A Parallel-group Prevention, Phase II, Partially Blinded, Multi-stage Study to Investigate the Immunogenicity and Safety of Pentavalent Meningococcal ABCYW Vaccine Formulations Compared With Licensed Meningococcal Vaccines When Administered Alone in Healthy Children (2 to 9 Years of Age) or Concomitantly With Routine Pediatric Vaccines in Toddlers (12 to 15 Months of Age) and Infants (2 Months of Age).
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 750
- 试验地点
- 39
- 主要终点
- Number of participants with unsolicited immediate adverse events (AEs)
研究概览
简要总结
This study is the first study of Sanofi's Pentavalent Meningococcal ABCYW vaccine clinical development program to be conducted in the pediatric population below 10 years of age. The aim of the study is to assess 2 formulations of the MenPenta vaccine compared to licensed meningococcal vaccines when administered alone in children (Stage 1) or concomitantly with routine pediatric vaccines in toddlers (Stage 2) and infants (Stage 3).
Study details include:
The study duration per participant will be up to 12 months for children in Stage 1 and toddlers in Stage 2 and 16 to-19 months for infants in Stage 3.
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
Partially blinded (treatment assignment is blinded between the two investigational formulation groups, and open label between the investigation and the comparator group)
- Laboratory personnel will be blinded to the treatment assignment
- Participants, Investigators, and Site staff preparing and administering the study intervention will be unblinded between the MenPenta and comparator groups but will be blinded between the 2 MenPenta groups The Sponsor will be partially blinded. At the time of periodic data reviews, additional measures are put in place to maintain the blind of the study participants for the Sponsor staff. The data review will be conducted on the basis of blinded outputs (where data of the 2 MenPenta groups and the control group will be reviewed in aggregate, without any distinction by group). By design, the Sponsor team will have access to partially blinded data for individual participants (eg, for assessment of SAE)
入排标准
- 年龄范围
- 56 Days 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 2 to 9 years (Stage 1) or 12 to 15 months (Stage 2) or 56 to 89 days (Stage 3) on the day of inclusion
- •For infants and toddlers, born at full term of pregnancy (≥37 weeks) and with a birth weight ≥ 2.5 Kg or born after a gestation period of period above 28 (> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 Kg and in both cases medically stable as assessed by the investigator, based on the following definition: "Medically stable" refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention
- •Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgement of the investigator
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, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months or since birth for infants; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months or since birth for and infants)
- •History of any meningitis infection, confirmed either clinically, serologically, or microbiologically
- •At high risk of 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
- •Individual with active tuberculosis
- •History of Guillain-Barré syndrome
- •For Stage 3 infants: History of intussusception
- •Previous vaccination against meningococcal serogroups A, B, C, W, and/or Y with an investigational or marketed vaccine
- •For Stage 3 infants: receipt of the first dose of rotavirus vaccine less than 28 days before the first trial vaccination
- •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
Stage 1: MenPenta vaccine formulation 1
MenPenta vaccine formulation 1, children 2-9 years of age
干预措施: Pentavalent Meningococcal ABCYW vaccine (Biological)
Stage 1: MenPenta vaccine formulation 2
MenPenta vaccine formulation 2, children 2-9 years of age
干预措施: Pentavalent Meningococcal ABCYW vaccine (Biological)
Stage 1: vaccine comparator(s)
Comparator vaccines: Bexsero + MenQuadfi, children 2-9 years of age
干预措施: MenACYW conjugate vaccine (Biological)
Stage 1: vaccine comparator(s)
Comparator vaccines: Bexsero + MenQuadfi, children 2-9 years of age
干预措施: Meningococcal group B vaccine (Biological)
Stage 2: MenPenta vaccine formulation 1
MenPenta vaccine formulation 1 + routine vaccines, toddlers 12-15 months of age
干预措施: Pentavalent Meningococcal ABCYW vaccine (Biological)
Stage 2: MenPenta vaccine formulation 1
MenPenta vaccine formulation 1 + routine vaccines, toddlers 12-15 months of age
干预措施: Paracetamol (Drug)
Stage 2: MenPenta vaccine formulation 1
MenPenta vaccine formulation 1 + routine vaccines, toddlers 12-15 months of age
干预措施: DTap-HepB-IPV-Hib vaccine (Biological)
Stage 2: MenPenta vaccine formulation 1
MenPenta vaccine formulation 1 + routine vaccines, toddlers 12-15 months of age
干预措施: Pneumococcal 13-valent conjugate vaccine (Biological)
Stage 2: MenPenta vaccine formulation 2
MenPenta vaccine formulation 2 + routine vaccines, toddlers 12-15 months of age
干预措施: Pentavalent Meningococcal ABCYW vaccine (Biological)
Stage 2: MenPenta vaccine formulation 2
MenPenta vaccine formulation 2 + routine vaccines, toddlers 12-15 months of age
干预措施: Paracetamol (Drug)
Stage 2: MenPenta vaccine formulation 2
MenPenta vaccine formulation 2 + routine vaccines, toddlers 12-15 months of age
干预措施: DTap-HepB-IPV-Hib vaccine (Biological)
Stage 2: MenPenta vaccine formulation 2
MenPenta vaccine formulation 2 + routine vaccines, toddlers 12-15 months of age
干预措施: Pneumococcal 13-valent conjugate vaccine (Biological)
Stage 2: vaccine comparator(s)
Comparator vaccines: Bexsero + MenQuadfi + routine vaccines, toddlers 12-15 months of age
干预措施: MenACYW conjugate vaccine (Biological)
Stage 2: vaccine comparator(s)
Comparator vaccines: Bexsero + MenQuadfi + routine vaccines, toddlers 12-15 months of age
干预措施: Meningococcal group B vaccine (Biological)
Stage 2: vaccine comparator(s)
Comparator vaccines: Bexsero + MenQuadfi + routine vaccines, toddlers 12-15 months of age
干预措施: Paracetamol (Drug)
Stage 2: vaccine comparator(s)
Comparator vaccines: Bexsero + MenQuadfi + routine vaccines, toddlers 12-15 months of age
干预措施: DTap-HepB-IPV-Hib vaccine (Biological)
Stage 2: vaccine comparator(s)
Comparator vaccines: Bexsero + MenQuadfi + routine vaccines, toddlers 12-15 months of age
干预措施: Pneumococcal 13-valent conjugate vaccine (Biological)
Stage 3: MenPenta vaccine formulation 1
MenPenta vaccine formulation 1 + routine vaccines, infants approximately 2 months of age
干预措施: Pentavalent Meningococcal ABCYW vaccine (Biological)
Stage 3: MenPenta vaccine formulation 1
MenPenta vaccine formulation 1 + routine vaccines, infants approximately 2 months of age
干预措施: Paracetamol (Drug)
Stage 3: MenPenta vaccine formulation 1
MenPenta vaccine formulation 1 + routine vaccines, infants approximately 2 months of age
干预措施: DTap-HepB-IPV-Hib vaccine (Biological)
Stage 3: MenPenta vaccine formulation 1
MenPenta vaccine formulation 1 + routine vaccines, infants approximately 2 months of age
干预措施: Rotavirus vaccine (Biological)
Stage 3: MenPenta vaccine formulation 1
MenPenta vaccine formulation 1 + routine vaccines, infants approximately 2 months of age
干预措施: Pneumococcal 13-valent conjugate vaccine (Biological)
Stage 3: MenPenta vaccine formulation 2
MenPenta vaccine formulation 2 + routine vaccines, infants approximately 2 months of age
干预措施: Pentavalent Meningococcal ABCYW vaccine (Biological)
Stage 3: MenPenta vaccine formulation 2
MenPenta vaccine formulation 2 + routine vaccines, infants approximately 2 months of age
干预措施: Paracetamol (Drug)
Stage 3: MenPenta vaccine formulation 2
MenPenta vaccine formulation 2 + routine vaccines, infants approximately 2 months of age
干预措施: DTap-HepB-IPV-Hib vaccine (Biological)
Stage 3: MenPenta vaccine formulation 2
MenPenta vaccine formulation 2 + routine vaccines, infants approximately 2 months of age
干预措施: Rotavirus vaccine (Biological)
Stage 3: MenPenta vaccine formulation 2
MenPenta vaccine formulation 2 + routine vaccines, infants approximately 2 months of age
干预措施: Pneumococcal 13-valent conjugate vaccine (Biological)
Stage 3: vaccine comparator(s)
Comparator vaccines: Bexsero + Nimenrix + routine vaccines, infants approximately 2 months of age
干预措施: MenACYW conjugate vaccine (Biological)
Stage 3: vaccine comparator(s)
Comparator vaccines: Bexsero + Nimenrix + routine vaccines, infants approximately 2 months of age
干预措施: Meningococcal group B vaccine (Biological)
Stage 3: vaccine comparator(s)
Comparator vaccines: Bexsero + Nimenrix + routine vaccines, infants approximately 2 months of age
干预措施: Paracetamol (Drug)
Stage 3: vaccine comparator(s)
Comparator vaccines: Bexsero + Nimenrix + routine vaccines, infants approximately 2 months of age
干预措施: DTap-HepB-IPV-Hib vaccine (Biological)
Stage 3: vaccine comparator(s)
Comparator vaccines: Bexsero + Nimenrix + routine vaccines, infants approximately 2 months of age
干预措施: Rotavirus vaccine (Biological)
Stage 3: vaccine comparator(s)
Comparator vaccines: Bexsero + Nimenrix + routine vaccines, infants approximately 2 months of age
干预措施: Pneumococcal 13-valent conjugate vaccine (Biological)
结局指标
主要结局
Number of participants with unsolicited 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 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
Number of participants with unsolicited AEs
时间窗: Within 30 days after each vaccination
Unsolicited AEs other than solicited reactions
Number of participants with serious adverse events (SAEs)
时间窗: Throughout the study, from first visit until 180 days after the last vaccination
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 30 days after the second and third dose in infant participants
时间窗: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
hSBA titers ≥ 1:8 post-vaccination (post-second and third dose)
Percentage of participants with hSBA titers less than the lower limit of quantification (LLOQ) against all serogroup B (reference MenB strains) in children and toddlers
时间窗: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse pre-dose and 1 month after the second and third dose in infant participants
时间窗: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
Seroresponse defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers \< 1:4 or or postvaccination titers ≥ 4 times the lower limit of quantification (LLOQ) for participants with a pre-vaccination titer ≤ LLOQ or a post-vaccination titer ≥ 4 times the pre-vaccination titer for participants with a pre-vaccination titer ≥ LLOQ
Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the second and third dose in infant participants
时间窗: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
Geometric mean titers (pre-dose and post-second and third dose)
Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each of serogroups A, C, W, and Y pre-dose and 1 month after the second and third dose in infant participants
时间窗: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 pre-dose and 1 month after second dose of vaccination against serogroup B, before and 30 days after third dose in infants
时间窗: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
hSBA titers ≥ 1:4 for reference MenB strains
Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 pre-dose and 1 month after the second dose of vaccination against serogroup B, before and 30 days after third dose in infants
时间窗: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
hSBA titers ≥ 1:8 for reference MenB strains
hSBA meningococcal serogroup B seroresponse pre-dose and 1 month after the second dose of vaccination against serogroup B, before and 30 days after third dose in infant participants
时间窗: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
Seroresponse defined as a 4-fold increase in hSBA titers
Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose and 1 month after the second dose of vaccination against serogroup B, before and 30 days after third dose in infant participants
时间窗: Day 01, Day 91, Day 181 and Day 211 (for Stage 3)
Geometric mean titers (pre-dose and post-second dose) for the reference MenB strains
Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all of serogroup B (ref. MenB strains) predose and 1 month after 2nd dose against serogroup B, before and 30 days after 3rd dose in infants
时间窗: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
Percentage of participants with hSBA titers less than LLOQ against all serogroup B (ref. MenB strains) pre-dose and 1 month after the 2nd dose of vaccination against serogroup B, before and 30 days after 3rd dose in infants
时间窗: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
hSBA meningococcal serogroups A, C, W, and Y antibody titers in children and toddlers
时间窗: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
hSBA titers ≥ 1:8 for serogroups A, C, W, and Y
hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse in children and toddlers
时间窗: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
Seroresponse defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers \< 1:4 or or postvaccination titers ≥ 4 times the lower limit of quantification (LLOQ) for participants with a pre-vaccination titer ≤ LLOQ or a post-vaccination titer ≥ 4 times the pre-vaccination titer for participants with a pre-vaccination titer ≥ LLOQ
Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the second dose children and toddlers
时间窗: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each of serogroups A, C, W, and Y children and toddlers
时间窗: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 in children and toddlers
时间窗: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 in children and toddlers
时间窗: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
hSBA meningococcal serogroup B (reference MenB strains) vaccine seroresponse in children and toddlers
时间窗: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
Seroresponse defined as a 4-fold increase in hSBA titers
Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) in children and toddlers
时间窗: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all of serogroup B (reference MenB strains) in children and toddlers
时间窗: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
次要结局
- hSBA meningococcal serogroup B (additional MenB strains) vaccine seroresponse in children, toddler and infant participants(Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391)
- Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (additional MenB strains) ≥ 1:4 in children, toddler and infant participants(Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391)
- Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (additional MenB strains) ≥ 1:8 in children, toddler and infant participants(Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391)
- Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (additional MenB strains) in children, toddler and infant participants(Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391)
- Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ each and all additional MenB strains in children, toddler and infant participants(Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391)
- Percentage of participants with hSBA composite seroresponse titers less than LLOQ all additional MenB strains in children, toddler and infant participants(Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391)