A Phase 3, Modified-double Blind, Multi-center Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers (2 to 23 Months of Age) in China
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 4,568
- 试验地点
- 3
- 主要终点
- Participants 12 through 23 MoA (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W
研究概览
简要总结
The purpose of this study is to describe the safety and immunogenicity of MenACYW conjugate vaccine compared with locally-licensed meningococcal vaccines in healthy infants and toddlers in China.
Study details include:
- Study duration (including 6-month safety follow-up after the last dose):
- Cohort I (Groups 1 and 2): approximately 211 or 271 days (approximately 7 or 9 months)
- Cohort II (Groups 3 and 4): up to 18 months
- Cohort III (Groups 5 and 6): up to 21 months
- Cohort III (Group 7): approximately 16 months
- Vaccination Visits Period:
- Cohort I (Groups 1 and 2): a 2-dose vaccination at V01 (D01) and V02 (D31) or V03 (D91).
Two blood samples are collected pre-vaccination (D01) and 30 days post the 2nd dose of vaccination (D61 or D121). Telephone calls (TCs) are planned on the 4th, the 9th, and the 21st day after each vaccination, and 5 TCs (1 TC/month) are planned for the 5 months post the last on-site visit for safety follow-up. For participants receiving the second vaccination with a 3-month interval: an on-site visit is planned 30 days post the 1st dose of vaccination (V02, D31) for participant diary collection.
- Cohort II (Groups 3 and 4): a 2-dose vaccination at V01 (D01) and V02 (D31) or V03 (D91). A 1-dose booster is planned for Group 3 only at 18 MoA (within the 18th month from the participant's birth date).
Up to 4 blood samples will be collected. In the primary vaccination period, blood samples are collected before the first primary vaccination (D01) and 30 days post the 2nd dose of primary vaccination (D61 or D121). A blood sample will be collected from all participants at 18 MoA. A post-booster blood sample will be collected from participants in Group 3, 30 days post their booster vaccination.
Telephone calls are planned on the 4th, the 9th, and the 21st day after each vaccination (including the booster dose), and 5 TCs (1 TC/month) are planned for the 5 months post the last on-site visit of the primary and the booster vaccination periods, respectively, for safety follow-up.
For participants receiving the second vaccination with a 3-month interval: an on-site visit is planned 30 days post the 1st dose of vaccination (V02, D31) for participant diary collection.
- Cohort III - Groups 5 and 6: a 3-dose primary vaccination at V01 (D01), V02 (D31) and V03 (D61), a 1-dose booster at 12 MoA (within the 12th months from the participant's birth date) on V05 or at 18 MoA (within the 18th months from the participant's birth date) on V06.
In total 4 blood samples are to be collected. In the primary vaccination period, blood samples are to be collected before the first primary vaccination (D01) and 30 days post the 3rd dose of primary vaccination (D91); in the booster vaccination period, blood samples are to be collected before booster vaccination at V05 (for participants receiving the booster at 12 MoA) or V06 (for participants receiving the booster at 18 MoA), and 30 days post booster vaccination (V05 + 30 days or V06 + 30 days).
Telephone calls are planned on the 4th, the 9th, and the 21st day after each vaccination (including the booster dose), and 5 TCs (1 TC/month) are planned for the 5 months post the last on-site visit of the primary and the booster vaccination periods respectively for safety follow-up.
- Cohort III - Group 7: a 3-dose primary vaccination at V01 (D01), V02 (D61) and V03 (D121), a 1-dose booster at V05 at 12 MoA (within the 12th months from the participant's birth date).
In total 4 blood samples are to be collected. In the primary vaccination period, blood samples are to be collected before the first primary vaccination (D01) and 30 days post the 3rd dose of primary vaccination (D151); in the booster vaccination period, blood samples are to be collected before booster vaccination at V05 and 30 days post booster vaccination (V06).
Telephone calls are planned on the 4th, the 9th, and the 21st day after each vaccination (including the booster dose), and 5 TCs (1 TC/month) are planned for the 5 months post the last on-site visit of the primary and the booster vaccination periods (ie, V04 and V06), respectively, for safety follow-up. A safety visit is planned on the 9th day after the first vaccination for the ESDR participants (the first 30 participants in this group).
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
[Specify Complex Masking]
入排标准
- 年龄范围
- 2 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Cohort I: Aged 12 months through 23 months on the day of inclusion. For Cohort II: Aged 6 months through 11 months on the day of inclusion. For Cohort III: Aged 2 months through 5 months on the day of inclusion
- •Born at full term of pregnancy (≥37 weeks) or born after a gestation period of 27 through 36 weeks and medically stable as assessed by the investigator
- •Informed consent form has been signed and dated by the parent(s) or other LAR (and by an independent witness if required by local regulations).
- •Participant and parent/LAR are able to attend all scheduled visits and to comply with all study procedures.
排除标准
- •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 neurological 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 study
- •Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
- •Self-reported thrombocytopenia, contraindicating intramuscular injection
- •Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection
- •Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- •Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (axillary temperature ≥37.5°C [99.5℉]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
- •Receipt of any live vaccines within 14 days preceding the trial vaccination or planned receipt of any live vaccines in 14 days following trial vaccination, and receipt of any inactivated vaccines in 8 days preceding the trial vaccination or planned receipt of any live vaccines in 8 days following trial vaccination
- •For Cohort I (12 to 23 MoA): receipt of any other meningococcal vaccine except the meningococcal group A polysaccharide vaccine included in the NIP. The time since last vaccination of meningococcal group A or groups A and C polysaccharide vaccine of 6 months or less should be excluded.
- •For Cohorts II (6 to 11 MoA) and III (2 to 5 MoA): a vaccination history of any meningococcal vaccine.
- •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.
- •Participation at the time of study enrollment (or in the 4 weeks preceding the study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
- •In an emergency setting, or being hospitalized
- •Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究组 & 干预措施
Cohort I: Group 1MenACYW 2-dose schedule
2 doses of MenACYW conjugate vaccine to participants aged 12 through 23 MoA
干预措施: MenQuadfi® (Meningococcal Polysaccharide [Serogroups A, C, W, and Y] Tetanus Toxoid Conjugate Vaccine) (Sanofi Pasteur Inc., Swiftwater, PA, USA) (Biological)
Cohort I: Group 2 MenACYW135, CanSino 2-dose schedule
2 doses of MenACYW135, CanSino conjugate vaccine to participants aged 12 through 23 MoA
干预措施: Menhycia® (ACYW135 Meningococcal Conjugate Vaccine [CRM197]) (CanSino Biologics Inc., China) (Biological)
Cohort III: Group 5 MenACYW 3-dose primary vaccination + 1-dose booster schedule
3-dose primary vaccination and 1-dose booster of MenACYW conjugate vaccine to participants aged 3 through 5 MoA
干预措施: MenQuadfi® (Meningococcal Polysaccharide [Serogroups A, C, W, and Y] Tetanus Toxoid Conjugate Vaccine) (Sanofi Pasteur Inc., Swiftwater, PA, USA) (Biological)
Cohort III: Group 6 MenACYW135, CanSino 3-dose primary vaccination + 1-dose booster schedule
3-dose primary vaccination and 1-dose booster of MenACYW135, CanSino conjugate vaccine to participants aged 3 through 5 MoA
干预措施: Menhycia® (ACYW135 Meningococcal Conjugate Vaccine [CRM197]) (CanSino Biologics Inc., China) (Biological)
Cohort III: Group 7 MenACYW 3-dose primary vaccination + 1-dose booster schedule
3-dose primary vaccination and 1-dose booster of MenACYW conjugate vaccine to participants aged 2 MoA
干预措施: MenQuadfi® (Meningococcal Polysaccharide [Serogroups A, C, W, and Y] Tetanus Toxoid Conjugate Vaccine) (Sanofi Pasteur Inc., Swiftwater, PA, USA) (Biological)
Cohort II: Group 3MenACYW 2-dose primary vaccination + 1-dose booster schedule
2-dose primary vaccination and 1-dose booster of MenACYW conjugate vaccine to participants aged 6 through 11 MoA
干预措施: MenQuadfi® (Meningococcal Polysaccharide [Serogroups A, C, W, and Y] Tetanus Toxoid Conjugate Vaccine) (Sanofi Pasteur Inc., Swiftwater, PA, USA) (Biological)
Cohort II: Group 4 MenACYW135, CanSino 2-dose schedule
2-dose primary vaccination and 1-dose booster of MenACYW135, CanSino conjugate vaccine to participants aged 6 through 11 MoA
干预措施: Menhycia® (ACYW135 Meningococcal Conjugate Vaccine [CRM197]) (CanSino Biologics Inc., China) (Biological)
结局指标
主要结局
Participants 12 through 23 MoA (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W
时间窗: 30 days post 2nd vaccination (up to Day 121)
30 days post-2nd 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-2nd vaccination for participants with pre-vaccination rSBA titer ≥1:8
Participants 12 through 23 MoA (Cohort I): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W measured by rSBA
时间窗: 30 days post 2nd vaccination (up to Day 121)
30 days (+10 days) post-2nd vaccination with MenACYW conjugate vaccine or MenACYW135, CanSino conjugated vaccine
Participants 6 through 11 MoA (Cohort II): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W
时间窗: 30 days post 2nd vaccination (up to Day 121)
30 days post-2nd 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-2nd vaccination for participants with pre-vaccination rSBA titer ≥1:8
Participants 6 through 11 MoA (Cohort II): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA
时间窗: 30 days post 2nd vaccination (up to Day 121)
30 days (+10 days) post-2nd vaccination of the primary series with MenACYW conjugate vaccine or MenACYW135, CanSino conjugated vaccine
Participants 3 through 5 MoA (Cohort III -Groups 5 and 6): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W
时间窗: Day 91
30 days post-3rd 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-3rd vaccination for participants with pre-vaccination rSBA titer ≥1:8
Participants 3 through 5 MoA (Cohort III -Groups 5 and 6): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA
时间窗: Day 91
30 days (+10 days) post-3rd vaccination of the primary series with MenACYW conjugate vaccine or MenACYW135, CanSino conjugate vaccine
Participants 2 through 5 MoA (Cohort III - Groups 7 and 6): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W
时间窗: Day 151
30 days post-3rd 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-3rd vaccination for participants with pre-vaccination rSBA titer ≥1:8
Participants 2 through 5 MoA (Cohort III - Groups 7 and 6): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA
时间窗: Day 151
30 days (+10 days) post-3rd vaccination of the primary series with MenACYW conjugate vaccine (Group 7) or MenACYW135, CanSino conjugate vaccine (Group 6)
次要结局
- Presence of SAEs(Approximately 7 months to 9 months for Group 1 and Group 2; up to 18 months for participants from Group 3 and Group 4; up to 21◦months for participants from Group 5 and Group 6; Approximately 16 months for participants from Group 7)
- Presence of AEs leading to study discontinuation(Approximately 7 months to 9 months for Group 1 and Group 2; up to 18 months for participants from Group 3 and Group 4; up to 21◦months for participants from Group 5 and Group 6; Approximately 16 months for participants from Group 7)
- Participants 2 MoA (Cohort III - Group 7): Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W measured by rSBA 30 days (+10 days) post-3rd vaccination of the primary series with MenACYW conjugate vaccine (Group 7).(D151)
- Participants 2 MoA (Cohort III - Group 7): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA pre-booster dose at 12 MoA (Group 7) with MenACYW conjugate vaccine(at 12 MoA (up to Day 333))
- Participants 2 MoA (Cohort III - Group 7): Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W, measured by rSBA pre-booster dose at 12 MoA (Group 7) with MenACYW conjugate vaccine(at 12 MoA (up to Day 333))
- Participants 2 MoA (Cohort III - Group 7): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA 30 days (+10 days) post-booster vaccination with MenACYW conjugate vaccine at 12 MoA (Group 7)(30 days after 12 MoA (up to Day 363))
- Participants 2 MoA (Cohort III - Group 7): Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W, measured by rSBA 30 days (+10 days) post-booster vaccination with MenACYW conjugate vaccine at 12 MoA (Group 7)(30 days after 12 MoA (up to Day 363))
- Presence of unsolicited AEs(for 30 days including the day of each study vaccination.)
- Number of participants with immediate adverse events (AEs)(Within 30 minutes post-vaccination)
- Presence of solicited injection site reactions(for 8 days, including the day of each study vaccination.)
- Presence of solicited systemic reactions(for 8 days, including the day of each study vaccination.)
- Participants 12 through 23 MoA (Cohort I) Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W measured by rSBA 30 days (+10 days) post-2nd vaccination with MenACYW conjugate vaccine or MenACYW135, CanSino conjugate vaccine.(30 days post 2nd vaccination (up to Day 121))
- Participants 6 through 11 MoA (Cohort II) Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W measured by rSBA(30 days post 2nd vaccination (up to Day 121))
- Participants 6 through 11 MoA (Cohort II) Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA pre-booster dose at 18 MoA.(at 18 MoA (up to Day 394))
- Participants 6 through 11 MoA (Cohort II) Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W measured by rSBA pre-booster dose at 18 MoA(at 18 MoA (up to Day 394))
- Participants 6 through 11 MoA (Cohort II) Antibody titers (in terms of GMTs) against booster meningococcal serogroups A, C, Y, and W, measured by rSBA 30 days (+10 days) post-booster vaccination with MenACYW conjugate vaccine given at 18 MoA.(at 18 MoA (up to Day 424))
- Participants 6 through 11 MoA (Cohort II) Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W measured by rSBA 30 days (+10 days) after one dose of booster vaccination of MenACYW conjugate vaccine(at 18 MoA (up to Day 424))
- Participants 3 through 5 MoA (Cohort III -Groups 5 and 6): Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W measured by rSBA(D91)
- Participants 3 through 5 MoA (Cohort III -Groups 5 and 6): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA(at 12 and 18 MoA (up to Day 484))
- Participants 3 through 5 MoA (Cohort III -Groups 5 and 6): Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W, measured by rSBA(at 12 and 18 MoA (up to Day 484))
- Participants 3 through 5 MoA (Cohort III -Groups 5 and 6): Antibody titers (in terms of GMTs) against meningococcal serogroups A, C, Y, and W, measured by rSBA(30 days after 12 and 18 MoA (up to Day 514))
- Participants 3 through 5 MoA (Cohort III -Groups 5 and 6): Antibody titers ≥1:8 and ≥1:128 against meningococcal serogroups A, C, Y, and W, measured by rSBA(30 days after 12 and 18 MoA (up to Day 514))