NCT02723812已完成4 期
A Bridging Study to Evaluate Safety of GCFLU® One Dose (0.5ml) (Seasonal Influenza Vaccine) Administered Intramuscularly in Healthy Vietnamese Volunteer Aged From 3 Years Old
Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Safety of GCFLU® by assessing the frequency, rate and severity of adverse events (local and general).
研究概览
简要总结
An open label, non-comparative bridging study to evaluate the safety of GCFLU® (seasonal influenza vaccine) administered intramuscularly in healthy Vietnamese volunteer aged from 3 years old
详细描述
A bridging study to evaluate safety of seasonal influenza vaccine GCFLU® pre-filled syringe inj. One dose (0.5 ml) after exposure administered intramuscularly. The study conducted in Ben Luc District of Long An province, in which 120 healthy Vietnamese volunteer aged from 5 year old will be enroll to the study. All subject will receive only one dose (0.5 ml) vaccine in Day 0.
Study variables will be collected to determine and provide the evidence for the safety of GCFLU®, include:
- Local and systemic adverse event (AE) in 30 minutes after vaccination.
- Local and systemic AE in 7 days after vaccination
- Unsolicited AE over 21 days after vaccination.
- Serious adverse event (SAE) after vaccination and in 21 days of observation periods Study protocol has been reviewed and approved by Pasteur Institute in Ho Chi Minh City (HCMC) Institutional Review Board (IRB), Vietnam Ministry of Health - Independent Ethics Committee (IEC) and Vietnam Minister of Health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must meet all criteria below to participate in study
- •A person who is a 3-year-old or older, healthy and can be followed up for 21 days
- •Subject who gave voluntary written consent to participate in the study, and able to comply with the study requirements. With subjects aged from 3 years to below 18 years, parents/legal representative will give voluntary consent to participate in this study, and subjects from 12 to under 18 years old will give voluntary written consent for children.
排除标准
- •Subject have one of criteria below must not participate in study
- •Subject with a known hypersensitivity or allergic reaction to eggs or eggs products, to chicken or chicken products, to any component of the study vaccine, neomycin or gentamicin.
- •Subjects with immune system disorder including immune deficiency disease.
- •Subjects with a history of Guillain-Barre syndrome.
- •Subjects with severe chronic disease (e.g.; cardiovascular disease except for controlled hypertension, respiratory disease, metabolic disease, renal/kidney dysfunction or hemoglobinopathy etc.) who in the investigator's opinion may have a difficulty in participating in the study.
- •Subjects with hemophilia or receiving a treatment with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection.
- •Subject who had acute fever with body temperature exceeding 37.50 Celsius (armpit calculated) before vaccination with the study drug.
- •Subjects who had received other vaccination within 14 days before vaccination with the study drug, or those who had another vaccination scheduled during the study.
- •Pregnant women, breast-feeding women or women of childbearing potential who do not use an appropriate method of contraception (use of condom, intrauterine contraceptive device, or hormone contraceptives, or of a male partner had vasectomy).
- •Subjects who had participated in other clinical study within 28 days priors to vaccination with the study drug, or those who had another clinical trial scheduled during the study.
研究组 & 干预措施
GCFLU® Influenza vaccine (Split virion, Inactivated)
Experimental
One dose 0.5 mL vaccine GCFLU® administered intramuscularly.
干预措施: GCFLU® Influenza vaccine (Split virion, Inactivated) (Biological)
结局指标
主要结局
Safety of GCFLU® by assessing the frequency, rate and severity of adverse events (local and general).
时间窗: 30 minutes after vaccination.
Safety of GCFLU® by assessing the frequency, rate and severity of solicited adverse events (local and general)
时间窗: For 7 days after vaccination.
Safety of GCFLU® by assessing the frequency, rate and severity of unsolicited adverse events.
时间窗: During 21 days after vaccination.
Safety of GCFLU® by assessing the frequency, rate and severity of serious adverse events.
时间窗: During 21 days after vaccination.
次要结局
未报告次要终点
研究者
Nguyen Vu Thuong
Vice Director
Pasteur Institute, Ho Chi Minh City
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
An open-label study to evaluate the safety and efficacy of IMATINIB with chemotherapy in pediatric patients with Ph+/BCR-ABL+ acute lymphoblastic leukemia (Ph+ALL)Children and adolescents aged 1-17 years at diagnosis, with Ph+ALLMedDRA version: 14.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaSystem Organ Class: 100000004864EUCTR2004-001647-30-ITA.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA550
已完成
不适用
A clinical study to test the safety and the efficacy of a single-pill combination of 2 antihypertensive and 1 lipid-lowering drug in patients already well treated with the concomitant administration of the same three drugs on separate tabletsHypertension and dyslipidemiaCirculatory SystemISRCTN27159806Institut de Recherche Internationales Servier130
进行中（未招募）
1 期
Patisiran-LNP in Patients with hATTR Amyloidosis Disease Progression Post-Liver TransplantHereditary Transthyretin-mediated Amyloidosis (hATTR amyloidosis)MedDRA version: 20.0Level: PTClassification code 10007509Term: Cardiac amyloidosisSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10019889Term: Hereditary neuropathic amyloidosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2018-003519-24-DEAlnylam Pharmaceuticals, Inc.20
进行中（未招募）
1 期
Patisiran-LNP in Patients with hATTR Amyloidosis Disease Progression Post-Liver TransplantHereditary Transthyretin-mediated Amyloidosis (hATTR amyloidosis)MedDRA version: 20.0Level: PTClassification code 10007509Term: Cardiac amyloidosisSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10019889Term: Hereditary neuropathic amyloidosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2018-003519-24-ITALNYLAM PHARMACEUTICALS, INC.20
进行中（未招募）
1 期
Patisiran-LNP in Patients with hATTR Amyloidosis Disease Progression Post-Liver TransplantHereditary Transthyretin-mediated Amyloidosis (hATTR amyloidosis)MedDRA version: 20.0Level: PTClassification code 10007509Term: Cardiac amyloidosisSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 20.0Level: PTClassification code 10019889Term: Hereditary neuropathic amyloidosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2018-003519-24-FRAlnylam Pharmaceuticals, Inc.20