NCT00798304终止2 期
An Open Label, Randomized, Phase 1/2 Trial Of The Safety, Tolerability, And Immunogenicity Of Meningococcal Group B Rlp2086 Vaccine In Healthy Infants
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 46
- 试验地点
- 14
- 主要终点
- Percentage of Participants Achieving at Least 1:4 rLP2086-specific Serum Bactericidal Assay (SBA) Titer to 1 Subfamily A Strain and 1 Subfamily B Strain
研究概览
简要总结
The primary purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B vaccine in healthy infants.
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
- 42 Days 至 98 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Investigators should always use good clinical judgment in considering a subject's overall fitness for trial participation. In addition, any condition that in the opinion of the investigator may interfere with the evaluation of study objectives should be carefully considered prior to enrolling subjects.
- •Male or female subjects aged 2 months (42 to 98 days of age) at the time of enrollment.
- •Available for the entire consented period and whose parent/legal guardian can be reached by telephone.
- •Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
- •Parent/legal guardian must be able to complete all relevant study procedures during study participation.
排除标准
- •Previous vaccination with licensed or investigational vaccines: meningococcal B, meningococcal C, pneumococcal, Hib, diphtheria, tetanus, acellular pertussis, poliovirus, rotavirus, varicella, measles, mumps, or rubella.
- •Any of the following illnesses/conditions that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study:
- •A previous anaphylactic reaction to any vaccine or vaccine-related component.
- •Contraindication to vaccination with meningococcal B, meningococcal C, pneumococcal, Hib, diphtheria, tetanus, acellular pertussis, Hepatitis B (HBV), poliovirus, rotavirus, varicella, measles, mumps, or rubella.
- •Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- •Known or suspected immune deficiency or suppression.
- •History of culture-proven invasive disease caused by N meningitidis or Neisseria gonorrhoea.
- •Major known congenital malformation or serious chronic disorder.
- •Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder.
- •Does not include resolving syndromes due to birth trauma such as Erb palsy.
- •Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies).
- •Received any investigational drugs, vaccines or devices (aside from those specified in the protocol) within 4 weeks before administration of the first dose of test article or at any time throughout the study.
- •Participation in purely observational studies is acceptable.
- •Infant who is a direct descendant (child, grandchild) of the study site personnel.
结局指标
主要结局
Percentage of Participants Achieving at Least 1:4 rLP2086-specific Serum Bactericidal Assay (SBA) Titer to 1 Subfamily A Strain and 1 Subfamily B Strain
时间窗: 1 month after Dose 3
Percentage of Participants With at Least One Adverse Event (AE)
时间窗: From signing of informed consent form to completion of study (up to 2 years)
次要结局
- Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs) for 1 Subfamily A Strain and 1 Subfamily B Strain(1 month after Dose 2, Dose 3; before Dose 4)
- Percentage of Participants Achieving at Least 1:4, 1:8, 1:16, 1:32, 1:64, 1:128 rLP2086-specific SBA Titer to 1 Subfamily A Strain and 1 Subfamily B Strain(1 month after Dose 2, Dose 3; before Dose 4)
研究者
研究点 (14)
Loading locations...
相似试验
尚未招募
1 期
A Study in Subjects With Human Papillomavirus 16 or 18 Associated Cervical Intraepithelial Neoplasia Grade 2 or 3Human Papillomavirus Associated Intraepithelial NeoplasiaCervical Intraepithelial Neoplasia Grade 2/3Human Papillomavirus Type 16 InfectionHuman Papillomavirus Type 18 InfectionNCT06273553RinuaGene Biotechnology Co., Ltd.39
已完成
2 期
A Study of the Efficacy and Safety of the LEISH-F2 + MPL-SE Vaccine for Treatment of Cutaneous LeishmaniasisCutaneous LeishmaniasisNCT01011309Access to Advanced Health Institute (AAHI)45
已完成
2 期
Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected PatientsHIV InfectionsNCT00316589Bavarian Nordic581
进行中（未招募）
2 期
To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KP104Paroxysmal Nocturnal HemoglobinuriaNCT05476887Kira Pharmacenticals (US), LLC.35
已完成
1 期
Safety, Tolerability and Immune Response of IMVAMUNE (MVA-BN)Smallpox Vaccine in HIV Infected PatientsHIV InfectionsNCT00189904Bavarian Nordic151