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
40 participants
INTERVENTIONAL
2005-11-30
2006-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Group 1
Children at 18 months of age
Inactivated Poliomyelitis vaccine
0.5 mL, intramuscular (IM)
Group 2
Infants at 2 months of age
Inactivated Poliomyelitis vaccine
0.5 mL, IM
Interventions
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Inactivated Poliomyelitis vaccine
0.5 mL, intramuscular (IM)
Inactivated Poliomyelitis vaccine
0.5 mL, IM
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Group 2: Aged 2 months (56-70 days) on the day of inclusion
Exclusion Criteria
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
* Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
* Chronic illness at a stage that could interfere with trial conduct or completion
* Blood or blood-derived products received in the past 3 months (for Group 1) or since birth (for Group 2)
* Any vaccination in the 4 weeks preceding the trial vaccination (except BCG and Hepatitis B \[Hep B\] for Group 2)
* Vaccination planned in the 4 weeks following the trial vaccination
* Group 1: Previous booster vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine.
* Group 2: Previous vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine.
* History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
* Clinical or serological evidence of systemic illness including Hepatitis B, C and HIV
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
* History of/current seizures
* Febrile illness (axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion
2 Months
18 Months
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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Clinical Trials
Role: STUDY_DIRECTOR
Sanofi Pasteur, a Sanofi Company
Locations
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Pingle, , China
Countries
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Related Links
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Related Info
Other Identifiers
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IPV17
Identifier Type: -
Identifier Source: org_study_id
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