Evaluate Immuno and Safety of GSKBiologicals' HibMenCYTT vs Licensed Hib Conjugate Vaccine, Each Coadministered With Pediarix® and Prevnar®, in Healthy Infants. An Exploratory Control Group Will Receive Licensed Menomune® at 3 to 5 Years
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 756
- 试验地点
- 28
- 主要终点
- Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes
研究概览
简要总结
This study is evaluating the safety and immunogenicity of GSK Biologicals' Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, each administered at 2, 4, and 6 months of age, and compared to licensed meningococcal serogroups A, C, Y, and W-135 polysaccharide vaccine administered at 3 to 5 years of age.
The safety and immunogenicity of a booster dose of Hib-MenCY-TT vaccine will be compared to a booster dose of licensed Hib conjugate vaccine, each administered at 12 to 15 months of age. The group primed with the Hib conjugate vaccine will re-randomized at 12-15 months of age to receive a booster dose of Hib-MenCY-TT or a booster dose of the Hib conjugate vaccine.
详细描述
The non-inferiority of the immunogenicity, safety, and antibody persistence of Hib-MenCY-TT vaccine will be compared to ActHIB®, a monovalent Hib conjugate vaccine licensed in the US.
All subjects will be vaccinated at 2, 4, 6, and 12 to 15 months. The immunogenicity of the MenC and MenY antigens will be summarized.
MenC and MenY immunogenicity will be compared to Menomune® (a quadrivalent meningococcal A, C, Y, and W-135 plain polysaccharide vaccine licensed in the US) administered to children 3 to 5 years of age.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Weeks 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Groups A and B
- •Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
- •Healthy male or female between, and including, 6 and 12 weeks of age at the time of the first 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 the study.
- •Born after a gestation period between 36 and 42 weeks.
- •Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment.
- •For Group C
- •Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
- •Healthy male or female between, and including, 3 and 5 years of age at the time of the first 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 the study.
排除标准
- •For Groups A and B
- •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) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s).
- •Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliovirus, and/or Streptococcus pneumoniae; more than one previous dose of hepatitis B vaccine.
- •History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, poliovirus, and/or Streptococcus pneumoniae disease.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including dry natural latex rubber.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures.
- •Acute disease at time of enrollment.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •For Group C
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the dose of study vaccine.
- •Previous vaccination against Neisseria meningitidis.
- •History of Neisseria meningitidis disease.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including dry natural latex rubber
- •Major congenital defects or serious chronic illness.
- •Acute disease at time of enrollment.
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding vaccination or planned administration during the study period.
研究组 & 干预措施
ActHIB/Menhibrix Group
Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of Menhibrix™ and a concomitant fourth dose of Prevnar™. Menhibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
干预措施: ActHIB (Biological)
MenHibrix Group
Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccinationDuring Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of Menhibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of Menhibrix™ during the Primary Phase received one dose of Menhibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, Menhibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, Menhibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
干预措施: GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine (Biological)
ActHIB/Menhibrix Group
Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of Menhibrix™ and a concomitant fourth dose of Prevnar™. Menhibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
干预措施: Pediarix (Biological)
MenHibrix Group
Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccinationDuring Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of Menhibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of Menhibrix™ during the Primary Phase received one dose of Menhibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, Menhibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, Menhibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
干预措施: Pediarix (Biological)
MenHibrix Group
Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccinationDuring Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of Menhibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of Menhibrix™ during the Primary Phase received one dose of Menhibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, Menhibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, Menhibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
干预措施: Prevnar (Biological)
ActHIB Group
During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either Menhibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
干预措施: Pediarix (Biological)
ActHIB Group
During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either Menhibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
干预措施: ActHIB (Biological)
ActHIB Group
During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either Menhibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
干预措施: Prevnar (Biological)
Menomune Group
Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
干预措施: Pediarix (Biological)
Menomune Group
Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
干预措施: Prevnar (Biological)
Menomune Group
Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
干预措施: Menomune (Biological)
ActHIB/Menhibrix Group
Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of Menhibrix™ and a concomitant fourth dose of Prevnar™. Menhibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
干预措施: GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine (Biological)
ActHIB/Menhibrix Group
Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of Menhibrix™ and a concomitant fourth dose of Prevnar™. Menhibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
干预措施: Prevnar (Biological)
ActHIB/ActHIB Group
Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
干预措施: ActHIB (Biological)
ActHIB/ActHIB Group
Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
干预措施: Pediarix (Biological)
ActHIB/ActHIB Group
Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
干预措施: Prevnar (Biological)
结局指标
主要结局
Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes
时间窗: One month after the 3-dose primary vaccination course (at Month 5)
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations
时间窗: One month after the 3-dose primary vaccination course (at Month 5)
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value.
时间窗: One month after the 3-dose primary vaccination course (at Month 5)
The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value
时间窗: One month after the fourth dose (at Month 11-14)
The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB/ActHIB groups .
Number of Subjects Reporting Any Grade 3 Symptoms
时间窗: During the 4-day follow-up period after each primary vaccine dose
"Symptoms" were defined as solicited local and general symptoms and unsolicited adverse events (AEs). A "Grade 3" symptom was defined as any symptom that prevented normal everyday activity. "Any" was defined as an occurrence of any specified symptom regardless of intensity grade. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
次要结局
- Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers(Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group))
- Number of Subjects Reporting Medically Attended Visits(During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0)
- Number of Subjects Reporting Serious Adverse Events (SAEs)(From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.)
- Anti-polysaccharide C (Anti-PSC) Antibody Concentrations(Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group))
- Anti-PRP Antibody Concentrations(Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14))
- Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values(Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group))
- Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values(Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group))
- Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4(One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group))
- Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values(Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group))
- Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values(Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group))
- Anti-diphtheria and Anti-tetanus Antibody Concentrations(Prior to and one month after the primary vaccination course (at Day 0 and Month 5))
- Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers(Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group))
- Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4(One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group))
- Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations(Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group))
- Number of Subjects Reporting Rash(From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up)
- Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values(Prior to and one month after the primary vaccination course (at Day 0 and Month 5))
- Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL)(Prior to and one month after the primary vaccination course (at Day 0 and Month 5))
- Number of Subjects With Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentration ≥ 10.0 Milli-international Units Per Milliliter (mIU/mL)(Prior to and one month after the primary vaccination course (at Day 0 and Month 5))
- Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL(Prior to and one month after the primary vaccination course (at Day 0 and Month 5))
- Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8(Prior to and one month after the primary vaccination course (at Day 0 and Month 5))
- Anti-poliovirus Types 1, 2 and 3 Antibody Titers(Prior to and one month after the primary vaccination course (at Day 0 and Month 5))
- Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms(Within 8 days (Day 0-7) after fourth dose vaccination)
- Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs)(From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine)
- Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL)(One month after fourth dose vaccination (at Month 11-14))
- Concentration of Antibodies Against Streptococcus Pneumonia Serotypes(One month post fourth dose vaccination (at Month 11-14))
- rSBA-MenC Antibody Titers(Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14))
- Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values(Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14))
- Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentrations(Prior to and one month after the primary vaccination course (at Day 0 and Month 5))
- Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations(Prior to the primary vaccination course (at Day 0))
- Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians' Office, Related or Not to Common Illnesses(From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.)
- Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL)(One month after fourth dose vaccination (at Month 11-14))
- Anti-PSY Antibody Concentrations(Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14))
- Number of Subjects Reporting Large Swelling Reactions of the Injected Limb(s)(Within 4 days (Day 0-3) and within 8 days (Day 0-7) following the fourth dose)
- Number of Subjects With Vaccine Response to PT, FHA and PRN(One month after the 3-dose primary vaccination course (at Month 5))
- Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms(Within 8 days (Day 0-7) after fourth dose vaccination)
- Number of Subjects Reporting Unsolicited Adverse Events (AEs)(During the 31-day follow-up period following the fourth dose)
- Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values(Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14))
- Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values(Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14))
- Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values(Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14))
- Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values(Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14))
- Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values(Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14))
- Number of Subjects Reporting New Onset of Chronic Illness(es)(From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up)
- Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL)(One month after fourth dose vaccination (at Month 11-14))
- Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values(Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14))
- rSBA-MenY Antibody Titers(Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14))
- Anti-PSC Antibody Concentrations(Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14))
- hSBA-MenC Antibody Titers(Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14))
- hSBA-MenY Antibody Titers(Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14))
- Number of Subjects With Anti-tetanus Antibody Concentration Equal to or Above 0.1 International Units Per Milliliter (IU/mL)(Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14))
- Anti-tetanus Antibody Concentrations(Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14))
- Number of Subjects Reporting Emergency Room (ER) Visits or Physicians Office Visits Related or Not to Common Illnesses(From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up)
- Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off(Prior to and one month after the primary vaccination course (at Day 0 and Month 5))
- Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y)(One month post fourth dose vaccination (at Month 11-14))
- Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y)(One month post fourth dose vaccination (at Month 11-14))