Immunogenicity and Safety of Imovax Polio in Chinese Infants Compared to Local OPV
NCT ID: NCT00348387
Last Updated: 2014-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
600 participants
INTERVENTIONAL
2006-06-30
2008-12-31
Brief Summary
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The primary objective of this Pase III trial is to compare IMOVAX Polio to the current Chinese standard of care (OPV) that is administered following a schedule of 2-3-4 months. The objective is to demonstrate that after the 3 doses primary series, in terms of seroprotection rates, IMOVAX Polio is not inferior to OPV. The safety of IPV will be assessed after each IPV dose.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group 1
Poliomyelitis Vaccine inactivated
0.5 mL, Intramuscular
Group 2
Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)
1g dragee, oral
Interventions
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Poliomyelitis Vaccine inactivated
0.5 mL, Intramuscular
Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)
1g dragee, oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Days
70 Days
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Guilin, , China
PingLe County, , China
Countries
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Related Links
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Related Info
Other Identifiers
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IPV13
Identifier Type: -
Identifier Source: org_study_id
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