Haemophilus Influenzae Type b, Neisseria Meningitidis
Conditions
Keywords
Conjugate vaccine, Persistence, Hib vaccine, Combination vaccine, Meningococcal vaccine, Safety, Preterm/full-term infants, Immunogenicity
Brief summary
The purpose of this Phase IIIb study is to evaluate the immunogenicity, reactogenicity & safety of GSK Biologicals' Hib-MenC vaccine (Menitorix™) when co-administered with GSK Biologicals' DTPa-HBV-IPV vaccine (Infanrix™ penta) & Wyeth's 7-valent pneumococcal conjugate vaccine (Prevenar™) in preterm infants as a 3-dose primary vaccination course during the first 6 months of life (at 2, 4, 6 months of age) and of a booster dose of Menitorix™ when co-administered with GSK Biologicals' DTPa-IPV vaccine (Infanrix IPV) and Wyeth's Prevenar in the second year of life (16-18 months of age). The control is a group of full-term infants receiving the same vaccines. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
This multicenter study is open & consists of a primary & a booster phase. The study has 2 treatment groups (Preterm & Full-term) that will receive the same vaccinations; the Full-term group will be the active control. Four blood samples will be collected from all subjects for immunogenicity analyses; 2 in the primary phase at prior to the first vaccination and one month after the third vaccination and 2 in the booster phase at prior to booster dose and one month after booster dose.
Interventions
BIOLOGICALMenitorix™
Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.
BIOLOGICALInfanrix™ penta
Intramuscular injection, 3 doses in the primary study
BIOLOGICALPrevenar™
Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.
BIOLOGICALInfanrix™ IPV
Intramuscular injection, 1 dose in the Booster study.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
All subjects must satisfy the following criteria at study entry: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 8 and 12 weeks of age at the time of the first vaccination. * Written informed consent obtained from the parent or guardian of the subject. All preterm subjects must satisfy the following criteria at study entry: * Born after a gestation period of less than or equal to 36 weeks (≤258 days). * Medically stable, i.e. do not require significant medical support or ongoing management for debilitating disease and have demonstrated a clinical course of sustained recovery. All full-term subjects must satisfy the following criteria at study entry: * Born after a gestation period between and including 37 and 42 weeks (≥259 days and ≤294 days). * Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* 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 of immunosuppressants or other immune-modifying drugs since birth. * Planned administration/ administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose of vaccine until the last study visit, except measles-mumps-rubella (MMR) and varicella vaccines which may be given according to local immunisation practices and except rotavirus oral vaccine which is allowed at anytime during the study after hospital discharge as per prescribing information. * Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, meningococcal serogroup C and or Streptococcus pneumoniae disease, with the exception of hepatitis B vaccine or BCG vaccine given in the first month of life according to the national recommendations (although BCG and hepatitis B vaccines should have been given outside a 30-day window from the first administration of study vaccines). * History of diphtheria, tetanus, pertussis, polio, hepatitis B, H. influenzae type b, meningococcal disease and or S. pneumoniae disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination. * A family history of congenital or hereditary immunodeficiency. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures. * Acute disease at the time of enrolment. * Administration of immunoglobulins (with the exception of monoclonal antibodies against respiratory syncytial virus \[RSV\]) and/or any blood products within one month (30 days) preceding the first dose of study vaccines. * Planned administration of immunoglobulins and/or any blood products during the active phase of the study. Specific criteria for the booster part of the study (to be checked at Visit 5, study month 14): * History of diphtheria, tetanus, pertussis, polio, hepatitis B, H. influenzae type b, meningococcal disease and or S. pneumoniae disease. * Previous vaccination, except the study vaccines and hepatitis birth dose, against diphtheria, tetanus, pertussis, polio, hepatitis B, H. influenzae type b, meningococcal disease and or S. pneumoniae disease. * Previous booster vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, H. influenzae type b, meningococcal disease and/or S. pneumoniae disease.
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) | One month after the third vaccination | Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of protection. |
| Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:8 | One month after the third vaccination | rSBA-MenC titer greater than or equal to 1:8 is indicative of protection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | Before vaccination (at Day 0) | rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128. |
| Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values | Before vaccination (at Day 0) | Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL. |
| Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values | Before vaccination (at Day 0) | Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL. |
| Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration | Before vaccination (at Day 0) | Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL). |
| Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration | Before vaccination (at Day 0) | Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL). |
| Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer | Before vaccination (at Day 0) | rSBA-MenC titers are given as geometric mean titers (GMTs). |
| Number of Subjects Reporting Solicited Local Symptoms | During the 4-day follow-up period after any primary vaccination dose | Solicited local symptoms assessed include pain, redness and swelling and are presented across doses. |
| Number of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to the Cut-off Values | Before vaccination (at Day 0) | Anti-PRP antibody cut-off values assessed include 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL. |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Within 31 days after each primary vaccination | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | Throughout the entire primary vaccination phase | SAEs assessed include medical occurrences that result in death, is 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. |
| Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Migrogram Per Milliliter (µg/mL) | Prior to (Month 14) and one month after the booster vaccination (Month 15) | Anti-PRP antibody cut-off value assessed was 0.15 migrogram per milliliter (µg/mL). |
| Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1.0 Migrogram Per Milliliter (µg/mL) | Prior to (Month 14) and one month after the booster vaccination (Month 15) | Anti-PRP antibody cut-off value assessed was 1.0 migrogram per milliliter (µg/mL). |
| Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to the Cut-off Values | Prior to (Month 14) and one month after the booster vaccination (Month 15) | Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2.0 µg/mL. |
| Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to the Cut-off Values | Prior to (Month 14) the booster vaccination | Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL. Note: the protocol planned an analysis on HBs after the booster dose, but this analysis was not performed as the vaccines administered as booster doses did not contain HBs component. |
| Number of Subjects Reporting Solicited Symptoms (Local and General) | During the 4-day follow-up period following booster vaccination | Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite. |
| Number of Subjects Reporting Solicited General Symptoms | During the 4-day follow-up period after any primary vaccination dose | Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite and are presented across doses. |
| Number of Subject With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1 Microgram Per Milliliter | One month after the third vaccination | Anti-PRP antibody cut-off value assessed include 1 microgram per milliliter (µg/mL). |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Preterm Group Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age. | 163 |
| Full-term Group Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age. | 150 |
| Total | 313 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Booster Phase | Lost to Follow-up | 3 | 1 |
| Primary Phase | Lost to Follow-up | 0 | 1 |
| Primary Phase | Protocol Violation | 1 | 0 |
| Primary Phase | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Preterm Group | Full-term Group | Total |
|---|---|---|---|
| Age, Continuous | 8.9 weeks STANDARD_DEVIATION 1.15 | 8.8 weeks STANDARD_DEVIATION 0.79 | 8.9 weeks STANDARD_DEVIATION 0.99 |
| Sex: Female, Male Female | 77 Participants | 65 Participants | 142 Participants |
| Sex: Female, Male Male | 86 Participants | 85 Participants | 171 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 153 / 163 | 144 / 150 |
| serious Total, serious adverse events | 22 / 163 | 10 / 150 |
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 protection.
Time frame: One month after the third vaccination
Population: Analysis was performed on the Primary According-to-Protocol (ATP) cohort for immunogenicity, on subjects with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Preterm Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL) | 139 subjects |
| Full-term Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL) | 141 subjects |
Primary
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:8
rSBA-MenC titer greater than or equal to 1:8 is indicative of protection.
Time frame: One month after the third vaccination
Population: Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Preterm Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:8 | 142 subjects |
| Full-term Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:8 | 140 subjects |
Secondary
Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration
Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL).
Time frame: One month after the third dose
Population: Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Preterm Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration | 372.30 mIU/mL |
| Full-term Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration | 586.58 mIU/mL |
Secondary
Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration
Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL).
Time frame: Before vaccination (at Day 0)
Population: Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Preterm Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration | 24.79 mIU/mL |
| Full-term Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration | 16.67 mIU/mL |
Secondary
Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration
Anti-HBs concentrations are given as geometric mean concentrations (GMCs) in milli-international units per milliliter (mIU/mL). Note: Planned analysis in the protocol of HBs after the booster dose was not performed as booster vaccines did not contain HBs component.
Time frame: Prior to (Month 14) the booster vaccination
Population: Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Preterm Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration | 95.9 mIU/mL |
| Full-term Group | Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration | 145.6 mIU/mL |
Secondary
Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration
Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).
Time frame: Before vaccination (at Day 0)
Population: Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Preterm Group | Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration | Anti-PRP (n=140, 138) | 0.116 micrograms per milliliter (µg/mL) |
| Preterm Group | Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration | Anti-PSC (n=142, 137) | 0.19 micrograms per milliliter (µg/mL) |
| Full-term Group | Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration | Anti-PRP (n=140, 138) | 0.140 micrograms per milliliter (µg/mL) |
| Full-term Group | Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration | Anti-PSC (n=142, 137) | 0.25 micrograms per milliliter (µg/mL) |
Secondary
Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration
Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) in micrograms per milliliter (µg/mL).
Time frame: Prior to (Month 14) and one month after the booster vaccination (Month 15)
Population: Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Preterm Group | Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration | anti-PRP pre-booster (n= 133; 130) | 0.706 micrograms per milliliter (µg/mL) |
| Preterm Group | Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration | anti-PRP post-booster (n= 132; 134) | 50.343 micrograms per milliliter (µg/mL) |
| Preterm Group | Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration | anti-PSC post-booster (n= 117; 129) | 10.06 micrograms per milliliter (µg/mL) |
| Preterm Group | Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration | anti-PSC pre-booster (n= 130; 127) | 0.42 micrograms per milliliter (µg/mL) |
| Full-term Group | Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration | anti-PSC post-booster (n= 117; 129) | 11.31 micrograms per milliliter (µg/mL) |
| Full-term Group | Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration | anti-PRP pre-booster (n= 133; 130) | 0.777 micrograms per milliliter (µg/mL) |
| Full-term Group | Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration | anti-PRP post-booster (n= 132; 134) | 54.625 micrograms per milliliter (µg/mL) |
| Full-term Group | Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration | anti-PSC pre-booster (n= 130; 127) | 0.56 micrograms per milliliter (µg/mL) |
Secondary
Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration
Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).
Time frame: One month after the third dose
Population: Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Preterm Group | Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration | Anti-PRP (n= 140, 142) | 10.437 micrograms per milliliter (µg/mL) |
| Preterm Group | Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration | Anti-PSC (n= 140, 141) | 6.34 micrograms per milliliter (µg/mL) |
| Full-term Group | Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration | Anti-PRP (n= 140, 142) | 10.473 micrograms per milliliter (µg/mL) |
| Full-term Group | Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration | Anti-PSC (n= 140, 141) | 7.46 micrograms per milliliter (µg/mL) |
Secondary
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer
rSBA-MenC titers are given as geometric mean titers (GMTs).
Time frame: One month after the third dose
Population: Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Preterm Group | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer | 1055.9 Titer |
| Full-term Group | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer | 1346.2 Titer |
Secondary
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer
rSBA-MenC titers are given as geometric mean titers (GMTs).
Time frame: Prior to (Month 14) and one month after the booster vaccination (Month 15)
Population: Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Preterm Group | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer | Pre-booster (n= 134; 134) | 79.3 titer |
| Preterm Group | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer | Post-booster (n= 133; 137) | 4883.1 titer |
| Full-term Group | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer | Pre-booster (n= 134; 134) | 147.8 titer |
| Full-term Group | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer | Post-booster (n= 133; 137) | 5288.8 titer |
Secondary
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer
rSBA-MenC titers are given as geometric mean titers (GMTs).
Time frame: Before vaccination (at Day 0)
Population: Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Preterm Group | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer | 4.9 Titer |
| Full-term Group | Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer | 5.9 Titer |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, is 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. Period 1 is defined as 31 days after last primary vaccination until administration of booster dose (Month 14). Period 2 is defined as the administration of the booster dose until the end of the study (Month 15).
Time frame: 31 days after last primary vaccination until administration of booster dose (Month 14) and from the administration of the booster dose until the end of the study (Month 15)
Population: Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Period 1 | 10 subjects |
| Preterm Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Period 2 | 1 subjects |
| Full-term Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Period 1 | 2 subjects |
| Full-term Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | Period 2 | 0 subjects |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, is 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: Throughout the entire primary vaccination phase
Population: Analysis was performed on the Primary Total Vaccinated Cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Preterm Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 11 subjects |
| Full-term Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 8 subjects |
Secondary
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite and are presented across doses.
Time frame: During the 4-day follow-up period after any primary vaccination dose
Population: Analysis was performed on the Primary Total Vaccinated Cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Subjects Reporting Solicited General Symptoms | Drowsiness | 111 subjects |
| Preterm Group | Number of Subjects Reporting Solicited General Symptoms | Fever | 89 subjects |
| Preterm Group | Number of Subjects Reporting Solicited General Symptoms | Irritability/fussiness | 128 subjects |
| Preterm Group | Number of Subjects Reporting Solicited General Symptoms | Loss of appetite | 99 subjects |
| Full-term Group | Number of Subjects Reporting Solicited General Symptoms | Loss of appetite | 100 subjects |
| Full-term Group | Number of Subjects Reporting Solicited General Symptoms | Drowsiness | 102 subjects |
| Full-term Group | Number of Subjects Reporting Solicited General Symptoms | Irritability/fussiness | 105 subjects |
| Full-term Group | Number of Subjects Reporting Solicited General Symptoms | Fever | 85 subjects |
Secondary
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling and are presented across doses.
Time frame: During the 4-day follow-up period after any primary vaccination dose
Population: Analysis was performed on the Primary Total Vaccinated Cohort.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Subjects Reporting Solicited Local Symptoms | Pain | 106 subjects |
| Preterm Group | Number of Subjects Reporting Solicited Local Symptoms | Redness | 94 subjects |
| Preterm Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling | 91 subjects |
| Full-term Group | Number of Subjects Reporting Solicited Local Symptoms | Pain | 100 subjects |
| Full-term Group | Number of Subjects Reporting Solicited Local Symptoms | Redness | 123 subjects |
| Full-term Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling | 113 subjects |
Secondary
Number of Subjects Reporting Solicited Symptoms (Local and General)
Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite.
Time frame: During the 4-day follow-up period following booster vaccination
Population: Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Subjects Reporting Solicited Symptoms (Local and General) | Swelling | 67 subjects |
| Preterm Group | Number of Subjects Reporting Solicited Symptoms (Local and General) | Fever | 43 subjects |
| Preterm Group | Number of Subjects Reporting Solicited Symptoms (Local and General) | Redness | 77 subjects |
| Preterm Group | Number of Subjects Reporting Solicited Symptoms (Local and General) | Irritability | 70 subjects |
| Preterm Group | Number of Subjects Reporting Solicited Symptoms (Local and General) | Drowsiness | 33 subjects |
| Preterm Group | Number of Subjects Reporting Solicited Symptoms (Local and General) | Loss of appetite | 34 subjects |
| Preterm Group | Number of Subjects Reporting Solicited Symptoms (Local and General) | Pain | 82 subjects |
| Full-term Group | Number of Subjects Reporting Solicited Symptoms (Local and General) | Loss of appetite | 50 subjects |
| Full-term Group | Number of Subjects Reporting Solicited Symptoms (Local and General) | Pain | 98 subjects |
| Full-term Group | Number of Subjects Reporting Solicited Symptoms (Local and General) | Redness | 109 subjects |
| Full-term Group | Number of Subjects Reporting Solicited Symptoms (Local and General) | Swelling | 94 subjects |
| Full-term Group | Number of Subjects Reporting Solicited Symptoms (Local and General) | Drowsiness | 46 subjects |
| Full-term Group | Number of Subjects Reporting Solicited Symptoms (Local and General) | Fever | 53 subjects |
| Full-term Group | Number of Subjects Reporting Solicited Symptoms (Local and General) | Irritability | 69 subjects |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: Within 31 days after each primary vaccination
Population: Analysis was performed on the Primary Total Vaccinated Cohort.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Preterm Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 56 subjects |
| Full-term Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 72 subjects |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: Within 31 days after the booster vaccination (month 15)
Population: Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Preterm Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 34 subjects |
| Full-term Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 42 subjects |
Secondary
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values
Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.
Time frame: Before vaccination (at Day 0)
Population: Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values | ≥ 10 mIU/mL | 89 subjects |
| Preterm Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values | ≥ 100 mIU/mL | 3 subjects |
| Full-term Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values | ≥ 10 mIU/mL | 78 subjects |
| Full-term Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values | ≥ 100 mIU/mL | 8 subjects |
Secondary
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values
Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.
Time frame: One month after the third dose
Population: Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values | ≥ 10 mIU/mL | 128 subjects |
| Preterm Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values | ≥ 100 mIU/mL | 109 subjects |
| Full-term Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values | ≥ 10 mIU/mL | 129 subjects |
| Full-term Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values | ≥ 100 mIU/mL | 117 subjects |
Secondary
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to the Cut-off Values
Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL. Note: the protocol planned an analysis on HBs after the booster dose, but this analysis was not performed as the vaccines administered as booster doses did not contain HBs component.
Time frame: Prior to (Month 14) the booster vaccination
Population: Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to the Cut-off Values | ≥ 10 mIU/mL pre-booster | 121 subjects |
| Preterm Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to the Cut-off Values | ≥ 100 mIU/mL pre-booster | 61 subjects |
| Full-term Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to the Cut-off Values | ≥ 10 mIU/mL pre-booster | 113 subjects |
| Full-term Group | Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to the Cut-off Values | ≥ 100 mIU/mL pre-booster | 71 subjects |
Secondary
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Migrogram Per Milliliter (µg/mL)
Anti-PRP antibody cut-off value assessed was 0.15 migrogram per milliliter (µg/mL).
Time frame: Prior to (Month 14) and one month after the booster vaccination (Month 15)
Population: Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Migrogram Per Milliliter (µg/mL) | Pre-booster (n= 133; 130) | 116 subjects |
| Preterm Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Migrogram Per Milliliter (µg/mL) | Post-booster (n= 132; 134) | 132 subjects |
| Full-term Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Migrogram Per Milliliter (µg/mL) | Pre-booster (n= 133; 130) | 117 subjects |
| Full-term Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Migrogram Per Milliliter (µg/mL) | Post-booster (n= 132; 134) | 134 subjects |
Secondary
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1.0 Migrogram Per Milliliter (µg/mL)
Anti-PRP antibody cut-off value assessed was 1.0 migrogram per milliliter (µg/mL).
Time frame: Prior to (Month 14) and one month after the booster vaccination (Month 15)
Population: Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1.0 Migrogram Per Milliliter (µg/mL) | Pre-booster (n= 133; 130) | 53 subjects |
| Preterm Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1.0 Migrogram Per Milliliter (µg/mL) | Post-booster (n= 132; 134) | 132 subjects |
| Full-term Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1.0 Migrogram Per Milliliter (µg/mL) | Pre-booster (n= 133; 130) | 53 subjects |
| Full-term Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1.0 Migrogram Per Milliliter (µg/mL) | Post-booster (n= 132; 134) | 134 subjects |
Secondary
Number of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to the Cut-off Values
Anti-PRP antibody cut-off values assessed include 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.
Time frame: Before vaccination (at Day 0)
Population: Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to the Cut-off Values | ≥ 0.15 µg/mL | 38 subjects |
| Preterm Group | Number of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to the Cut-off Values | ≥ 1.0 µg/mL | 5 subjects |
| Full-term Group | Number of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to the Cut-off Values | ≥ 0.15 µg/mL | 43 subjects |
| Full-term Group | Number of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to the Cut-off Values | ≥ 1.0 µg/mL | 9 subjects |
Secondary
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values
Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.
Time frame: Before vaccination (at Day 0)
Population: Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values | ≥ 0.3 µg/mL | 23 subjects |
| Preterm Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values | ≥ 2.0 µg/mL | 3 subjects |
| Full-term Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values | ≥ 0.3 µg/mL | 36 subjects |
| Full-term Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values | ≥ 2.0 µg/mL | 8 subjects |
Secondary
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values
Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.
Time frame: One month after the third dose
Population: Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values | ≥ 0.3 µg/mL | 140 subjects |
| Preterm Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values | ≥ 2.0 µg/mL | 127 subjects |
| Full-term Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values | ≥ 0.3 µg/mL | 141 subjects |
| Full-term Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values | ≥ 2.0 µg/mL | 136 subjects |
Secondary
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to the Cut-off Values
Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2.0 µg/mL.
Time frame: Prior to (Month 14) and one month after the booster vaccination (Month 15)
Population: Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to the Cut-off Values | ≥ 0.3 µg/mL pre-booster (n= 130; 127) | 74 subjects |
| Preterm Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to the Cut-off Values | ≥ 0.3 µg/mL post-booster (n= 117; 129) | 116 subjects |
| Preterm Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to the Cut-off Values | ≥ 2.0 µg/mL pre-booster (n= 130; 127) | 11 subjects |
| Preterm Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to the Cut-off Values | ≥ 2.0 µg/mL post-booster (n= 117; 129) | 105 subjects |
| Full-term Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to the Cut-off Values | ≥ 2.0 µg/mL post-booster (n= 117; 129) | 124 subjects |
| Full-term Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to the Cut-off Values | ≥ 0.3 µg/mL pre-booster (n= 130; 127) | 92 subjects |
| Full-term Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to the Cut-off Values | ≥ 2.0 µg/mL pre-booster (n= 130; 127) | 11 subjects |
| Full-term Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to the Cut-off Values | ≥ 0.3 µg/mL post-booster (n= 117; 129) | 129 subjects |
Secondary
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values
rSBA-MenC titer cut-off values assessed include 1:32 and 1:128.
Time frame: One month after the third vaccination
Population: Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | ≥ 1:32 | 142 subjects |
| Preterm Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | ≥ 1:128 | 135 subjects |
| Full-term Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | ≥ 1:32 | 139 subjects |
| Full-term Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | ≥ 1:128 | 136 subjects |
Secondary
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values
rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128.
Time frame: Prior to (Month 14) and one month after the booster vaccination (Month 15)
Population: Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | ≥ 1:8 pre-booster (n= 134; 134) | 102 subjects |
| Preterm Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | ≥ 1:8 post-booster (n= 133; 137) | 132 subjects |
| Preterm Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | ≥ 1:32 pre-booster (n= 134; 134) | 95 subjects |
| Preterm Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | ≥ 1:32 post-booster (n= 133; 137) | 132 subjects |
| Preterm Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | ≥ 1:128 pre-booster (n= 134; 134) | 69 subjects |
| Preterm Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | ≥ 1:128 post-booster (n= 133; 137) | 131 subjects |
| Full-term Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | ≥ 1:128 pre-booster (n= 134; 134) | 85 subjects |
| Full-term Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | ≥ 1:8 pre-booster (n= 134; 134) | 117 subjects |
| Full-term Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | ≥ 1:32 post-booster (n= 133; 137) | 136 subjects |
| Full-term Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | ≥ 1:8 post-booster (n= 133; 137) | 136 subjects |
| Full-term Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | ≥ 1:128 post-booster (n= 133; 137) | 136 subjects |
| Full-term Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | ≥ 1:32 pre-booster (n= 134; 134) | 115 subjects |
Secondary
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values
rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128.
Time frame: Before vaccination (at Day 0)
Population: Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Preterm Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | ≥ 1:8 | 16 subjects |
| Preterm Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | ≥ 1:32 | 5 subjects |
| Preterm Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | ≥ 1:128 | 0 subjects |
| Full-term Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | ≥ 1:8 | 23 subjects |
| Full-term Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | ≥ 1:32 | 11 subjects |
| Full-term Group | Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values | ≥ 1:128 | 3 subjects |
Secondary
Number of Subject With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1 Microgram Per Milliliter
Anti-PRP antibody cut-off value assessed include 1 microgram per milliliter (µg/mL).
Time frame: One month after the third vaccination
Population: Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Preterm Group | Number of Subject With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1 Microgram Per Milliliter | 133 subjects |
| Full-term Group | Number of Subject With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1 Microgram Per Milliliter | 134 subjects |