A Phase 3, Modified Double-blind, Multi-center Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents (2 to 17 Years of Age) in China
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Sanofi
- 入组人数
- 1,602
- 试验地点
- 5
- 主要终点
- Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups W and Y will be assessed in participants receiving MenACYW conjugate vaccine
研究概览
简要总结
This is a Phase 3, modified double-blind, randomized, parallel-group, active-controlled, multicenter study with 2 arms and 4 groups to evaluate the immunogenicity and safety of MenACYW conjugate vaccine in children and adolescents versus control meningococcal vaccines licensed in China.
Study details include:
- The study duration will be approximately 180 days.
- The vaccination visit will be Visit 1.
- The visit frequency will be 2 on-site visits with a 30-day interval. A safety visit/telephone call is planned on the ninth day after the vaccination for all groups; a safety follow-up telephone call is planned for all groups 180 days post the last vaccination.
详细描述
The duration of each participant's participation will be approximately 180 days.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Investigators and study staff as well as Sponsor study staff who conduct the safety assessment and the participant/parent/LAR will not know which study intervention is administered. Only the study staff who prepare and administer the study intervention and are not involved with the safety evaluation will know which study intervention is administered.
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Cohort I: Aged 7 to 17 years on the day of inclusion ("7 to 17 years" means from the day of the 7th birthday to the day before the 18th birthday.). For Cohort II: Aged 2 to 6 years on the day of inclusion (2 to 6 years" means from the day of the 2nd birthday to the day before the 7th birthday.)
- •Participants who are healthy as determined by medical evaluation including medical history and physical examination.
- •A female participant is eligible to participate if she is not pregnant or breastfeeding
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy; or long-term systemic corticosteroid therapy
- •History of meningococcal infection
- •History of any neurologic disorders
- •History of Guillain-Barré syndrome
- •History of an Arthus-type hypersensitivity reaction after a previous dose of tetanus toxoid-containing vaccine
- •At high risk for meningococcal infection during the trial
- •Known systemic hypersensitivity to any of the vaccine components
- •Self-reported thrombocytopenia, contraindicating intramuscular vaccination.
- •Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
- •Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
- •Moderate or severe acute illness/infection
- •Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
- •Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination.
- •The time since last vaccination of meningococcal vaccine was 2 years or less.
- •Receipt of immune globulins, blood or blood-derived products in the past 3 months.
- •Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Group 1 MenACYW1-dose schedule
1 dose of MenACYW conjugate vaccine to participants aged 7 through 17 years of age
干预措施: MenACYW conjugate vaccine (Biological)
Group 2 MenACYW135 Ps 1-dose schedule
1 dose of MenACYW135 polysaccharide vaccine to participants aged 7 through 17 years of age
干预措施: MenACYW135 polysaccharide vaccine (Biological)
Group 3 MenACYW1-dose schedule
1 dose of MenACYW conjugate vaccine to participants aged 2 through 6 years of age
干预措施: MenACYW conjugate vaccine (Biological)
Group 4 Royal MenAC1-dose schedule
1 dose of Royal's MenAC conjugate vaccine to participants aged 2 through 6 years of age
干预措施: MenAC conjugate vaccine (Biological)
结局指标
主要结局
Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups W and Y will be assessed in participants receiving MenACYW conjugate vaccine
时间窗: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days post-vaccination for participants with pre vaccination rSBA titer ≥1:8
Participants 2 through 6 years of age (Cohort II): Vaccine seroresponse to meningococcal serogroups A and C
时间窗: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days postvaccination for participants with pre vaccination rSBA titer ≥1:8
Participants 2 through 6 years of age (Cohort II): Geometric mean titers (GMTs) of antibodies against meningococcal serogroups A and C
时间窗: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
Antibody titers are expressed as geometric mean titers
Participants 2 through 6 years of age (Cohort II): Vaccine seroresponse to meningococcal serogroups W and Y in participants receiving MenACYW conjugate vaccine
时间窗: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
30 days post-vaccination rSBA titer ≥1:8 for participants with pre-vaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30◦days post-vaccination for participants with pre vaccination rSBA titer ≥1:8
Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W
时间窗: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days postvaccination for participants with pre vaccination rSBA titer ≥1:8
Participants 7 through 17 years of age (Cohort I): Geometric mean titers (GMTs) of antibodies against meningococcal serogroups A, C, Y, and W
时间窗: Day 31 (post- vaccination)
Antibodies titers are expressed as geometric mean titers
Participants 2 through 6 years of age (Cohort II): Vaccine seroresponse to meningococcal serogroups A and C
时间窗: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days postvaccination for participants with pre vaccination rSBA titer ≥1:8
Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups W and Y will be assessed in participants receiving MenACYW conjugate vaccine
时间窗: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days post-vaccination for participants with pre vaccination rSBA titer ≥1:8
Participants 2 through 6 years of age (Cohort II): Geometric mean titers (GMTs) of antibodies against meningococcal serogroups A and C
时间窗: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
Antibody titers are expressed as geometric mean titers
Participants 2 through 6 years of age (Cohort II): Vaccine seroresponse to meningococcal serogroups W and Y in participants receiving MenACYW conjugate vaccine
时间窗: Day 01 (pre-vaccination) and Day 31 (post- vaccination)
30 days post-vaccination rSBA titer ≥1:8 for participants with pre-vaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30◦days post-vaccination for participants with pre vaccination rSBA titer ≥1:8
次要结局
- Number of participants with immediate adverse events (AEs)(Within 30 minutes post-vaccination)
- Presence of solicited injection site reactions(Within 7 days post-vaccination)
- Presence of solicited systemic reactions(Within 7 days post-vaccination)
- Presence of unsolicited AEs(Within 30 days post-vaccination)
- Presence of SAEs(Up to Day 181 post-vaccination)
- Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W (Group 1)(Day 01 (pre-vaccination) and Day 31 (post- vaccination))
- Number of participants with immediate adverse events (AEs)(Within 30 minutes post-vaccination)
- Presence of solicited injection site reactions(Within 7 days post-vaccination)
- Presence of unsolicited AEs(Within 30 days post-vaccination)
- Presence of solicited systemic reactions(Within 7 days post-vaccination)
- Presence of SAEs(Up to Day 181 post-vaccination)
- Participants 7 through 17 years of age (Cohort I): Antibody titers against meningococcal serogroups A, C, Y, and W in Groups 1 and 2(Day 01 (pre-vaccination) and Day 31 (post- vaccination))
- Participants 2 through 6 years of age (Cohort II): Antibody titers against meningococcal serogroups A, C, Y, and W in Group 3 and against meningococcal serogroups A and C in Group 4(Day 01 (pre-vaccination) and Day 31 (post- vaccination))
- Participants 2 through 6 years of age (Cohort II): Antibody titers in terms of GMTs against meningococcal serogroups Y and W in Group 3(Day 01 (pre-vaccination) and Day 31 (post- vaccination))