Evaluate the Immunogenicity, Reactogenicity, Safety of 4 Different Formulations of GSK Biologicals' Conjugate Vaccine (MenACWY) vs 1 Dose of MenC-CRM197 or Mencevax™ ACWY in Children Aged 12-14 Months & 3-5 Years
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 461
- 试验地点
- 17
- 主要终点
- Number of Subjects With an Immune Response to Different Meningococcal Serogroups
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12-14 months and 3-5 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
The study will enrol subjects of 12 to 14 months of age and subjects of 3 to 5 years of age. 3 formulations of GSK's MenACWY conjugate vaccine will be administered in a double-blind manner, while the 4th one will be single-blinded. Administration of the candidate vaccine or the active controls (MenC-CRM197 or Mencevax™ ACWY) will be done in an open manner. The study will be conducted in two stages: The primary vaccination phase (Study Stage 1) of the study will include all subjects; the second (booster/persistence) phase of the study (Study Stage 2) will include subjects in the active control groups and in the group which was primed with the selected MenACWY formulation.
The study will be conducted in a double-blind manner for groups receiving formulations A, B, C and in single blind manner with respect to the group receiving formulation D. The control vaccines will be administered in an open manner with respect to the investigational vaccination regimens.
Each group will have one blood sample prior to and one blood sample one month after the first vaccine dose.
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 (Care Provider)
入排标准
- 年龄范围
- 12 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 12 and 14 months or 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 into the study.
- •Previously completed routine childhood vaccinations to the best of his/her parents'/guardians' knowledge. For pertussis vaccination, the children aged 12-14 months should have been vaccinated with an acellular pertussis vaccine.
排除标准
- •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 one month of the first dose of vaccine and up to one month after administration of each study vaccine dose with the exception of oral polio vaccine (OPV).
- •Previous vaccination against meningococcal serogroup A, C, W-135 or Y disease.
- •Administration of a H. influenzae type b, diphtheria or tetanus vaccine within 3 months before the first dose of vaccine.
- •For subjects aged 12-14 months at enrolment:
- •For Austria: DTPa-HBV-IPV/Hib booster vaccination in the second year of life: these booster vaccines will be given at Visit
- •For Greece: DTPa-IPV/Hib booster vaccination in the second year of life: these booster vaccines will be given at Visit
- •History of meningococcal serogroup A, C, W-135 or Y disease.
- •Known exposure to meningococcal serogroup A, C, W-135 or Y disease within the previous year.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) 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 any neurologic disorders or seizures.
- •Acute disease at the time of enrolment.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
研究组 & 干预措施
GSK134612A Form1 (T), Primary Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
干预措施: Conjugated meningococcal ACWY-TT (vaccine) (Biological)
GSK134612A Form1 (T), Primary Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
干预措施: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) (Biological)
GSK134612A Form1 (T), Primary Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
干预措施: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) (Biological)
GSK134612A Form1 (T), Primary Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
干预措施: Mencevax™ACWY (Biological)
GSK134612A Form2 (T), Primary Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
干预措施: Conjugated meningococcal ACWY-TT (vaccine) (Biological)
GSK134612A Form2 (T), Primary Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
干预措施: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) (Biological)
GSK134612A Form2 (T), Primary Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
干预措施: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) (Biological)
GSK134612A Form2 (C), Primary Group
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
干预措施: Conjugated meningococcal ACWY-TT (vaccine) (Biological)
GSK134612A Form2 (C), Primary Group
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
干预措施: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) (Biological)
GSK134612A Form2 (C), Primary Group
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
干预措施: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) (Biological)
GSK134612A Form3 (T), Primary Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
干预措施: Conjugated meningococcal ACWY-TT (vaccine) (Biological)
GSK134612A Form3 (T), Primary Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
干预措施: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) (Biological)
GSK134612A Form4 (C), Primary Group
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
干预措施: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) (Biological)
GSK134612A Form3 (T), Primary Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
干预措施: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) (Biological)
GSK134612A Form4 (T), Primary Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
干预措施: Conjugated meningococcal ACWY-TT (vaccine) (Biological)
GSK134612A Form4 (T), Primary Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
干预措施: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) (Biological)
GSK134612A Form4 (T), Primary Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
干预措施: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) (Biological)
Control (T), Primary Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
干预措施: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) (Biological)
Control (T), Primary Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
干预措施: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) (Biological)
Control (T), Primary Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
干预措施: Meningitec™ (Biological)
Control (T), Primary Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
干预措施: Mencevax™ACWY (Biological)
GSK134612A Form1 (C), Primary Group
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
干预措施: Conjugated meningococcal ACWY-TT (vaccine) (Biological)
GSK134612A Form1 (C), Primary Group
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
干预措施: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) (Biological)
GSK134612A Form1 (C), Primary Group
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
干预措施: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) (Biological)
GSK134612A Form3 (C), Primary Group
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
干预措施: Conjugated meningococcal ACWY-TT (vaccine) (Biological)
GSK134612A Form3 (C), Primary Group
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
干预措施: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) (Biological)
GSK134612A Form3 (C), Primary Group
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
干预措施: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) (Biological)
GSK134612A Form4 (C), Primary Group
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
干预措施: Conjugated meningococcal ACWY-TT (vaccine) (Biological)
GSK134612A Form4 (C), Primary Group
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
干预措施: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) (Biological)
Control (C), Primary Group
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
干预措施: Mencevax™ACWY (Biological)
GSK134612A Form1 (T), Booster Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
干预措施: Conjugated meningococcal ACWY-TT (vaccine) (Biological)
GSK134612A Form1 (T), Booster Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
干预措施: Mencevax™ACWY (Biological)
Control (T), Booster Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
干预措施: Meningitec™ (Biological)
Control (T), Booster Group
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
干预措施: Mencevax™ACWY (Biological)
GSK134612A Form1 (C), Booster Group
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
干预措施: Conjugated meningococcal ACWY-TT (vaccine) (Biological)
Control (C), Booster Group
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, did not receive any booster vaccination.
干预措施: Meningitec™ (Biological)
结局指标
主要结局
Number of Subjects With an Immune Response to Different Meningococcal Serogroups
时间窗: One month after the first vaccine dose (Month 1)
A responder to serum bactericidal assay meningococcal serogroups A, C, W and Y, using rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) was defined as follows: -for initially seronegative subjects (antibody titers \< 1:8 for rSBA-Men), a subject achieving a post-vaccination rSBA-Men antibody titer of ≥ 1:32; - for initially seropositive subjects (antibody titers ≥ 1:8 for rSBA-Men), a subject having a ≥ 4-fold increase in rSBA-Men antibody titer from pre to post vaccination.
次要结局
- Antibody Titers Against Different Meningococcal Serogroups(Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination)
- Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides(At one month (M1) and 12 months (M12) post-primary vaccination)
- Number of Seropositive Subjects for Anti-tetanus (Anti-T)(Prior to (Month 0) and one month after (Month 1) the first vaccine dose)
- Antibody Concentrations Against Tetanus (Anti-T)(Prior to (Month 0) and one month after (Month 1) the first vaccine dose)
- Number of Children With Any Solicited Local Symptoms(During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose)
- Number of Toddlers With Any Solicited Local Symptoms(During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose)
- Number of Toddlers With Any Solicited General Symptoms(During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose)
- Number of Seroprotected Subjects Against Different Meningococcal Serogroups(At one month (M1) and 12 months (M12) post-primary vaccination)
- Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides(At one month (M1) and 12 months (M12) post primary vaccination)
- Number of Seropositive Subjects for Different Anti-meningococcal Serogroups(At one month (M1) and 12 months (M12) post-primary vaccination)
- Number of Children With Any Solicited General Symptoms(During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose)
- Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups(Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination)
- Antibody Concentrations Against Different Meningococcal Polysaccharides(Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination)
- Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides(Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination)
- Number of Subjects With Any Solicited General Symptoms(During the 8-day (Days 0-7) post-vaccination period following booster dose)
- Number of Subjects With Any Solicited Local Symptoms(During the 8-day (Days 0-7) post-vaccination period following booster dose)
- Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination(Within 31 days (Days 0-30) after the primary meningococcal vaccination)
- Number of Subjects With SAEs(Since the last study contact in the primary study up to the end of the booster study (from Month 2 up to Month 13))
- Number of Subjects With Any Unsolicited AEs During the Primary Vaccination(Within 31 days (Days 0-30) post-vaccination with diphteria, tetanus and acellular pertusis-containing vaccine, during the primary vaccination)
- Number of Subjects With Any Unsolicited AEs(Within 31 days (Days 0-30) after the booster vaccination)
- Number of Subjects With Serious Adverse Events (SAEs)(During the primary vaccination study (from Month 0 up to Month 2))
- Number of Seroprotected Subjects Against Different Meningococcal Serogroups(Prior to (Month 0) and one month after (Month 1) the first vaccine dose)
- Number of Seropositive Subjects for Different Anti-meningococcal Serogroups(Prior to (Month 0) and one month after (Month 1) after the first vaccine dose)
- Antibody Titers Against Different Meningococcal Serogroups(Prior to (Month 0) and one month after (Month 1) the first vaccine dose)
- Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides(Prior to (Month 0) and one month after (Month 1) the first vaccine dose)
- Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides(Prior to (Month 0) and one month after (Month 1) the first vaccine dose)
- Antibody Concentrations Against Different Meningococcal Polysaccharides(Prior to (Month 0) and one month after (Month 1) the first vaccine dose)
- Antibody Titers Against Different Meningococcal Serogroups(At one month (M1) and 12 months (M12) post-primary vaccination)
- Antibody Concentrations Against Different Meningococcal Polysaccharides(At one month (M1) and 12 months (M12) post-primary vaccination)