CTRI/2012/02/002452已完成3 期
A Phase 3, Multi-center, Open-label study to evaluate immunogenicity and safety ofNovartis Meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy subjects from 2 to 75 years of age in India.
ovartis Healthcare Pvt Ltd Vaccines Diagnostics0 个研究点目标入组 180 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
- 180
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
- •Individuals eligible for enrolment in this study are those:
- •1. who are of any gender, from the age of 2 to 75 years at the time of visit 1, and to whom the nature of the study has been explained and:
- •the parent/legal representative has provided written informed consent (greater than or equal to 2 - less than 18 years of age).
- •have provided written assent (greater than or equal to 7-less than or equal to 18 years)
- •have provided written informed consent (greater than or equal to 18 to 75 years of age).
- •2. who the investigator believes that they or their parents/legal representatives can and
- •will comply with the requirements of the protocol (e.g., completion of the Diary Card, return for follow-up visit).
- •3. who are in good health as determined by
- •medical history, physical exam, clinical judgment of the investigator
- •4. who have a negative urine pregnancy test for female subjects of childbearing potential
排除标准
- •Individuals not eligible to be enrolled in the study are those:
- •1. who are unwilling or unable to give written informed assent or consent to participate in the study.
- •2. who are perceived to be unreliable or unavailable for the duration of the study period.
- •3. who had a previous or suspected disease caused by N. meningitidis.
- •4. who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrolment.
- •5. who have previously been immunized with a meningococcal vaccine.
- •6. who have received any investigational or non-registered product (drug or vaccine)within 28 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study.
- •7. who have received any vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 30 days from the study vaccines. (Exception: Influenza vaccine may be administered up to 15 days prior to study vaccination and at least 15 days after study vaccination)
- •8. who have experienced within the 7 days prior to enrolment significant acute infection (for example requiring systemic antibiotic treatment or antiviral therapy) or have experienced fever (defined as body temperature greater than or equal to 38°C) within 3 days prior to enrolment.
- •9. who have any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV infection or AIDS, or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition). who have epilepsy or any progressive neurological disease.
- •11. who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components.
- •12. who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
- •receipt of immunosuppressive therapy within 28 days prior to enrolment (any systemic corticosteroid administered for more than 5 days, or in a daily dose greater than 1 mg/kg/day prednisone or equivalent during any of 28 days prior to enrolment, or cancer chemotherapy)
- •receipt of immunostimulants
- •receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrolment and for the full length of the study
- •13. who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- •14. who have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
研究者
相似试验
进行中（未招募）
不适用
Immunogenicity and safety of Novartis Meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy subjects from 2 to 75 years of age in India.Prophylaxis against Neisseria meningitidis serogroups A, C, W, and YEUCTR2014-004477-16-Outside-EU/EEAovartis Healthcare Pvt. Ltd., Vaccines Division180
尚未招募
3 期
A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic PsoriasisGeneralized Pustular PsoriasisErythrodermic PsoriasisJPRN-jRCT2071230104akano Masayoshi16
进行中（未招募）
3 期
Study to evaluate the efficacy, pharmacokinetics, safety, and immunogenicity of subcutaneously administered ustekinumab or guselkumab in pediatric participants with active juvenile psoriatic arthritisISRCTN49107623Janssen-Cilag International NV80
已完成
3 期
A phase 3, multi-center, open label study to evaluate safety and efficacy of AK1820 for treatment of adult Japanese patients with deep mycosis.Deep mycosisJPRN-jRCT2080223864ASAHI KASEI PHARMA CORPORATIO103
进行中（未招募）
1 期
A clinical study to evaluate immune responses to rabies vaccine in adults who received different primary rabies vaccination regimens.MedDRA version: 20.0Level: PTClassification code 10037742Term: RabiesSystem Organ Class: 10021881 - Infections and infestationsRabiesEUCTR2015-000382-31-ATGlaxoSmithKline Biologicals S.A.578