A Phase III, Partially Modified Double-blind, Randomized, Parallel-group, Active-controlled, Multi-center Study to Compare the Immunogenicity and Describe the Safety of MenACYW Conjugate Vaccine and MENVEO® When Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in the United States
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,627
- 试验地点
- 70
- 主要终点
- Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination
研究概览
简要总结
The purpose of this study was to compare the immunogenicity and describe the safety of MenACYW conjugate vaccine and MENVEO® when both are administered concomitantly with routine pediatric vaccines to healthy infants and toddlers in the US.
详细描述
The duration of each subject's participation in the trial was approximately 16 to 19 months (Subgroup 1a) and 19 to 22 months (Subgroup 1b and Group 2), which included a safety follow up contact at 6 months after the last vaccinations.
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
The study was conducted modified double blind for the infant part of the study, with everyone involved in the study (participants/parents, investigators, safety outcome assessor, Sponsor) blinded to the meningococcal vaccine received, except the personnel administering the vaccine.
入排标准
- 年龄范围
- 42 Days 至 89 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥ 42 to ≤ 89 days on the day of the first study visit.
- •Healthy infants as determined by medical history, physical examination, and judgment of the investigator
- •Informed consent form has been signed and dated by the parent(s) or guardian, and an independent witness, if required by local regulations
- •Participant and parent/guardian were able to attend all scheduled visits and to comply with all trial procedures.
- •Infants who received the first dose of hepatitis B vaccine at least 28 days before the first study visit
排除标准
- •Participation at the time of study enrollment or in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- •Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks before and/or following any trial vaccination except for influenza vaccination, which could have been received at a gap of at least 2 weeks before or 2 weeks after any study vaccination. This exception included monovalent pandemic influenza vaccines and multivalent influenza vaccines
- •Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, PS, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine).
- •Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis A, measles, mumps, rubella, varicella; and of Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection or disease
- •Receipt of more than 1 previous dose of hepatitis B vaccine
- •Receipt of immune globulins, blood, or blood-derived products since birth
- •Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth
- •Family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated
- •Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
- •Individuals with active tuberculosis
- •History of any Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically
- •History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, hepatitis A, measles, mumps, rubella, varicella; and of Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection or disease
- •At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease)
- •History of intussusception
- •History of any neurologic disorders, including any seizures and progressive neurologic disorders
- •History of Guillain-Barré syndrome
- •Known systemic hypersensitivity to any of the vaccine components or to latex, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances, including neomycin, gelatin, and yeast
- •Verbal report of thrombocytopenia contraindicating intramuscular vaccination in the investigator's opinion
- •Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the investigator's opinion
- •Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
- •Chronic illness (including, but not limited to, cardiac disorders, congenital heart disease, chronic lung disease, renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and known congenital or genetic diseases) that in the opinion of the investigator, was at a stage where it might have interfered with trial conduct or completion
- •Any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives
- •Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]). A prospective participant was not included in the study until the condition has been resolved or the febrile event has been subsided
- •Identified as a natural or adopted child of the investigator or employee with direct involvement in the proposed study
- •The above information was 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 1a
MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age
干预措施: MenACYW conjugate vaccine (Biological)
Group 1a
MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age
干预措施: DTaP-IPV//Hib vaccine (Biological)
Group 1a
MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age
干预措施: Pneumococcal 13-valent conjugate vaccine (Biological)
Group 1a
MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age
干预措施: Pentavalent rotavirus vaccine (Biological)
Group 1a
MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age
干预措施: Hepatitis B vaccine (Biological)
Group 1a
MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age
干预措施: Measles, mumps, rubella (MMR) vaccine (Biological)
Group 1a
MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age
干预措施: Varicella vaccine (Biological)
Group 1b
MenACYW conjugate vaccine at 2, 4, 6, and 15 to 18 months of age and routine vaccines at 2, 4, 6, 12 to 15 months of age, and 15 to 18 months of age
干预措施: MenACYW conjugate vaccine (Biological)
Group 1b
MenACYW conjugate vaccine at 2, 4, 6, and 15 to 18 months of age and routine vaccines at 2, 4, 6, 12 to 15 months of age, and 15 to 18 months of age
干预措施: DTaP-IPV//Hib vaccine (Biological)
Group 1b
MenACYW conjugate vaccine at 2, 4, 6, and 15 to 18 months of age and routine vaccines at 2, 4, 6, 12 to 15 months of age, and 15 to 18 months of age
干预措施: Pneumococcal 13-valent conjugate vaccine (Biological)
Group 1b
MenACYW conjugate vaccine at 2, 4, 6, and 15 to 18 months of age and routine vaccines at 2, 4, 6, 12 to 15 months of age, and 15 to 18 months of age
干预措施: Pentavalent rotavirus vaccine (Biological)
Group 1b
MenACYW conjugate vaccine at 2, 4, 6, and 15 to 18 months of age and routine vaccines at 2, 4, 6, 12 to 15 months of age, and 15 to 18 months of age
干预措施: Hepatitis B vaccine (Biological)
Group 1b
MenACYW conjugate vaccine at 2, 4, 6, and 15 to 18 months of age and routine vaccines at 2, 4, 6, 12 to 15 months of age, and 15 to 18 months of age
干预措施: Measles, mumps, rubella (MMR) vaccine (Biological)
Group 1b
MenACYW conjugate vaccine at 2, 4, 6, and 15 to 18 months of age and routine vaccines at 2, 4, 6, 12 to 15 months of age, and 15 to 18 months of age
干预措施: Varicella vaccine (Biological)
Group 1b
MenACYW conjugate vaccine at 2, 4, 6, and 15 to 18 months of age and routine vaccines at 2, 4, 6, 12 to 15 months of age, and 15 to 18 months of age
干预措施: Hepatitis A vaccine (Biological)
Group 2a
MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age
干预措施: MenACYW-135 conjugate vaccine (Biological)
Group 2a
MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age
干预措施: DTaP-IPV//Hib vaccine (Biological)
Group 2a
MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age
干预措施: Pneumococcal 13-valent conjugate vaccine (Biological)
Group 2a
MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age
干预措施: Pentavalent rotavirus vaccine (Biological)
Group 2a
MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age
干预措施: Hepatitis B vaccine (Biological)
Group 2a
MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age
干预措施: Measles, mumps, rubella (MMR) vaccine (Biological)
Group 2a
MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age
干预措施: Varicella vaccine (Biological)
Group 2b
MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age
干预措施: MenACYW-135 conjugate vaccine (Biological)
Group 2b
MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age
干预措施: DTaP-IPV//Hib vaccine (Biological)
Group 2b
MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age
干预措施: Pneumococcal 13-valent conjugate vaccine (Biological)
Group 2b
MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age
干预措施: Pentavalent rotavirus vaccine (Biological)
Group 2b
MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age
干预措施: Hepatitis B vaccine (Biological)
Group 2b
MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age
干预措施: Measles, mumps, rubella (MMR) vaccine (Biological)
Group 2b
MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age
干预措施: Varicella vaccine (Biological)
Group 2b
MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age
干预措施: Hepatitis A vaccine (Biological)
结局指标
主要结局
Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination
时间窗: Day 30 post 12-month vaccination (Month 13)
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Vaccine seroresponse was defined as a post 4th dose (Day 30 after 12-month) hSBA titer \>=1:16 for participants with pre 1st dose (Day 0 before 2-month) hSBA titer less than (\<) 1:8, or at least a 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8. Percentages are rounded off to the tenth decimal place.
Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 by hSBA at Day 30 Post 6-Month Vaccination
时间窗: Day 30 post 6-month vaccination (Month 7)
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place.
次要结局
- Groups 1 and 2: Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 Milli-International Units Per Milliliter (mIU/mL) at Day 30 Post 6-Month Vaccination(Day 30 post 6-month vaccination (Month 7))
- Groups 1 and 2: Percentage of Participants Who Achieved Anti-Polyribosyl-Ribitol (PRP) Antibody Concentrations >=0.15 and >=1.0 Microgram (mcg)/mL at Day 30 Post 6-Month Vaccination(Day 30 post 6-month vaccination (Month 7))
- Groups 1 and 2: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 6-Month Vaccination(Day 30 post 6-month vaccination (Month 7))
- Groups 1 and 2: Percentage of Participants Who Achieved Anti-Rotavirus Immunoglobulin A (IgA) Antibody Concentrations >=3-Fold Rise at Day 30 Post 6-Month Vaccination(Day 30 post 6-month vaccination (Month 7))
- Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Anti-Rotavirus IgA Antibodies at Day 30 Post 6-Month Vaccination(Day 30 post 6-month vaccination (Month 7))
- Groups 1 and 2: GMCs of Anti-Pertussis Antibodies at Day 30 Post 6-Month Vaccination(Day 30 post 6-month vaccination (Month 7))
- Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination(Day 30 post 6-month vaccination (Month 7))
- Groups 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies at Day 30 Post 12-Month Vaccination(Day 30 post 12-month vaccination (Month 13))
- Groups 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Varicella Antibodies at Day 30 Post 12-Month Vaccination(Day 30 post 12-month vaccination (Month 13))
- Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination(Day 30 post 12-month vaccination (Month 13))
- Groups 1b and 2b: Percentage of Participants Who Achieved Anti-PRP Antibody Concentrations >=1.0 mcg/mL at Day 30 Post 15-Month Vaccination(Day 30 post 15-month vaccination (Month 16))
- Groups 1b and 2b: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 15-Month Vaccination(Day 30 post 15-month vaccination (Month 16))
- Groups 1b and 2b: Percentage of Participants Who Achieved Vaccine Response for Anti-Pertussis Antibodies at Day 30 Post 15-Month Vaccination(Day 30 post 15-month vaccination (Month 16))
- Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination(Day 30 post 6-month vaccination (Month 7) and Day 0 before 12-month vaccination (Month 12))
- Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination(Day 30 post 6-month vaccination (Month 7) and Day 0 before 12-month vaccination (Month 12))