness | 102 Subjects |
| Menitorix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Loss of appetite | 102 Subjects |
| Menitorix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Pain | 91 Subjects |
| Meningitec + Hiberix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Loss of appetite | 40 Subjects |
| Meningitec + Hiberix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Pain | 42 Subjects |
| Meningitec + Hiberix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Redness | 64 Subjects |
| Meningitec + Hiberix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Swelling | 41 Subjects |
| Meningitec + Hiberix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Drowsiness | 40 Subjects |
| Meningitec + Hiberix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Fever | 30 Subjects |
| Meningitec + Hiberix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Irritabily | 69 Subjects |
Secondary
Number of Subjects Reporting Unsolicited Symptoms
Unsolicited symptom: Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Time frame: Within 31 days (Day 0 - Day 30) after vaccination
Population: Analysis was performed on the Total Vaccinated Cohort, on vaccinated subjects with available data for the vaccination phase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menitorix Group | Number of Subjects Reporting Unsolicited Symptoms | 217 Subjects |
| Meningitec + Hiberix Group | Number of Subjects Reporting Unsolicited Symptoms | 81 Subjects |
Secondary
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).
Time frame: Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 0.15 µg/mL [3 years post-vaccination] (N=233,78) | 231 Subjects |
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 1.0 µg/mL [1 month post-vaccination] (N=292,100) | 286 Subjects |
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 0.15 µg/mL [2 years post-vaccination] (N=237,84) | 235 Subjects |
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 1.0 µg/mL [1 year post-vaccination] (N=255,91) | 209 Subjects |
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 0.15 µg/mL [4 years post-vaccination] (N=204,73) | 202 Subjects |
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 1.0 µg/mL [2 years post-vaccination] (N=237,84) | 174 Subjects |
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 0.15 µg/mL [1 year post-vaccination] (N=255,91) | 252 Subjects |
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 1.0 µg/mL [3 years post-vaccination] (N=233,78) | 164 Subjects |
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 1.0 µg/mL [Prior to vaccination] (N=285,98) | 77 Subjects |
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 1.0 µg/mL [4 years post-vaccination] (N=204,73) | 144 Subjects |
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 0.15 µg/mL [Prior to vaccination] (N=285,98) | 219 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 1.0 µg/mL [4 years post-vaccination] (N=204,73) | 57 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 0.15 µg/mL [Prior to vaccination] (N=285,98) | 82 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 0.15 µg/mL [1 year post-vaccination] (N=255,91) | 91 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 0.15 µg/mL [2 years post-vaccination] (N=237,84) | 84 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 0.15 µg/mL [3 years post-vaccination] (N=233,78) | 77 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 0.15 µg/mL [4 years post-vaccination] (N=204,73) | 73 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 1.0 µg/mL [Prior to vaccination] (N=285,98) | 22 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 1.0 µg/mL [1 month post-vaccination] (N=292,100) | 100 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 1.0 µg/mL [1 year post-vaccination] (N=255,91) | 80 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 1.0 µg/mL [2 years post-vaccination] (N=237,84) | 72 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 1.0 µg/mL [3 years post-vaccination] (N=233,78) | 64 Subjects |
Secondary
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values
Anti-PRP antibody concentration cut-off values assessed include 0.15 µg/mL (indicative of short-term protection) and 1.0 µg/mL (indicative of long-term protection).
Time frame: 5 years after vaccination
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 0.15 µg/mL [5 years post-vaccination] | 191 Subjects |
| Menitorix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 1.0 µg/mL [5 years post-vaccination] | 129 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 0.15 µg/mL [5 years post-vaccination] | 67 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Above Cut-off Values | ≥ 1.0 µg/mL [5 years post-vaccination] | 47 Subjects |
Secondary
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values
Anti-PSC antibody concentration cut-off values assessed include greater than or equal to (≥) 0.30 µg/mL and ≥ 2.0 µg/mL.
Time frame: Prior to, 1 month, 1 year, 2 years and 3 years after vaccination
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 (1, 2, 3 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values | ≥ 0.3 µg/mL [prior to vaccination] (N=283, 96) | 2 Subjects |
| Menitorix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values | ≥ 0.3 µg/mL [1 month post-vaccination] (N=290,100) | 290 Subjects |
| Menitorix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values | ≥ 0.3 µg/mL [1 year post-vaccination] (N=250, 91) | 95 Subjects |
| Menitorix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values | ≥ 0.3 µg/mL [2 years post-vaccination] (N=233,84) | 47 Subjects |
| Menitorix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values | ≥ 0.3 µg/mL [3 years post-vaccination] (N=230,79) | 24 Subjects |
| Menitorix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values | ≥ 2.0 µg/mL [prior to vaccination] (N=283, 96) | 0 Subjects |
| Menitorix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values | ≥ 2.0 µg/mL [1 month post-vaccination] (N=290,100) | 289 Subjects |
| Menitorix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values | ≥ 2.0 µg/mL [1 year post-vaccination] (N=250, 91) | 6 Subjects |
| Menitorix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values | ≥ 2.0 µg/mL [2 years post-vaccination] (N=233,84) | 1 Subjects |
| Menitorix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values | ≥ 2.0 µg/mL [3 years post-vaccination] (N=230,79) | 1 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values | ≥ 2.0 µg/mL [1 year post-vaccination] (N=250, 91) | 0 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values | ≥ 0.3 µg/mL [prior to vaccination] (N=283, 96) | 1 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values | ≥ 2.0 µg/mL [prior to vaccination] (N=283, 96) | 0 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values | ≥ 0.3 µg/mL [1 month post-vaccination] (N=290,100) | 100 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values | ≥ 2.0 µg/mL [3 years post-vaccination] (N=230,79) | 1 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values | ≥ 0.3 µg/mL [1 year post-vaccination] (N=250, 91) | 33 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values | ≥ 2.0 µg/mL [1 month post-vaccination] (N=290,100) | 96 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values | ≥ 0.3 µg/mL [2 years post-vaccination] (N=233,84) | 17 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values | ≥ 2.0 µg/mL [2 years post-vaccination] (N=233,84) | 1 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Above the Cut-off Values | ≥ 0.3 µg/mL [3 years post-vaccination] (N=230,79) | 8 Subjects |
Secondary
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
rSBA-MenC titers cut-off values assessed were greater than or equal to (≥)1:8 (indicative of seroprotection) and 1:128 titers. For SBA testing at the PHE at Year 5, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
Time frame: 5 years after vaccination
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on subjects with available data for at least one tested antigen at the considered time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:8 [5 years after vaccination] | 37 Subjects |
| Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:128 [5 years after vaccination ] | 12 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:8 [5 years after vaccination] | 17 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:128 [5 years after vaccination ] | 7 Subjects |
Secondary
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values
rSBA-MenC titers cut-off values assessed were greater than or equal to (≥) 1:8 (indicative of seroprotection) and ≥ 1:128 titers. Functional anti-meningococcal serogroup C activity (SBA-MenC) was determined by a serum bactericidal test using rabbit complement. For SBA testing at a GlaxoSmithKline (GSK) laboratory up to Year 3 after vaccination, titres were expressed as the reciprocal of the dilution resulting in 50% inhibition. For SBA testing at the Public Health England (PHE), formerly known as Health Protection Agency (HPA), at Year 4, titres were expressed as the reciprocal of the last dilution resulting in at least 50% inhibition.
Time frame: Prior to, 1 month, 1 year, 2 years, 3 years and 4 years after vaccination
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity (prior to and 1 month after vaccination) and the ATP cohort for analysis of persistence for Year 1, 2, 3 and 4 (1, 2, 3 and 4 years after vaccination), on subjects with available data for at least one tested antigen at the considered time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:8 [3 years after vaccination] (N= 226, 77) | 145 Subjects |
| Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:128 [1 month after vaccination] (N=281, 98) | 247 Subjects |
| Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:8 [2 years after vaccination] (N= 235, 86) | 164 Subjects |
| Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:128 [1 year after vaccination] (N=249, 89) | 117 Subjects |
| Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:8 [4 years after vaccination] (N= 208, 73) | 26 Subjects |
| Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:128 [2 years after vaccination] (N= 235, 86) | 76 Subjects |
| Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:8 [1 year after vaccination] (N=249, 89) | 216 Subjects |
| Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:128 [3 years after vaccination] (N= 226, 77) | 58 Subjects |
| Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:128 [Prior to vaccination] (N=255, 83) | 15 Subjects |
| Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:128 [4 years after vaccination] (N= 208, 73) | 7 Subjects |
| Menitorix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:8 [Prior to vaccination] (N=255, 83) | 37 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:128 [4 years after vaccination] (N= 208, 73) | 4 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:8 [Prior to vaccination] (N=255, 83) | 7 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:8 [1 year after vaccination] (N=249, 89) | 68 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:8 [2 years after vaccination] (N= 235, 86) | 52 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:8 [3 years after vaccination] (N= 226, 77) | 41 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:8 [4 years after vaccination] (N= 208, 73) | 9 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:128 [Prior to vaccination] (N=255, 83) | 3 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:128 [1 month after vaccination] (N=281, 98) | 89 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:128 [1 year after vaccination] (N=249, 89) | 37 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:128 [2 years after vaccination] (N= 235, 86) | 26 Subjects |
| Meningitec + Hiberix Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Above the Cut-off Values | ≥ 1:128 [3 years after vaccination] (N= 226, 77) | 22 Subjects |