CTRI/2010/091/000157已完成3 期
Safety and Immunogenicity Study for Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Healthy Subjects 2-55 Years of Age in India.
Sanofi Pasteur SA0 个研究点目标入组 300 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Aged 2 to 11 years or Aged 12 to 17 years or Aged 18 to 55 years of age on the day of inclusion
- •For participants aged 2 to 11 years: Provision of informed consent form signed by the parent(s) or legal representative.
- •For participants aged 12 to 17 years: Provision of assent form signed by the participant and informed consent form signed by the parent(s) or legal representative.
- •For participants aged 18 to 55 years: Provision of informed consent form signed by the participant. If the participant or the participant's parents or legally accepted representative (participants aged 2 to 17 years) are illiterate, an independent witness is required to sign the consent form.
- •Participant and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and comply with all trial procedures
- •For a woman of child-bearing potential, sexually active, use of a medically acceptable and effective method of contraception for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination (not applicable for participants aged 2 to 17 years' females not of child-bearing potential or not sexually active)
排除标准
- •1) For a woman of child-bearing potential sexually active, known or suspected pregnancy or positive serum/urine pregnancy test (not applicable for participants aged 2 to 17 years females not of child-bearing potential or not sexually active).
- •2) Breast-feeding woman.
- •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
- •Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
- •5) Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances.
- •6) Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator.
- •7) Current alcohol abuse or drug addiction that may interfere with the subjects ability to comply with trial procedures.
- •8) Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response.
- •9) Receipt or planned receipt of any vaccine (other than influenza vaccine which can be given 2 weeks or more before vaccination) in the 4 weeks preceding or following the trial vaccination.
- •10) Known Human Immunodeficiency Virus (HIV), Hepatitis B surface (HBs) antigen , or Hepatitis C seropositivity as reported by the participant/parent/guardian and/or based on medical history.
- •11) History of documented invasive meningococcal disease.
- •12) Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine.
- •13) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination.
- •14) Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- •15) Personal or family history of Guillain-Barré Syndrome.
- •Temporary contraindications delaying vaccination until resolved:
- •- Febrile illness (temperature >=38.0°C) or moderate or severe acute illness/infection on the day of vaccination.
- •- Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw.
研究者
相似试验
进行中（未招募）
不适用
Safety and Immunogenicity Study for Use of Menactra® Versus Adacel® in Subjects 11 to 55 Years of Age in South KoreaTo prevent Meningococcal meningitis and sepsis caused by Neisseria meningitidis.EUCTR2015-005181-33-Outside-EU/EEASanofi Pasteur SA300
已完成
不适用
Study for effects of Haemophilus Influenzae type b conjugate vaccine in childreChildren Haemophilus Meningitis.Meningitis due to Haemophilus influenzaeIRCT201008084536N1Masoondarou Co.50
已完成
3 期
Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian FederatioCTRI/2014/12/005272Sanofi Pasteur SA300
招募中
3 期
Clinical Trial of quadrivalent Papilloguard4 vaccine (Human Papillomavirus Types 6, 11, 16, 18) manufactured by Nivad Pharmed Salamat in comparison with GardasilGenital wart prevention.Anogenital (venereal) wartsA63.0IRCT20240120060741N1ivad Pharmed Salamat670
已完成
不适用
Evaluation of a prototype vaccine against enterotoxigenic Escherichia coli diarrhoeaEnterotoxigenic E. coli (ETEC) diarrhoeaInfections and InfestationsEnterotoxigenic Escherichia coli infectionISRCTN23764070Gothenburg University Vaccine Research Institute (GUVAX) (Sweden)60