Phase I/II Safety and Immunogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1) in Healthy Thais
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 363
- 试验地点
- 2
- 主要终点
- Systemic reaction and local reaction (vital sign, temperature)
研究概览
简要总结
The purpose of this study is to evaluate safety and reactogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) manufactured by GPO, Thailand, and to evaluate humoral immune response of the above vaccine after intranasal application by using HAI test, micro neutralization assays.
详细描述
Part A: 24 volunteers will be enrolled and divided into 2 groups -12 volunteers in each of 2 groups receiving either 5.0-6.5 log 10 EID50 or 6.6-7.5 log10 EID50 respectively. 9 who will received vaccine vaccine strain and 3 who will received placebo.
Part B: Total 324 participants will randomized into 2 group using 3:1 ratio (300 vaccines:100 placebos). There are 3 stratified age groups: >12-18 years, >18-49 years and >49 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 9 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 9 - >49 years old
- •Having Thai ID card or equivalent
- •Are seronegative to the specific H1N1 influenza virus determined by antibody titer less than 1:10 by HAI test to the corresponding antigen
- •Anti HIV - Negative
- •All hematology & biochemistry within normal range
- •Able to read and write and sign written informed consent
排除标准
- •Known history of egg allergy
- •Having had recently influenza infection confirmed as H1N1 (indeed all other types if Influenza and vaccination with seasonal vaccine will not interfere)
- •History of bronchial asthma
- •History of chronic lung diseases
- •History of chronic rhinitis
- •History of immunodeficiency state
- •History of immunosuppression
- •Acute infectious and noninfectious diseases (within 2 weeks)
- •Exacerbation of chronic diseases or cancer or HIV positives
- •Anamnestic leukocytosis, hepatitis B and C positives
- •The volunteers who have been taking immunoglobulin products or have had a blood transfusion during past three months before the beginning of the experiment
- •Participation in other research study
- •Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding
- •Any concomitant medication with Aspirin
结局指标
主要结局
Systemic reaction and local reaction (vital sign, temperature)
时间窗: 11/2 year
次要结局
- Humoral immune response(11/2 year)
研究者
Punnee Pitisuttithum
Professor
Mahidol University