TCTR20190625002已完成3 期
A Phase III double-blinded, three-arm, randomized, controlled trial to evaluate the clinical efficacy, immunogenicity, safety, and lot-to-lot consistency of Tri Fluvac, a seasonal trivalent inactivated split virion influenza vaccine, in healthy Thai
The Goverment Pharmaceutical Organization0 个研究点目标入组 4,260 人开始时间: 2019年6月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4,260
研究概览
简要总结
The GPO Trifluvac was well tolerated, immunogenicity was non inferior and met US FDA criteria for adult vaccine licensure.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 64 Years（—）
- 性别
- All
入选标准
- •Age 18-64 years old on the day of vaccination, having Thai ID card or equivalent
- •Able to read and write in Thai and sign written informed consent form
- •Able to attend all scheduled visits and to comply with all trial procedures.
- •Healthy or medically stable, as established by medical history and physical examination.
- •For female participants of reproductive age (18-49 years):
- •Not breast feeding, non-pregnant (based on negative urine pregnancy test) and no plan to become pregnant during the study period
- •Women who are post-menopausal (until 49 years of age) or not surgically sterile (hysterectomy or tubal ligation) must be willing to use effective contraceptive method to prevent pregnancy after vaccination. Effective methods include intrauterine device, hormonal contraceptives (oral, injectable, patch, implant, ring) or double barrier contraceptives (condom or diaphragm with spermicide).
- •Women with credible history of abstinence may be enrolled at the discretion of the investigator
排除标准
- •Participation in another clinical trial involving any therapy within the previous three months or planned enrolment in such a trial during the period of this study.
- •Hypersensitivity after previous administration of any vaccine.
- •Having a history of lab-confirmed influenza infection within 3 months preceding enrolment to the trial
- •Vaccination against influenza in the past 12 months preceding enrolment to the trial (reviewed by vaccination record at NHSO and oral history)
- •Receipt of any non-study vaccine within four weeks prior to enrolment or refusal to postpone receipt of such vaccines until after the Day 28 visit.
- •Having a health condition placing the potential participant in a risk group recommended for routine influenza vaccination by Advisory Committee on Immunization Practices (ACIP), e.g. chronic pulmonary (including asthma), cardiovascular, renal, hepatic, hematological, or metabolic disorders (including diabetes mellitus); immunosuppressive illness, recent/ongoing receipt of immunosuppressive therapy, or human immunodeficiency virus infection
- •Individuals employed in professions prone to influenza transmission to or from high-risk populations are not eligible to participate e.g. Healthcare workers and poultry cullers (also based on ACIP recommendations)
- •History of anaphylactic or other allergic reactions to influenza vaccine or any vaccine component or excipient (e.g. eggs, gentamicin, or thimerosal)
- •History of Guillain-Barr Syndrome.
- •Having acute infection with fever > 38 degree Celsius and noninfectious diseases (within 72 hours) preceding enrolment in the trial
- •The volunteers who have been taking immunoglobulin products or have had a blood transfusion during past 3 months before the beginning of the trial or planned receipt of such products prior to the Day 28 visit.
- •Current alcohol abuse or drug addiction (high risk level - based on criteria of Department of Mental Health: score of 13 or more) that might interfere with the ability to comply with trial procedures
- •Any condition that in the opinion of the investigator would pose a health risk to the participant if enrolled, or could interfere with the evaluation of the vaccine
研究者
相似试验
已完成
3 期
Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of AgeInfluenza DiseaseNCT01346592Novartis Vaccines6,104
已完成
3 期
A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy ToddlersMeningococcal MeningitisMeaslesMumpsRubellaVaricellaNCT00384397Sanofi Pasteur, a Sanofi Company1,128
已完成
3 期
A Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-naïve SubjectsSmallpoxNCT01144637Bavarian Nordic4,005
已完成
3 期
Safety and Immunogenicity of One Dose of Seasonal Trivalent Influenza Virus Vaccine (TIVf, Purified Surface Antigen, Inactivated, Egg Derived) in Adults Aged 18 Years and AboveHumanInfluenzaNCT01640327Novartis Vaccines126
Unknown
3 期
A Study of a Candidate COVID-19 Vaccine (COV003)CoronavirusNCT04536051University of Oxford10,300