NCT01839175已完成3 期
A Phase III Open-label Randomised Study to Evaluate the Immunogenicity and Safety of the Concomitant Administration of a New Hexavalent DTaP-IPV-HepB-PRP-T Combined Vaccine (Hexavalent Vaccine) Given at 2, 3, and 4 Months of Age With a Meningococcal Serogroup C Conjugate (MenC) Vaccine Given at 2 and 4 Months of Age
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 12
- 主要终点
- Proportion of subjects with an anti-hepatitis B concentration ≥10 IU/mL
研究概览
简要总结
Primary Series Primary objectives
- To demonstrate that the concomitant administration of the hexavalent vaccine with a meningococcal serogroup C conjugate vaccine is non inferior to the administration of the hexavalent vaccine without a MenC vaccine concomitantly in term of seroprotection rate for hepatitis B one month after the third dose of the hexavalent vaccine
- To demonstrate that the concomitant administration of a MenC vaccine with the hexavalent vaccine induces an acceptable response for MenC in term of seroprotection rate (SPR) one month after the second dose of MenC
Booster Primary objectives
- To describe the immunogenicity of a booster dose of the hexavalent vaccine and of a meningococcal group ACWY conjugate (MenACWY) vaccine either co-administered at 12 months of age or given separately.
详细描述
Primary Series Secondary objectives
- To describe the antibody response to all the hexavalent vaccine antigens one month after the third dose of the hexavalent vaccine when given concomitantly or not to MenC
- To describe the antibody response to MenC vaccine when a MenC vaccine is given concomitantly with the hexavalent vaccine, one month after the first and the second dose of MenC vaccine
- To describe the safety profile of the hexavalent vaccine after each and any injection when given concomitantly or not with a MenC vaccine
Booster Secondary objectives
- To describe the antibody (Ab) persistence at 12 months of age for the hexavalent valences following a 3-dose primary vaccination at 2, 3 and 4 months of age (prior to administration of a booster dose)
- To describe the safety of a booster dose of the hexavalent vaccine and of a meningococcal group ACWY conjugate (MenACWY) vaccine either co-administered at 12 months of age or given separately.
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
- 46 Days 至 76 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infant 46 to 74 days of age (both inclusive)
- •Born at full term of pregnancy (≥37 weeks) and/or with a birth weight≥2.5 kg
- •Subject's parent(s) or legal representative able to comply with the study procedures
排除标准
- •Participation in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- •Receipt of any vaccine in the 4 weeks preceding each study vaccination
- •Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, meningococcal, pneumococcal, rotavirus infection
- •Know or suspected congenital, hereditary or acquired immunodeficiency
- •History of seizures or encephalopathy
- •Known thrombocytopenia
- •Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection
- •Chronic illness that could interfere with trial conduct or completion
- •Known or suspected hypersensitivity to any of the study vaccines' active substance or excipients or history of a life-threatening reaction to a vaccine(s) containing the same substances as the study vaccines
- •Contraindication to any of the study vaccines
- •Known personal or maternal history of hepatitis B or hepatitis C seropositivity
- •History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b or meningococcal serogroup C infection
- •Receipt of immune globulin, blood or blood-derived products, immunosuppressive drugs, systemic corticosteroid since birth
- •Identified as a natural or adopted child of the investigator or employee with direct involvement in the current study.
结局指标
主要结局
Proportion of subjects with an anti-hepatitis B concentration ≥10 IU/mL
时间窗: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)
Proportion of subjects with an anti-MenC titre ≥1:8 dil
时间窗: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)
次要结局
- Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL(Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster))
- Proportion of subjects with an anti-MenC titre ≥1:8 dil(Month 3 (One month after dose 1 of MenC vaccine))
- Proportion of subjects with an anti-polyribosylribitol phosphate concentration ≥1 µg/mL(Month 12 (Pre-booster) and Month 13 (One month post-booster))
- Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL(Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster))
- Proportion of subjects with an anti-polyribosylribitol phosphate concentration ≥0.15 µg/mL(Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) and Month 13 (One month post-booster))
- Proportion of subjects with an anti-inactivated poliovirus 1, 2, 3 titre ≥1:8 dil(Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) and Month 13 (One month post-booster))
- Proportion of subjects with pertussis vaccine response(Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine))
- Solicited injection-site and systemic reactions(Day 1 to Day 7 following vaccination)
- Unsolicited adverse events(Day 1 to Day 30 following vaccination)
- Serious adverse events(From signature of the informed consent to the last visit of the subject, an expected average of 11 months)
- Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL(Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) and Month 13 (One month post-booster))
- Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL(Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) and Month 13 (One month post-booster))
- Proportion of subjects with pertussis booster response(Month 13 (One month post-booster))
- Proportion of subjects with an anti-MenA, anti-MenC, anti-MenW-135, anti-MenY titre ≥1:8 dil(Month 13 (One month after MenAWCY vaccine))
- Proportion of subjects with an anti-hepatitis B concentration ≥10 IU/mL(Month 12 (Pre-booster) and Month 13 (One month post-booster))
研究者
研究点 (12)
Loading locations...
相似试验
已完成
3 期
A Study of V503 Vaccine Given Concomitantly With REPEVAX™ in 11 to 15 Year Olds (V503-007)Papillomavirus InfectionsNCT01073293Merck Sharp & Dohme LLC1,054
已完成
3 期
Immunogenicity and Safety of V419 (PR51) in Combination With MCC in Infants and Toddlers (V419-011)Neisseria MeningitidisBacterial InfectionsVirus DiseasesNCT01553279MCM Vaccines B.V.284
已完成
3 期
Pyronaridine - Artesunate (3:1) Versus Mefloquine Plus Artesunate in Plasmodium Falciparum Malaria PatientsFalciparum MalariaNCT00403260Medicines for Malaria Venture1,271
尚未招募
不适用
A randomized, open-label phase III study of first line chemotherapy in older metastatic breast cancer patients, comparing intravenous pegylated liposomal doxorubicin with oral capecitabine; and the incorporation of a complete geriatric assessment.Metastatic breastcancer in elderly patients.Gemetastaseerd borstkanker bij oudere patienten.NL-OMON25134Borstkanker Onderzoeks Groep (BOOG)Plesmanlaan 1251066 CX Amsterdam00-31-(0)20-346 2547boog@ikca.nl154
终止
3 期
A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)Acute Myeloid Leukemia (AML)CancerNCT04161885AbbVie465