Immunogenicity and Safety of the Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) Administered at 2, 3, and 4 Months of Age and Followed by a Booster Dose at 18 Months of age in Healthy Infants in China, versus Commercially Available Oral Poliomyelitis Vaccine

Sanofi Pasteur SA0 个研究点目标入组 600 人开始时间: 2015年11月17日最近更新: 2015年12月7日

适应症

试验速览

暂无简介。

•- Aged 2 months (60-70 days) on the day of inclusion into the study
•- Born at full term pregnancy ( over 36 weeks) with a birth weight = 2.5 kg 2Ibs) or more
•- Parent(s) or legal representative able to understand and give authorization and sign informed consent for participation
•- Able to attend all planned clinic appointment and obey and follow all study instructions
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 600
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Taking part in another clinical trial during the 4 weeks before the first trial vaccination
•- Have plans to take part in another clinical trial d during this trial period
•- Inborn or acquired decreased body natural defense, undertaking treatment that can reduce body's natural defense such as cancer drugs, radiation in the past six months or long term corticosteroid treatment
•- Systemic reaction to any vaccine component or history of life-threatening reaction to study vaccine or any vaccine with the same ingredient(s)
•- Prolonged or long time illness that could interfere with study or full participation
•- Received blood or blood-derived products since birth
•- Received any vaccine in the 4 weeks before the first trial vaccination is given (except BCG and hepatitis B)
•- Have plans to receive any vaccine in the 4 weeks after the (or any) study vaccination is given (except DTacP)
•- Previous vaccination against the poliomyelitis infection with the trial vaccine or another vaccine
•- History of poliomyelitis infection (confirmed either by symptoms, blood or other laboratory test)
•- Clinical or serological evidence of systemic illness including hepatitis B, hepatitis C or Human immunodeficiency virus (HIV)
•- Bleeding disorder or a low platelet which do not allow vaccination into the muscle
•- Had seizures in the past
•- Febrile illness (axillary temperature = 37.1°C) or acute illness on the day of inclusion

发起方

Sanofi Pasteur SA