NCT00802867已完成4 期
Safety and Immunogenicity of DAPTACEL® (CP10/5/5/3DT Aventis Pasteur 5-component Pertussis Vaccine in Combination With Tetanus and Diphtheria Toxoids Adsorbed) Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™ (HCP20/20/5/3DT-mIPV//PRP-T)
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 989
- 试验地点
- 19
- 主要终点
- Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel®
研究概览
简要总结
Objectives:
- To present the rates of adverse reactions after a dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.
- To present immunogenicity before and after a single dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.
详细描述
This study is designed to assess the safety and immunogenicity of DAPTACEL® vaccine administered at 4 to 6 years of age according to the US standard of care. The study population consists of PENTACEL™-primed subjects from Aventis Pasteur's pivotal studies 494-01 and 494-03. These children will receive DAPTACEL® vaccine as a 5th dose immunization between 4 to 6 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥ 4 years and 6 years.
- •Signed and dated Investigational Review Board-approved informed consent from a parent or legally authorized representative.
- •Judged to be in good health on the basis of reported medical history and physical examination.
- •Able and willing to attend the scheduled visits and to comply with the study procedures.
- •Has documented complete infant series and 4th dose in Study 494-01 or Study 494-03, consisting of four previous administrations of PENTACEL™.
排除标准
- •Received a 5th dose of DTaP-containing vaccine scheduled at 4 to 6 years of age.
- •Serious underlying chronic disease, including, but not limited to:
- •Diabetes mellitus; malignancy; cardiopulmonary disease; renal, endocrinologic, or hepatic dysfunction; or hematologic disorder; or
- •Unstable or evolving neurologic disorders that may predispose the subject to seizures or neurologic deterioration.
- •Known or suspected primary or acquired disease of the immune system.
- •Administration of immune globulin or other blood products within the last 3 months, or injected or oral corticosteroids or other immunomodulatory therapy within 6 weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting <7 days may be included in the trial as long as they have not received more than 1 course within the last 2 weeks prior to enrollment.
- •Had allergy shots started or had changes in regimen or dosing of allergy shots within the last 4 weeks.
- •Receipt of any other vaccine within the past 30 days, or planning to receive another vaccine within 30 days before the Visit 2 blood draw, with the exclusion of M-M-R®II and IPV.
- •Any other condition which, in the opinion of the Investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
- •Enrolled in another vaccine trial.
- •Personal history of physician-diagnosed or laboratory-confirmed pertussis disease within the past 30 months.
- •Known or suspected allergy to any of the vaccines or vaccine components intended for use in this study.
- •Temporary contraindications:
- •A subject who meets either of the following criteria at the time of planned vaccination will have enrollment deferred until complete resolution of symptoms:
- •Oral temperature ≥ 100.4°F (≥ 38.0ºC) (Note: A tympanic thermometer should not be used).
- •Any moderate or severe acute illness with or without fever.
研究组 & 干预措施
1
Experimental
Subjects in Study 494-01 and Study 494-03 who had received 4 doses of Pentacel™ vaccine.
干预措施: Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®) (Biological)
结局指标
主要结局
Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel®
时间窗: 0 to 3 days post-dose 5 vaccination
Solicited local reactions: Redness, swelling, tenderness at injection site, change in limb circumference, and limb function. Systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash.
次要结局
未报告次要终点
研究者
研究点 (19)
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