A Phase I/II, Randomized, Descriptive, Safety and Immunogenicity Study to Assess Pentavalent Meningococcal ABCYW Vaccine Formulations in Adults (18 to 25 Years of Age) and Adolescents (10 to 17 Years of Age).
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1,215
- 试验地点
- 83
- 主要终点
- Number of participants with immediate adverse events (AEs)
研究概览
简要总结
The purpose of VAN00010 study is to assess the safety and immunogenicity of the investigational pentavalent meningococcal ABCYW vaccine in adults and adolescents.
The study duration will be up to 12 months for all participants.
详细描述
The study duration will be approximately 12 months for all participants
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Modified double-blind: in order to maintain the blind, a placebo injection will be given and blood sample will be collected from all participants at each visit
入排标准
- 年龄范围
- 10 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 25 years or 10 to 17 years on the day of inclusion
- •Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgment of the Investigator.
- •Participants who are either unvaccinated with MenACWY vaccine or have received a single previous dose of MenACWY vaccine at least 4 years prior to study enrollment
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Known or suspected congenital or acquired immunodeficiency
- •History of any Neisseria meningitidis infection
- •At high risk for meningococcal infection during the study
- •Individuals with active tuberculosis
- •History of Guillain-Barré syndrome
- •Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion NOTE: 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: MenPenta Formulation 1
Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo
干预措施: Pentavalent Meningococcal ABCYW vaccine (Biological)
Group 1: MenPenta Formulation 1
Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo
干预措施: Placebo (Biological)
Group 2: MenPenta Formulation 2
Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo
干预措施: Pentavalent Meningococcal ABCYW vaccine (Biological)
Group 2: MenPenta Formulation 2
Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo
干预措施: Placebo (Biological)
Group 3: Bexsero® + Menveo®
Participants (ACWY naive and primed adults or adolescents) will receive injections of Bexsero® + Menveo® vaccine
干预措施: Meningococcal group B vaccine (Biological)
Group 3: Bexsero® + Menveo®
Participants (ACWY naive and primed adults or adolescents) will receive injections of Bexsero® + Menveo® vaccine
干预措施: MenACYW conjugate vaccine (Biological)
Group 4: Trumenba® + Menveo®
Participants (ACWY naive and primed adults or adolescents) will receive injections of Trumenba® + Menveo® vaccine
干预措施: Meningococcal group B vaccine (Biological)
Group 4: Trumenba® + Menveo®
Participants (ACWY naive and primed adults or adolescents) will receive injections of Trumenba® + Menveo® vaccine
干预措施: MenACYW conjugate vaccine (Biological)
Group 5: MenQuadfi®
Participants (ACWY naive and primed adults or adolescents) will receive injections of MenQuadfi® vaccine and placebo
干预措施: MenACYW conjugate vaccine (Biological)
Group 5: MenQuadfi®
Participants (ACWY naive and primed adults or adolescents) will receive injections of MenQuadfi® vaccine and placebo
干预措施: Placebo (Biological)
Group 6: Sanofi MenB
Participants (ACWY naive and primed adults or adolescents) will receive injections of SP MenB vaccine and placebo
干预措施: Meningococcal group B vaccine (Biological)
Group 6: Sanofi MenB
Participants (ACWY naive and primed adults or adolescents) will receive injections of SP MenB vaccine and placebo
干预措施: Placebo (Biological)
Group 7: PENBRAYA
Participants (ACWY naive and primed adolescents) will receive injections of PENBRAYA vaccine and placebo
干预措施: MenABCYW conjugate vaccine (Biological)
结局指标
主要结局
Number of participants with immediate adverse events (AEs)
时间窗: Within 30 minutes after each vaccination
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Number of participants with out-of-range biological test results
时间窗: Before each vaccination up to 7 days after primary vaccination visits in the sentinel cohorts (the first 5 participants enrolled in each vaccine group) of each age group
Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 pre-dose 1 and 1 month post-second dose in adolescent participants
时间窗: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
hSBA titers ≥ 1:8 for reference MenB strains
Number of participants with solicited injection site reactions or systemic reactions
时间窗: Within 7 days after each vaccination
Pre-defined solicited injection site reactions and systemic reactions that are pre-listed in the diary cards and CRF
Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each of serogroups A, C, W, and Y in adolescent participants
时间窗: Day 01 (pre-dose) Day 211 (for Group 1 to 7)
Number of participants with unsolicited AEs
时间窗: Within 30 days after each vaccination
Non-serious AEs other than solicited reactions
Number of participants with serious adverse events (SAEs)
时间窗: From baseline up to 12 months
SAEs (including adverse events of special interest \[AESIs\]) reported throughout the study
hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 1 month after the second dose in adolescent participants
时间窗: Day 211 (for Group 1 to 7)
hSBA titers ≥ 1:8
hSBA meningococcal serogroup B seroresponse pre-dose and 1 month after second dose in adolescent participants
时间窗: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
Seroresponse defined as a 4-fold increase in hSBA titers
Number of participants with medically attended adverse events (MAAEs)
时间窗: From baseline up to 12 months
An MAAE is a new onset or a worsening of a condition that prompts the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or Emergency Department
hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse pre-dose and 1 month after the second dose in adolescent participants
时间窗: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
Seroresponse defined as post-second vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers \< 1:4 or post-second vaccination titers ≥ 4 times the pre-vaccination titer for participants with a pre-vaccination titer more than or equal to the lower limit of quantification (LLOQ)
Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the second dose in adolescent participants
时间窗: Day 01 (pre-dose) and Day 31 Day 211 (for Group 1 to 7)
Geometric mean titers
Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 pre-dose 1 and 1 month post-second dose in adolescent participants
时间窗: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
hSBA titers ≥ 1:4 for reference MenB strains
Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose 1 and 1 month post-second dose in adolescent participants
时间窗: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
Geometric mean titers for the reference MenB strains
Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all serogroups B (reference MenB strains) in adolescent participants
时间窗: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)
次要结局
- hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse at each timepoint(D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7))
- hSBA meningococcal serogroups A, C, W, and Y antibody titers at each timepoint(D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7))
- Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ for reference MenB strains for each timepoint(D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7))
- hSBA meningococcal serogroup B (reference and additional MenB strains) vaccine seroresponse pre-dose 1 and 1 month post-second and third dose in adolescent participants(Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents))
- Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference and additional MenB strains) ≥ 1:4 pre-dose 1 and 1 month post-second and third dose in adolescent participants(Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents))
- hSBA meningococcal serogroup B (reference MenB strains) vaccine seroresponse at each timepoint(D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7))
- Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 at each timepoint(D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7))
- Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y at each timepoint(D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7))
- Percentage of participants with hSBA titers more or equal to LLOQ against each of serogroups A, C, W, and Y at each timepoint(D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7))
- Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 at each timepoint(D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7))
- Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) at each timepoint(D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7))
- Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference and additional MenB strains) ≥ 1:8 pre-dose 1 and 1 month post-second and third dose in adolescent participants(Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents))
- Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference and additional MenB strains) pre-dose 1 and 1 month post-second and third dose in adolescent participants(Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents))
- Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ reference and additional MenB strains in adolescent participants(Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents))
- hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse 1 month after the third dose in adult participants(Day 01 (pre-dose) and Day 211 (for Group 1 to 6))
- hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 1 month after the third dose in adult participants(Day 01 (pre-dose) and Day 211 (for Group 1 to 6))
- Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the third dose in adult participants(Day 01 (pre-dose) and Day 211 (for Group 1 to 6))
- Percentage of participants with hSBA titers more or equal to LLOQ against each of serogroups A, C, W, and Y in adult participants(Day 01 (pre-dose) and Day 211 (for Group 1 to 6))
- hSBA meningococcal serogroup B (reference MenB strains) seroresponse pre-dose and 1 month after third dose in adult participants(Day 01 (pre-dose) and Day 211 (for Group 1 to 6))
- Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 pre-dose 1 and 1 month post-third dose in adult participants(Day 01 (pre-dose) and Day 211 (for Group 1 to 6))
- Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 pre-dose 1 and 1 month post-third dose in adult participants(Day 01 (pre-dose) and Day 211 (for Group 1 to 6))
- Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose 1 and 1 month post-third dose in adult participants(Day 01 (pre-dose) and Day 211 (for Group 1 to 6))
- Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all serogroups B (reference MenB strains) in adult participants(Day 01 (pre-dose) and Day 211 (for Group 1 to 6))