Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,528
- 试验地点
- 15
- 主要终点
- Percentage of participants with anti-meningococcal serogroups A, C, Y, W antibody titers above predefined thresholds after 2 doses of MenACYW conjugate vaccine compared to 2 doses of Menactra® vaccine in infants and toddlers 6 months to 16 months of age
研究概览
简要总结
This open label randomized study will be conducted to evaluate and/or describe the immunogenicity and describe the safety of MenACYW conjugate vaccine when administered in infants and toddlers.
It will be conducted in India and the RSA in 2 cohorts:
- Cohort I: Infants and toddlers 6 months to 16 months of age (Cohort I)
- Cohort II: Infants and toddlers 6 weeks to 15 months of age (Cohort II) In Cohort I, eligible participants will be randomized in a 1:1 ratio to receive 2 intramuscular (IM) injections (1+1 vaccination schedule) of either MenACYW conjugate vaccine (Groups 1 and 3) or Menactra vaccine (Groups 2 and 4), co-administered with routine pediatric vaccines.
In Cohort II, eligible participants will be randomized in a 2:1 ratio to receive either 3 IM injections (2+1 vaccination schedule) of MenACYW conjugate vaccine co-administered with routine pediatric vaccines (Groups 5 and 7) or routine pediatric vaccines only (Groups 6 and 8).
The primary objectives of this study are:
- To demonstrate the non-inferiority of immunogenicity of 2 doses of MenACYW conjugate vaccine compared to 2 doses of Menactra® vaccine in infants and toddlers 6 months to 16 months of age (Cohort I) in terms of serum bactericidal assay using human complement (hSBA) seroprotection (titers ≥ 1:8) in India and the Republic of South Africa (RSA)
- To demonstrate the vaccine immune sufficiency of 3 doses of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age (Cohort II) in terms of hSBA seroprotection (titers ≥ 1:8) in India and the RSA
The secondary objectives of this study are:
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To describe the antibody titers to the meningococcal serogroups A, C, Y, and W:
-
before and 30 days post primary series of MenACYW conjugate vaccine and before and 30 days post booster dose of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age (Cohort II) in India and the RSA when administered concomitantly with other age-recommended vaccines.
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before and after 30 days post each dose of MenACYW conjugate vaccine or Menactra vaccine in infants and toddlers 6 months to 16 months of age (Cohort I) in India and the RSA when administered concomitantly with other age-recommended vaccines.
-
To describe the antibody responses against the antigens of the other age-recommended vaccines when administered concomitantly with MenACYW conjugate vaccine:
-
in infants and toddlers 6 weeks to 15 months of age (Cohort II) in India and the RSA.
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in infants and toddlers 6 months to 16 months of age (Cohort I) in India and the RSA.
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To describe the safety profile of MenACYW conjugate vaccine and that of licensed Menactra vaccine in infants and toddlers 6 months to 16 months of age (Cohort I) in India and the RSA when administered concomitantly with other age-recommended vaccines.
-
To describe the safety profile of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age (Cohort II) in India and the RSA when administered concomitantly with other age-recommended vaccines.
-
To describe the safety profile of age-recommended vaccines:
-
in infants 6 weeks to 15 months of age (Cohort II) in India and the RSA when administered concomitantly with MenACYW conjugate vaccine.
-
in infants and toddlers 6 months to 16 months of age (Cohort I) in India and the RSA when administered concomitantly with MenACYW conjugate vaccine.
The duration of each participant's active participation in the study will be approximately 10 to 11 months for Cohort I and 13,5 to 14,5 months for Cohort II.
详细描述
The duration of each participant's active participation in the study will be approximately 10 to 11 months for Cohort I and 13,5 to 14,5 months for Cohort II.
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
- None
入排标准
- 年龄范围
- 6 Weeks 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cohort I: 6 months of age (180 to 209 days of age) on the day of the first study visit
- •Cohort II: 6-8 weeks of age (42 to 62 days of age) on the day of the first study visit
- •Healthy infants as determined by medical history, physical examination, and judgment of the Investigator
- •Participant and parent/ legally acceptable representative (LAR) are able to attend all scheduled visits and to comply with all study procedures
- •Cohort I: Z-score ≥ -2 SD on the Weight-for-age table of the WHO Child Growth Standards.
- •Cohort II: Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg.
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 long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
- •*Note: Participants with a history of HIV but without evident severe immunosuppression can be included.
- •Family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
- •Individuals with active tuberculosis.
- •History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
- •At high risk for meningococcal infection during the study (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants 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 (GBS).
- •Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the study or to a vaccine containing any of the same substances, including neomycin, gelatin, and yeast.
- •Verbal report of thrombocytopenia, as reported by the parent/LAR, contraindicating IM vaccination in the Investigator's opinion.
- •Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination in the Investigator's opinion.
- •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, is at a stage where it might interfere with study conduct or completion.
- •Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
- •Receipt of any vaccine in the 4 weeks preceding the first study vaccination (except for Bacille Calmette-Guérin [BCG], birth dose OPV and birth dose of HepB vaccine) or planned receipt of any vaccine in the 4 weeks following each study vaccination except for the following vaccinations, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines, multivalent influenza vaccines, any COVID-19 vaccines, and administration of OPV on National Immunization Day in India.
- •Previous vaccination against meningococcal disease with either the study vaccine or another vaccine (ie, mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine).
- •For Cohort II: Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis (other than birth dose of OPV), Hepatitis A, measles, mumps, rubella, varicella; and of Hib, Streptococcus pneumoniae, and/or RV infection or disease.
- •For Cohort II: Previous vaccination with more than 1 dose of HepB 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 first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
- •Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
研究组 & 干预措施
Groups 1a, 1b and 1c Cohort Ia (India)
2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose at 12 months of age (group 1a) or at 15 months of age (group 1b) or at 16 months of age (group 1c) + co-administered routine pediatric vaccines
干预措施: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (Biological)
Groups 1a, 1b and 1c Cohort Ia (India)
2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose at 12 months of age (group 1a) or at 15 months of age (group 1b) or at 16 months of age (group 1c) + co-administered routine pediatric vaccines
干预措施: Pneumoccocal Vaccine (Biological)
Groups 1a, 1b and 1c Cohort Ia (India)
2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose at 12 months of age (group 1a) or at 15 months of age (group 1b) or at 16 months of age (group 1c) + co-administered routine pediatric vaccines
干预措施: Measles, Mumps, and Rubella Vaccine live (MMR) (Biological)
Groups 1a, 1b and 1c Cohort Ia (India)
2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose at 12 months of age (group 1a) or at 15 months of age (group 1b) or at 16 months of age (group 1c) + co-administered routine pediatric vaccines
干预措施: DTwP-HepB-Hib-IPV vaccine (Biological)
Groups 1a, 1b and 1c Cohort Ia (India)
2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose at 12 months of age (group 1a) or at 15 months of age (group 1b) or at 16 months of age (group 1c) + co-administered routine pediatric vaccines
干预措施: Hepatitis A vaccine (Biological)
Groups 1a, 1b and 1c Cohort Ia (India)
2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose at 12 months of age (group 1a) or at 15 months of age (group 1b) or at 16 months of age (group 1c) + co-administered routine pediatric vaccines
干预措施: Rotavirus vaccine (Biological)
Groups 1a, 1b and 1c Cohort Ia (India)
2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose at 12 months of age (group 1a) or at 15 months of age (group 1b) or at 16 months of age (group 1c) + co-administered routine pediatric vaccines
干预措施: Typhoid conjugate vaccine (TCV) (Biological)
Groups 1a, 1b and 1c Cohort Ia (India)
2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose at 12 months of age (group 1a) or at 15 months of age (group 1b) or at 16 months of age (group 1c) + co-administered routine pediatric vaccines
干预措施: Varicella vaccine live (Biological)
Group 2 Cohort Ia (India)
2 injections of Menactra vaccine: at 9 months of age and second dose at 16 months of age + co-administered routine pediatric vaccines
干预措施: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Biological)
Group 2 Cohort Ia (India)
2 injections of Menactra vaccine: at 9 months of age and second dose at 16 months of age + co-administered routine pediatric vaccines
干预措施: Pneumoccocal Vaccine (Biological)
Group 2 Cohort Ia (India)
2 injections of Menactra vaccine: at 9 months of age and second dose at 16 months of age + co-administered routine pediatric vaccines
干预措施: Measles, Mumps, and Rubella Vaccine live (MMR) (Biological)
Group 2 Cohort Ia (India)
2 injections of Menactra vaccine: at 9 months of age and second dose at 16 months of age + co-administered routine pediatric vaccines
干预措施: DTwP-HepB-Hib-IPV vaccine (Biological)
Group 2 Cohort Ia (India)
2 injections of Menactra vaccine: at 9 months of age and second dose at 16 months of age + co-administered routine pediatric vaccines
干预措施: Hepatitis A vaccine (Biological)
Group 2 Cohort Ia (India)
2 injections of Menactra vaccine: at 9 months of age and second dose at 16 months of age + co-administered routine pediatric vaccines
干预措施: Rotavirus vaccine (Biological)
Group 2 Cohort Ia (India)
2 injections of Menactra vaccine: at 9 months of age and second dose at 16 months of age + co-administered routine pediatric vaccines
干预措施: Typhoid conjugate vaccine (TCV) (Biological)
Group 2 Cohort Ia (India)
2 injections of Menactra vaccine: at 9 months of age and second dose at 16 months of age + co-administered routine pediatric vaccines
干预措施: Varicella vaccine live (Biological)
Groups 3 Cohort Ib (RSA)
2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
干预措施: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (Biological)
Groups 3 Cohort Ib (RSA)
2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
干预措施: Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV) (Biological)
Groups 3 Cohort Ib (RSA)
2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
干预措施: Pneumoccocal Vaccine (Biological)
Groups 3 Cohort Ib (RSA)
2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
干预措施: DTaP-IPV-Hib-HepB vaccine (Biological)
Groups 3 Cohort Ib (RSA)
2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
干预措施: Rotavirus vaccine (Biological)
Groups 3 Cohort Ib (RSA)
2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
干预措施: Measles vaccine (Biological)
Groups 3 Cohort Ib (RSA)
2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
干预措施: Varicella vaccine live (Biological)
Groups 3 Cohort Ib (RSA)
2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
干预措施: Measles, Mumps, and Rubella Vaccine live (MMR) (Biological)
Groups 3 Cohort Ib (RSA)
2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
干预措施: Hepatitis A vaccine (Biological)
Group 4 Cohort Ib (RSA)
2 injections of Menactra vaccine: at 9 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
干预措施: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Biological)
Group 4 Cohort Ib (RSA)
2 injections of Menactra vaccine: at 9 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
干预措施: Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV) (Biological)
Group 4 Cohort Ib (RSA)
2 injections of Menactra vaccine: at 9 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
干预措施: Pneumoccocal Vaccine (Biological)
Group 4 Cohort Ib (RSA)
2 injections of Menactra vaccine: at 9 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
干预措施: DTaP-IPV-Hib-HepB vaccine (Biological)
Group 4 Cohort Ib (RSA)
2 injections of Menactra vaccine: at 9 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
干预措施: Rotavirus vaccine (Biological)
Group 4 Cohort Ib (RSA)
2 injections of Menactra vaccine: at 9 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
干预措施: Measles vaccine (Biological)
Group 4 Cohort Ib (RSA)
2 injections of Menactra vaccine: at 9 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
干预措施: Varicella vaccine live (Biological)
Group 4 Cohort Ib (RSA)
2 injections of Menactra vaccine: at 9 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
干预措施: Measles, Mumps, and Rubella Vaccine live (MMR) (Biological)
Group 4 Cohort Ib (RSA)
2 injections of Menactra vaccine: at 9 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines
干预措施: Hepatitis A vaccine (Biological)
Groups 5a and 5b Cohort IIa (India)
3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered at 12 months of age (group 5a) or at 15 months of age (group 5b) + co-administered routine pediatric vaccines
干预措施: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (Biological)
Groups 5a and 5b Cohort IIa (India)
3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered at 12 months of age (group 5a) or at 15 months of age (group 5b) + co-administered routine pediatric vaccines
干预措施: Pneumoccocal Vaccine (Biological)
Groups 5a and 5b Cohort IIa (India)
3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered at 12 months of age (group 5a) or at 15 months of age (group 5b) + co-administered routine pediatric vaccines
干预措施: Measles, Mumps, and Rubella Vaccine live (MMR) (Biological)
Groups 5a and 5b Cohort IIa (India)
3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered at 12 months of age (group 5a) or at 15 months of age (group 5b) + co-administered routine pediatric vaccines
干预措施: DTwP-HepB-Hib-IPV vaccine (Biological)
Groups 5a and 5b Cohort IIa (India)
3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered at 12 months of age (group 5a) or at 15 months of age (group 5b) + co-administered routine pediatric vaccines
干预措施: Hepatitis A vaccine (Biological)
Groups 5a and 5b Cohort IIa (India)
3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered at 12 months of age (group 5a) or at 15 months of age (group 5b) + co-administered routine pediatric vaccines
干预措施: Rotavirus vaccine (Biological)
Groups 5a and 5b Cohort IIa (India)
3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered at 12 months of age (group 5a) or at 15 months of age (group 5b) + co-administered routine pediatric vaccines
干预措施: Typhoid conjugate vaccine (TCV) (Biological)
Groups 5a and 5b Cohort IIa (India)
3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered at 12 months of age (group 5a) or at 15 months of age (group 5b) + co-administered routine pediatric vaccines
干预措施: Varicella vaccine live (Biological)
Group 6 Cohort IIa (India)
routine pediatric vaccines only
干预措施: Pneumoccocal Vaccine (Biological)
Group 6 Cohort IIa (India)
routine pediatric vaccines only
干预措施: Measles, Mumps, and Rubella Vaccine live (MMR) (Biological)
Group 6 Cohort IIa (India)
routine pediatric vaccines only
干预措施: DTwP-HepB-Hib-IPV vaccine (Biological)
Group 6 Cohort IIa (India)
routine pediatric vaccines only
干预措施: Hepatitis A vaccine (Biological)
Group 6 Cohort IIa (India)
routine pediatric vaccines only
干预措施: Rotavirus vaccine (Biological)
Group 6 Cohort IIa (India)
routine pediatric vaccines only
干预措施: Typhoid conjugate vaccine (TCV) (Biological)
Group 6 Cohort IIa (India)
routine pediatric vaccines only
干预措施: Varicella vaccine live (Biological)
Group 7 Cohort IIb (RSA)
3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered between 12 and 15 months of age + co-administered routine pediatric vaccines
干预措施: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (Biological)
Group 7 Cohort IIb (RSA)
3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered between 12 and 15 months of age + co-administered routine pediatric vaccines
干预措施: Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV) (Biological)
Group 7 Cohort IIb (RSA)
3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered between 12 and 15 months of age + co-administered routine pediatric vaccines
干预措施: Pneumoccocal Vaccine (Biological)
Group 7 Cohort IIb (RSA)
3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered between 12 and 15 months of age + co-administered routine pediatric vaccines
干预措施: DTaP-IPV-Hib-HepB vaccine (Biological)
Group 7 Cohort IIb (RSA)
3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered between 12 and 15 months of age + co-administered routine pediatric vaccines
干预措施: Rotavirus vaccine (Biological)
Group 7 Cohort IIb (RSA)
3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered between 12 and 15 months of age + co-administered routine pediatric vaccines
干预措施: Measles vaccine (Biological)
Group 7 Cohort IIb (RSA)
3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered between 12 and 15 months of age + co-administered routine pediatric vaccines
干预措施: Varicella vaccine live (Biological)
Group 7 Cohort IIb (RSA)
3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered between 12 and 15 months of age + co-administered routine pediatric vaccines
干预措施: Measles, Mumps, and Rubella Vaccine live (MMR) (Biological)
Group 7 Cohort IIb (RSA)
3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered between 12 and 15 months of age + co-administered routine pediatric vaccines
干预措施: Hepatitis A vaccine (Biological)
Group 8 Cohort IIb (RSA)
routine pediatric vaccines only
干预措施: Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV) (Biological)
Group 8 Cohort IIb (RSA)
routine pediatric vaccines only
干预措施: Pneumoccocal Vaccine (Biological)
Group 8 Cohort IIb (RSA)
routine pediatric vaccines only
干预措施: DTaP-IPV-Hib-HepB vaccine (Biological)
Group 8 Cohort IIb (RSA)
routine pediatric vaccines only
干预措施: Rotavirus vaccine (Biological)
Group 8 Cohort IIb (RSA)
routine pediatric vaccines only
干预措施: Measles vaccine (Biological)
Group 8 Cohort IIb (RSA)
routine pediatric vaccines only
干预措施: Varicella vaccine live (Biological)
Group 8 Cohort IIb (RSA)
routine pediatric vaccines only
干预措施: Measles, Mumps, and Rubella Vaccine live (MMR) (Biological)
Group 8 Cohort IIb (RSA)
routine pediatric vaccines only
干预措施: Hepatitis A vaccine (Biological)
结局指标
主要结局
Percentage of participants with anti-meningococcal serogroups A, C, Y, W antibody titers above predefined thresholds after 2 doses of MenACYW conjugate vaccine compared to 2 doses of Menactra® vaccine in infants and toddlers 6 months to 16 months of age
时间窗: 30 days after the second vaccination
Antibody (Ab) titers against meningococcal serogroups A, C, Y, and W will be measured in infants and toddlers 6 months to 16 months of age (\[Group 1 + Group 3\] versus \[Group 2 + Group 4\]) The following threshold values will be considered: ≥ 1:8
Percentage of participants with anti-meningococcal serogroups A, C, Y, W Ab titers above predefined thresholds after 3 doses of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age
时间窗: 30 days after the booster vaccination
Ab titers against meningococcal serogroups A, C, Y, and W will be measured in infants and toddlers 6 months to 15 months of age (Group 5 + Group 7) The following threshold values will be considered: ≥ 1:8
次要结局
- Geometric Mean Titers (GMTs) of Ab against meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine administered concomitantly with other age-recommended vaccine in infants 6 weeks to 15 months of age(Baseline; 30 days after primary series of vaccination; Before and 30 days after booster vaccination)
- Geometric Mean Titers Ratio (GMTR) of Ab against meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine administered concomitantly with other age-recommended vaccine in infants 6 weeks to 15 months of age(Baseline; 30 days after primary series of vaccination; Before and 30 days after booster vaccination)
- GMTs of Ab against meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine or Menactra vaccine when administered concomitantly with other age-recommended vaccines in infants and toddlers 6 months to 16 months of age(Baseline; Before and 30 days after each vaccination)
- GMTR of Ab against meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine or Menactra vaccine when administered concomitantly with other age-recommended vaccines in infants and toddlers 6 months to 16 months of age(Baseline; Before and 30 days after each vaccination)
- Percentage of participants with anti-meningococcal serogroups A, C, Y, and W Ab titers met the predefined criteria when MenACYW conjugate vaccine administered concomitantly with other age-recommended vaccine in infants 6 weeks to 15 months of age(Baseline; 30 days after primary series of vaccination; Before and 30 days after booster vaccination)
- Percentage of participants with anti-meningococcal serogroups A, C, Y, and W Ab titers met the predefined criteria when MenACYW conjugate vaccine administered concomitantly with other age-recommended vaccine in infants and toddlers 6 to 16 months of age(Baseline; Before and 30 days after each vaccination)
- GMCs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age(Baseline)
- GMCR of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age(Baseline)
- GMCs/GMTs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age(-30 days after:-Dose3 of DTwP-HepB-Hib-IPV/DTaP-IPV-Hib-HepB;-1ry series of PCV13;-measles,mumps & rubella: Dose1 in RSA;Dose2 in India;-1st dose of varicella vaccine -30 days at least after booster dose of PCV13 -Before & 30 days after 1ry series of RV)
- GMCRs/GMTRs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 weeks to 15 months of age(-30days after:-1ry series of DTwP-HepB-Hib-IPV/DTaP-IPV-Hib-HepB;-1ry series of PCV13;-measles,mumps & rubella:Dose1 in RSA;Dose2 in India;-1st dose of varicella vaccine -30days at least after booster dose of PCV13 -Before&30 days after 1ry series of RV)
- Percentage of participants with Ab concentrations/titers met the predefined criteria in infants and toddlers 6 weeks to 15 months of age(30 days after: - Primary series of RV - Dose 1 of measles, mumps and rubella in RSA - Dose 2 of measles, mumps and rubella in India - first dose of varicella vaccine)
- GMCs/GMTs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age(30 days after: - first dose of varicella vaccine - the booster dose of PCV13 - Dose 1 of measles, mumps and rubella in RSA - Dose 2 of measles, mumps and rubella in India - after booster dose of DTwP-HepB-Hib-IPV)
- GMCRs/GMTRs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age(30 days after: - first dose of varicella vaccine - the booster dose of PCV13 - Dose 1 of measles, mumps and rubella in RSA - Dose 2 of measles, mumps and rubella in India - after booster dose of DTwP-HepB-Hib-IPV)
- Percentage of participants with Ab concentrations/titers met the predefined criteria in infants and toddlers 6 months to 16 months of age(30 days after booster dose of DTwP-HepB-Hib-IPV)
- GMCs of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age(Pre-booster dose vaccination of DTwP-HepB-Hib-IPV)
- GMCR of Ab against the antigens of age-recommended vaccines in infants and toddlers 6 months to 16 months of age(Pre-booster dose vaccination of DTwP-HepB-Hib-IPV)
- Number of participants reporting immediate adverse events (AEs)(Within 30 minutes post-vaccination)
- Percentage of participants reporting solicited injection site and systemic reactions(Within 7 days post-vaccination)
- Number of participants reporting unsolicited AEs(Up to Day 31 post-vaccination)
- Number of participants reporting serious adverse events (SAEs)(From Day 1 to Month 18)