- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00258843
Safety of Imovax Polio in Chinese Infants and Children
January 20, 2014 updated by: Sanofi Pasteur, a Sanofi Company
Clinical Safety Evaluation Study of the Sanofi Pasteur's Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) Administered as a Single Booster Dose at 18 Months of Age in Healthy Chinese Children, and as the First Dose of Primary Vaccination at 2 Months of Age in Healthy Chinese Infants.
To describe the tolerance in terms of occurrence of serious adverse reactions and severe adverse reactions (injection site and systemic) within eight days after one dose of IMOVAX Polio™ administered in children and infants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pingle, China
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 months to 1 year (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Group 1: Aged 18 months (18-20 months) on the day of inclusion
- Group 2: Aged 2 months (56-70 days) on the day of inclusion
Exclusion Criteria:
- Participation in another clinical trial in the 4 weeks preceding the trial vaccination
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
Children at 18 months of age
|
0.5 mL, intramuscular (IM)
Other Names:
0.5 mL, IM
Other Names:
|
Experimental: Group 2
Infants at 2 months of age
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0.5 mL, intramuscular (IM)
Other Names:
0.5 mL, IM
Other Names:
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (Actual)
February 1, 2006
Study Completion (Actual)
April 1, 2006
Study Registration Dates
First Submitted
November 24, 2005
First Submitted That Met QC Criteria
November 24, 2005
First Posted (Estimate)
November 28, 2005
Study Record Updates
Last Update Posted (Estimate)
January 22, 2014
Last Update Submitted That Met QC Criteria
January 20, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Neuromuscular Diseases
- Central Nervous System Infections
- Enterovirus Infections
- Picornaviridae Infections
- Spinal Cord Diseases
- Myelitis
- Poliomyelitis
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- IPV17
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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