Status:
COMPLETED
Immunogenicity and Safety of Imovax Polio in Chinese Infants Compared to Local OPV
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Poliomyelitis
Polio
Eligibility:
All Genders
60-70 years
Phase:
PHASE3
Brief Summary
This study is intended to support the registration of IMOVAX Polio in China. The primary objective of this Pase III trial is to compare IMOVAX Polio to the current Chinese standard of care (OPV) that...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00348387
Start Date
June 1 2006
End Date
December 1 2008
Last Update
January 22 2014
Active Locations (2)
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1
Guilin, China, 541001
2
PingLe County, China, 542400