NCT01323270已完成2 期
A Phase 2, Randomized, Placebo-controlled, Single-blind Trial To Assess The Safety, Tolerability, And Immunogenicity Of Repevax(Registered) And Bivalent Rlp2086 Vaccine When Administered Concomitantly In Healthy Subjects Aged Greater Than Or Equal To 11 To <19 Years
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 753
- 试验地点
- 36
- 主要终点
- Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen
研究概览
简要总结
This study is to look at a new vaccine that might prevent meningococcal disease, and to look at the safety of the new vaccine as well as how it is tolerated when given together with Repevax. The study will be done in healthy adolescents.
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
- Single (Participant)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 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 indicating that the parent/legally acceptable representative and/or subject has been informed of all pertinent aspects of the study.
- •Parent/legally acceptable representative and/or subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
- •Male or female subject aged ≥11 and <19 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 of diphtheria, tetanus, and pertussis (DTP)/DTaP vaccines and oral poliomyelitis virus (OPV)/IPV vaccines per country-specific recommendations applicable at the time of receipt.
- •All male and female subjects must agree to practice a form of effective contraception, such as barrier contraception (ie, condom plus spermicide, a female condom, diaphragm, cervical cap or intrauterine device), implants, injectables, combined oral contraceptives or sexual abstinence prior to entering into the study, for the duration of the vaccination period and for 28 days after the last study vaccination. For Germany: The phrase sexual abstinence is not applicable, with the understanding that all male and all female subjects of childbearing potential must practice an effective form of contraception during the study.
- •Negative urine pregnancy test for female subjects.
排除标准
- •Previous vaccination with any meningococcal serogroup B vaccine.
- •Vaccination with any diphtheria, tetanus, pertussis, or poliomyelitis virus vaccine within 5 years of the first study vaccination.
- •A previous anaphylactic reaction to any vaccine or vaccine-related component.
- •Contraindication to vaccination with diphtheria, tetanus, pertussis, or poliomyelitis virus vaccine.
- •Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- •A known or suspected disease of the immune system or those receiving immunosuppressive therapy.
- •History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae.
- •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.
- •Participation in other studies during study participation. Participation in purely observational studies is acceptable.
- •Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination.
- •Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- •Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
- •Subject is a direct descendant (eg, child, grandchild or other family member) of study site or Pfizer personnel.
- •Subject is pregnant or breastfeeding.
研究组 & 干预措施
Saline and Repevax
Placebo Comparator
Saline and Repevax
干预措施: Saline (Biological)
Saline and Repevax
Placebo Comparator
Saline and Repevax
干预措施: Repevax (Biological)
rLP2086
Experimental
rLP2086 and Repevax
干预措施: Repevax (Biological)
rLP2086
Experimental
rLP2086 and Repevax
干预措施: rLP2086 (Biological)
结局指标
主要结局
Percentage of Participants Achieving Prespecified Criteria for the Concomitant Antigen
时间窗: 1 month after Vaccination 1
Percentage of Participants With at Least One Adverse Event (AE)
时间窗: Vaccination 1 up to 1 month after Vaccination 3
次要结局
- Geometric Mean Concentration (GMC) for Diphtheria and Tetanus Antigens(1 month after Vaccination 1)
- GMC for Acellular Pertussis Antigens(1 month after Vaccination 1)
- Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal to (>=) Prespecified Titer Level(1 month after Vaccination 3)
- Geometric Mean Titer (GMT) for Poliomyelitis Antigens(1 month after Vaccination 1)
研究者
研究点 (36)
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