Immunogenicity and Safety of Imovax Polio in Chinese Infants Compared to Local OPV
Poliomyelitis, Polio
About this trial
This is an interventional prevention trial for Poliomyelitis focused on measuring Imovax polio, poliomyelitis
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Group 1
Group 2