Safety of Imovax Polio in Chinese Infants and Children
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.
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2005
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 24, 2005
CompletedFirst Posted
Study publicly available on registry
November 28, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedJanuary 22, 2014
January 1, 2014
3 months
November 24, 2005
January 20, 2014
Conditions
Keywords
Study Arms (2)
Group 1
EXPERIMENTALChildren at 18 months of age
Group 2
EXPERIMENTALInfants at 2 months of age
Interventions
0.5 mL, intramuscular (IM)
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Pingle, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Sanofi Pasteur, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2005
First Posted
November 28, 2005
Study Start
November 1, 2005
Primary Completion
February 1, 2006
Study Completion
April 1, 2006
Last Updated
January 22, 2014
Record last verified: 2014-01