Immunogenicity and Safety of Sanofi Pasteur's AVAXIM 80U Pediatric Vaccine Followed by Booster Dose
1 other identifier
interventional
720
1 country
3
Brief Summary
As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2007
Shorter than P25 for phase_3
3 active sites
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
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 5, 2007
CompletedFirst Posted
Study publicly available on registry
June 7, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedJanuary 22, 2014
January 1, 2014
11 months
June 5, 2007
January 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine
1 month post-vaccination
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
0.5 mL, Intramuscular
Eligibility Criteria
You may qualify if:
- Toddlers, children and adolescents:
- Screening informed consent form signed by the parent(s) or other legal representative for all the subjects and by the adolescents (sub-group 5 only)
- Toddlers, children and adolescents:
- Able to attend all scheduled visits and to comply with all trial procedures
- Subject anti-HAV seronegative (IgG) according to the screening results (assay performed with local kit)
- Subject HBsAg seronegative and ALT \<40 IU/l according to the screening results
You may not qualify if:
- Participation in another clinical trial in the 4 weeks preceding 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 vaccines components or history of a life-threatening reaction to the trial vaccines 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
- Any vaccination in the 4 weeks preceding the trial vaccination
- Any vaccination planned in the 4 weeks following the trial vaccination
- History of hepatitis A infection (confirmed either clinically or serologically )
- Previous vaccination against hepatitis A with the trial vaccine or another hepatitis A vaccine
- Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- History of /current seizures
- Clinical or serological evidence of systemic illness including Hepatitis C and HIV
- Febrile (axillary temperature ≥ 37.1°C) or acute illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
Guilin, Guangxi, 541001, China
Unknown Facility
Nanning, Guangxi, 530021, China
Unknown Facility
Yongfu Country, Guangxi, 541800, China
Related Publications (1)
Yoon SH, Kim HW, Ahn JG, Kim IT, Kim JH, Kong KA, Kim KH. Reappraisal of the Immunogenicity and Safety of Three Hepatitis A Vaccines in Adolescents. J Korean Med Sci. 2016 Jan;31(1):73-9. doi: 10.3346/jkms.2016.31.1.73. Epub 2015 Dec 24.
PMID: 26770041DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2007
First Posted
June 7, 2007
Study Start
June 1, 2007
Primary Completion
May 1, 2008
Study Completion
August 1, 2008
Last Updated
January 22, 2014
Record last verified: 2014-01