EUCTR2015-003914-25-Outside-EU/EEA进行中（未招募）不适用
Clinical Safety Study of the Tdap Combined Vaccine (ADACEL) as a Booster Dose in Healthy Adults and Children in China
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •An individual had to fulfill all of the following criteria in order to be eligible for trial
- •enrollment:
- •1) Group 1: Aged 18 through 64 years on the day of inclusion
- •Group 2: Aged 4 through 8 years on the day of inclusion
- •2) Informed consent form (ICF) signed by the subject (Group 1) or by the parent(s) or legal representative (Group 2)
- •3) Subject (Group 1 and 2) and parent/legal representative (Group 2 only) able to attend all scheduled visits and to comply with all trial procedures
- •4) Group 1 only: For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) from at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination
- •5) Group 2 only: Written documentation of complete primary series and fourth dose of DTP vaccine as per China National Immunization Recommendations.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •An individual fulfilling any of the following criteria had to be excluded from trial enrollment:
- •1) Group 1 only: For a woman of child-bearing potential, known pregnancy or positive serum or urine pregnancy test
- •2) Group 1 only: Currently breast-feeding a child
- •3) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination
- •4) Planned participation in another clinical trial during the present trial period
- •5) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- •6) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine or to a vaccine containing any of the same substances
- •7) Chronic illness that, in the opinion of the Investigator, is at a stage that could interfere with trial conduct or completion
- •8) Group 1 only: Current alcohol abuse or drug addiction that may interfere with the ability to comply with trial procedures
- •9) Receipt or planned receipt of any vaccine in the 4 weeks preceding or following trial vaccination, except for influenza vaccination, which may be received at least two weeks before the study vaccine
- •10) Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
- •11) History of diphtheria, tetanus, or pertussis infection (confirmed either clinically, serologically or microbiologically)
- •12) Previous fifth vaccination against pertussis disease and/or previous sixth vaccination against diphtheria and tetanus disease with either the trial vaccine or another vaccine (except Tetanus-prone wound management in Group 1)
- •13) Subject at high risk for diphtheria, tetanus, or pertussis infection during the trial, including persons who have exposure (e.g., member of a household with
- •another infected member, travelers to or residents of areas where one of this disease is hyperendemic or epidemic, or microbiologists routinely working with one of these pathogens)
- •14) Self-reported thrombocytopenia, bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
- •15) Group 1 only: Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- •16) History of contra-indication to vaccination with pertussis containing vaccine, including:
- •- Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that was not attributable to another identifiable cause
- •17) Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as immediate family members (i.e. husband, wife and their children, adopted or natural) of the employees or the Investigator.
- •Temporary Contraindications:
- •A prospective subject had not to be included in the study until the following conditions
- •and/or symptoms were resolved:
- •18) Febrile illness (axillary temperature =37.1°C) or moderate or severe acute illness/infection on the da
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