A Phase 2, Randomized, Active-controlled, Observer-blinded Trial, To Assess The Safety, Tolerability, And Immunogenicity Of Mcv4, Tdap Vaccine And Bivalent Rlp2086 Vaccine When Administered Concomitantly In Healthy Subjects Aged > = 10 To <13 Years
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 2,648
- 试验地点
- 215
- 主要终点
- Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens
研究概览
简要总结
This is a clinical study to assess the safety, tolerance and immunogenic response to MCV4(quadrivalent meningococcal polysaccharide conjugate, meningococcal serogroups A,C,Y, and W135), Tdap (diphtheria, tetanus, and acellular pertussis), and bivalent rLP2086 vaccine. Healthy male and female subjects, between the ages of 10 to 12 years old, will be randomized into 1 of 3 groups. The subjects, investigators, site staff and sponsor will be blinded to all injections given throughout the study. An unblinded administrator will be responsible to administer the vaccinations to all subjects and will be unblinded to the subject randomization in order to determine which subjects were in randomized to group 3 so they may receive their catch-up vaccinations of MCV4 and Tdap. A final telephone contact will be conducted with all subjects 6-months post their last vaccination to obtain safety information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject (and a legally authorized representative) has been informed of all pertinent aspects of the study.
- •Parent /legally authorized representative and subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
- •Male or female subject aged greater than or equal to 10 and <13 years at the time of enrollment.
- •Available for the entire study period and can be reached by telephone.
- •Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
- •Has received full series (5-dose series is preferred, 4-dose catch up series is allowed) of diphtheria, tetanus and pertussis (whole cell or acellular) vaccines per country specific recommendations applicable at the time of receipt.
- •Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study.
排除标准
- •Previous vaccination with any meningococcal serogroup B vaccine.
- •Vaccination with any diphtheria, tetanus or pertussis vaccine within 5 years of the first study vaccination.
- •Previous vaccination with any MCV4 vaccine.
- •A previous anaphylactic reaction to any vaccine or vaccine-related component.
- •Contraindication to vaccination with MCV4 and/or Tdap vaccine.
- •Subjects receiving any allergen immunotherapy with a non-licensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
- •Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- •A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects with terminal complement deficiency may not be included.
- •History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoea.
- •Significant neurological disorder or history of seizure (excluding simple febrile seizure).
- •Receipt of any blood products, including immunoglobulin within 6 months before the first study vaccination.
- •Current chronic use of systemic antibiotics.
- •Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
研究组 & 干预措施
MCV4 + Tdap + saline
Group 2, MCV4 + Tdap+ saline
干预措施: MCV4 + Tdap + saline (Biological)
MCV4 + Tdap+ rLP2086
Group 1 - MCV4 + Tdap + rLP2086
干预措施: rLP2086 + MCV4 + Tdap (Biological)
Saline + saline + rLP2086
Group 3- rLP2086 + saline
干预措施: rLP2086 + saline (Biological)
结局指标
主要结局
Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens
时间窗: 1 Month after Vaccination 1
Antibody GMCs of 2 antigens of diphtheria and tetanus toxoid were computed in International Units per milliliter (IU/mL) along with corresponding 2-sided 95 percent (%) confidence intervals (CIs). Here, 'number of participants analyzed' signifies participants with valid and determinate assay results for given antigen.
Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3
时间窗: 1 Month after Vaccination 3
Antibody hSBA GMTs of primary strain PMB80 \[A22\] and PMB2948 \[B24\] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.
Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens
时间窗: 1 Month after Vaccination 1
Antibody GMCs of 4 acellular pertussis antigens (pertussis toxoid, pertussis filamentous hemagglutinin, pertussis pertactin and pertussis fimbrial agglutinogens types 2+3) were computed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL) along with corresponding 2-sided 95% CIs.
Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens
时间窗: 1 Month after Vaccination 1
Antibody GMTs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) were computed along with corresponding 2-sided 95% CIs.
次要结局
- Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level(Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3)
- Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens(1 Month after Vaccination 1)
- Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2(Before Vaccination 1, 1 Month after Vaccination (Vac) 2)
- Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ)(Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3)
- Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens(1 Month after Vaccination 1)