NCT01123954已完成2 期
Evaluating the Safeness of Trivalent Subunit Inactivated Influenza Vaccines in Preventing Flu on Vietnamese Volunteers
Novartis Vaccines1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2010年1月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Using the single vaccination for volunteers and follow up within 30 days since the first vaccination to evaluate levels of safety (AEs) after vaccination
研究概览
简要总结
The present study will evaluate the safety in healthy people aged 1- 45 years (male and female) after single intramuscular (IM) dose of trivalent subunit inactivated influenza vaccine till the 30-days follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy people with aged 1 to 45 years;
- •Previous history of not being vaccinated by any flu vaccines;
- •Women of childbearing potential agree to apply the contraceptive measures during the study period;
- •Do not have any acute or chronic diseases by screening;
- •Having the abilities of understanding and conforming the study plan;
- •Volunteer to the study;
- •Agree to vaccinate completely and conform the follow up procedure within 30 days after the first vaccination.
排除标准
- •Having the suspected symptoms of infecting flu: cough, sore throat, stuffy or running nose, headache, malaise, myalgia and arthralgia, weakness, chilly or sweat;
- •A prior history of allergy to any components of candidate vaccine;
- •Sensitive to eggs or chicken protein, kanamycin, neomycin sulphate, formaldehyde, cetyltrimethylammonium bromide (CTAB) and polysorbate 80;
- •Females who are pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who are sexually active and have not used or do not plan to use acceptable birth control measures during the first 3 weeks after vaccination;
- •Being immuno deficiency due to treatment;
- •Using immunosuppressive drugs (belong to steroid group) within 06 months before vaccination;
- •Being sickness or cancer or HIV (+);
- •Participating in other study on drug or vaccination;
- •Receipt of other vaccine within 04 weeks before participating in the study;
- •Congenital malformation, mental disorder or members of family having the mental disorder;
- •Using immune globulin or blood products within 03 months before vaccination;
- •Having an acute or chronic diseases that can cause influence on the safety including: hepatic, renal, mental diseases or diabetes and transplantation;
- •Body temperature over 37.5 degree Celcius within 01 week before vaccination;
- •History of alcohol or drugs addicted within 05 years;
- •Planning to travel away from the study site among the visits.
结局指标
主要结局
Using the single vaccination for volunteers and follow up within 30 days since the first vaccination to evaluate levels of safety (AEs) after vaccination
时间窗: 30 days, including the follow-up period
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety, Tolerability and Immunogenicity Study of 2 Dose Levels of Trimeric Glycoprotein140 (gp140) in Healthy Adult VolunteersHealthyNCT02304185Crucell Holland BV50
已完成
3 期
A Study of V110 a Pneumococcal Vaccine in Healthy Adults (V110-013)HealthyPneumococcal InfectionsNCT00127153Merck Sharp & Dohme LLC130
已完成
1 期
Clinical Trial of Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris)Acute GastroenteritisNCT04563533Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.580
已完成
1 期
A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333HCV InfectionNCT00768690Abbott45
已完成
1 期
A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072 Used to Treat Hepatitis CHCV InfectionNCT00890318Abbott32