Safety and Immunogenicity of an Investigational Multicomponent Meningococcal Group B Vaccine in Adults, Adolescents, Toddlers, and Infants
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 576
- 试验地点
- 10
- 主要终点
- Number of participants with immediate adverse events (AEs)
研究概览
简要总结
Primary Objective:
- To describe the safety profile of the SP MenB vaccine formulations and the 2 licensed MenB comparator vaccines in healthy adults, adolescents, toddlers and infants, when administered alone (Stages 1-4) or concomitantly with MenQuadfiTM (MenACYW conjugate vaccine) (for Stages 2-4 only), and with age-appropriated routine pediatric vaccines (for Stages 3-4 only)
- To describe the safety profile of the SP MenB vaccine formulations, Bexsero Vaccine and Trumenba Vaccine in healthy adults, and adolescents;
- To describe the safety profile of the SP MenB vaccine formulations and Bexsero Vaccine in toddlers and infants;
- To describe the safety profile of the SP MenB vaccine formulations,
- when administered alone
- when administered with MenQuadfiTM (MenACYW conjugate vaccine)
- when administered with routine infant immunizations
- To describe the immune response to the SP MenB vaccine formulations and the 2 licensed MenB comparator vaccines after the last dose of primary vaccination in healthy adults, adolescents, toddlers and infants, when administered alone, or concomitantly with MenQuadfi Vaccine or other routine vaccines, as measured by the serum bactericidal assay using human complement (hSBA) in the primary panel of MenB strains by Stage, by age group and by vaccine schedule
Secondary Objective:
- To describe the immune response to the SP MenB vaccine formulations and the 2 licensed MenB comparator vaccines at each timepoint in healthy adults, adolescents, toddlers and infants, when administered alone or concomitantly with MenQuadfi Vaccine or other routine vaccines as measured by hSBA in the primary panel of MenB strains by Stage by age group and by vaccine schedule
- To describe the immune response (breadth of coverage) in the secondary panel of MenB strains in participants (adults and adolescents) in Stage 1 and 2 after the last dose of the primary series in each group
- To describe the persistence of immune response following primary series at D366, and immune response 1 month after a booster dose of the SP MenB vaccine given 1-year post-dose 1 (at D366) in a subset of adults and adolescents in Stage 2 who received SP MenB vaccine formulations, Bexsero Vaccine or Trumenba Vaccine as measured by hSBA in the primary panel of MenB strains by age group
- To describe the immune response against meningococcal serogroups A, C, W and Y measured with hSBA in participants from each agegroup receiving MenQuadfi Vaccine
详细描述
Study duration per participant will be approximately: 7 months for Stage 1 participants, 12 to 18.5 months for Stage 2 participants, 12 months for Stage 3 participants and 18 months for Stage 4 participants
In each vaccine group at each age group (Stage 1, 3 and 4 only), the first 5 participants enrolled (sentinels) will be assessed via early safety data review (ESDR) as a cohort for the evaluation of biological safety and overall safety profile for D01-D08 post dose 1. The safety data collected will be reviewed before proceeding with recruitment of remaining participants in each study group. Enrollment of remaining participants randomized to each group will be based on the outcome of the safety assessments of the sentinels: only a positive review outcome will allow the enrollment of the sentinel cohort of the respective lower age group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Stage 1 and Stage 2 (adults and adolescents) will be modified double-blind: the investigators and study staff who conduct the safety assessment and the participant will not know which vaccine is administered. Only the study staff who prepare and administer the vaccine and are not involved with the safety evaluation will know which vaccine is administered. The individual(s) responsible for the preparation / administration of the vaccines will not be authorized to collect any safety or serology data. Testing laboratories will be blinded. In order to maintain the blind in Stage 2 (adults and adolescents), a placebo injection will be used. After the 6-months safety assessment from the last dose of primary vaccination, Stage 2 will be unblinded for the administration of booster vaccinations. Stage 3 and Stage 4 (toddlers and infants) will be open-label.
入排标准
- 年龄范围
- 42 Days 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Stage 1: MenB vaccine formulation(s)
Assigned MenB vaccine formulation or Placebo single injection in the respective dosing schedule at Day 01, Day 31 and Day 181
干预措施: Meningococcal Group B Vaccine MenB (Drug)
Stage 2: vaccine comparator(s)
Bexsero vaccine or Trumenba vaccine and Placebo single injection in the respective dosing schedule at Day 01, Day 31, Day 61 and Day 181 + booster dose of Bexsero vaccine single injection at Day 366
干预措施: Placebo (Drug)
Stage 1: MenB vaccine formulation(s)
Assigned MenB vaccine formulation or Placebo single injection in the respective dosing schedule at Day 01, Day 31 and Day 181
干预措施: Placebo (Drug)
Stage 1: vaccine comparator(s)
Bexsero vaccine or Trumenba vaccine or Placebo single injection in the respective dosing schedule at Day 01, Day 31 and Day 181
干预措施: Multicomponent Meningococcal B Vaccine (Drug)
Stage 1: vaccine comparator(s)
Bexsero vaccine or Trumenba vaccine or Placebo single injection in the respective dosing schedule at Day 01, Day 31 and Day 181
干预措施: Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed) (Drug)
Stage 1: vaccine comparator(s)
Bexsero vaccine or Trumenba vaccine or Placebo single injection in the respective dosing schedule at Day 01, Day 31 and Day 181
干预措施: Placebo (Drug)
Stage 2: MenB vaccine formulation(s)
Assigned MenB vaccine formulation, MenQuadfi vaccine and Placebo single injection in the respective dosing schedule at Day 01, Day 31, Day 61 and Day 181 + booster dose of leading MenB vaccine formulation single injection at Day 366
干预措施: Meningococcal Group B Vaccine MenB (Drug)
Stage 2: MenB vaccine formulation(s)
Assigned MenB vaccine formulation, MenQuadfi vaccine and Placebo single injection in the respective dosing schedule at Day 01, Day 31, Day 61 and Day 181 + booster dose of leading MenB vaccine formulation single injection at Day 366
干预措施: Placebo (Drug)
Stage 2: MenB vaccine formulation(s)
Assigned MenB vaccine formulation, MenQuadfi vaccine and Placebo single injection in the respective dosing schedule at Day 01, Day 31, Day 61 and Day 181 + booster dose of leading MenB vaccine formulation single injection at Day 366
干预措施: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine (Drug)
Stage 2: vaccine comparator(s)
Bexsero vaccine or Trumenba vaccine and Placebo single injection in the respective dosing schedule at Day 01, Day 31, Day 61 and Day 181 + booster dose of Bexsero vaccine single injection at Day 366
干预措施: Multicomponent Meningococcal B Vaccine (Drug)
Stage 2: vaccine comparator(s)
Bexsero vaccine or Trumenba vaccine and Placebo single injection in the respective dosing schedule at Day 01, Day 31, Day 61 and Day 181 + booster dose of Bexsero vaccine single injection at Day 366
干预措施: Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed) (Drug)
Stage 3: Men B vaccine formulation(s)
Assigned MenB vaccine formulation and/or MenQuadfi vaccine single injection in the respective dosing schedule at Day 01 and Day 61
干预措施: Meningococcal Group B Vaccine MenB (Drug)
Stage 3: Men B vaccine formulation(s)
Assigned MenB vaccine formulation and/or MenQuadfi vaccine single injection in the respective dosing schedule at Day 01 and Day 61
干预措施: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine (Drug)
Stage 3: MenQuadfi vaccine and vaccine comparator
MenQuadfi vaccine single injection at Day 01 or Bexsero vaccine single injection at Day 01 and Day 61
干预措施: Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed) (Drug)
Stage 3: MenQuadfi vaccine and vaccine comparator
MenQuadfi vaccine single injection at Day 01 or Bexsero vaccine single injection at Day 01 and Day 61
干预措施: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine (Drug)
Stage 4: MenB vaccine formulation(s)
Assigned MenB vaccine formulation, Routine Vaccines (RV)s and MenQuadfi vaccine single injection in the respective dosing at 2 months of ages [moa] (Day 01), 4moa (Day 61) and 12 moa
干预措施: Meningococcal Group B Vaccine MenB (Drug)
Stage 4: MenB vaccine formulation(s)
Assigned MenB vaccine formulation, Routine Vaccines (RV)s and MenQuadfi vaccine single injection in the respective dosing at 2 months of ages [moa] (Day 01), 4moa (Day 61) and 12 moa
干预措施: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine (Drug)
Stage 4: MenQuadfi vaccine and vaccine comparator
MenQuadfi vaccine or Bexsero vaccine and RVs in the respective dosing schedule at 2 months of ages [moa] (Day 01), 4moa (Day 61) and 12 moa
干预措施: Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed) (Drug)
Stage 4: MenQuadfi vaccine and vaccine comparator
MenQuadfi vaccine or Bexsero vaccine and RVs in the respective dosing schedule at 2 months of ages [moa] (Day 01), 4moa (Day 61) and 12 moa
干预措施: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine (Drug)
结局指标
主要结局
Number of participants with immediate adverse events (AEs)
时间窗: Within 30 minutes after vaccination
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Number of participants with unsolicited AEs
时间窗: Within 30 days after vaccination
AEs that do not fulfill the conditions of solicited reactions
Number of participants with serious adverse events (SAEs)
时间窗: Up to 6 months after last vaccination
SAEs reported throughout the study, including adverse events of special interest (AESI)s
Number of participants with medically attended adverse events (MAAE)s
时间窗: Up to 6 months after last vaccination
AEs with a new onset or a worsening of a condition that prompts the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or Emergency Department
Antibody titers in the primary panel of MenB strains after primary vaccination
时间窗: Day 30 (post-vaccination)
Antibody titers measured by hSBA
Number of participants with solicited injection site reactions or systemic reactions
时间窗: Within 7 days after vaccination
Adverse reactions pre-listed in the protocol and case report form (CRF) Injection site reactions: pain, erythema and swelling (or tenderness, erythema and swelling for infants and toddlers) Systemic reactions: fever, headache, malaise, myalgia (or fever, vomiting, crying abnormal, drowsiness, appetite lost, irritability for infants and toddlers)
Antibody titers in the primary panel of MenB strains before primary vaccination
时间窗: Day 01 (pre-vaccination)
Antibody titers measured by serum bactericidal assay using human complement (hSBA)
Number of participants with out-of-range biological test results
时间窗: From baseline (pre-vaccination) up to Day 07 (post-vaccination)
Out-of-range biological test results occurring in the sentinel cohorts of each age group
次要结局
- Antibody titers in the primary panel of MenB strains after each vaccination(Day 01, Day 31, Day 61, Day 91, Day 181, Day 211, Day 366 and Day 396)
- Antibody titers in the primary panel of MenB strains (stage 2 only)(Day 366 (pre-vaccination) and Day 396 (post-vaccination))
- Antibody titers against each of Men A, C, W, and Y strains(Day 01 (pre-vaccination) and Day 30 (post-vaccination))
- Antibody titers in the secondary panel of MenB strains (stage 1 and 2 only)(Day 01 (pre-vaccination) and Day 30 (post-vaccination))