Immunogenicity and Safety of Sanofi Pasteur's AVAXIM 80U Pediatric Vaccine Followed by Booster Dose

Hepatitis A Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00483470
• Other study ID #: HAF78
• Status: Completed
• Phase: Phase 3
• First received: June 5, 2007
• Last updated: January 17, 2014
• Start date: June 2007
• Est. completion date: August 2008

Study information

• Verified date: January 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: August 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 15 Years

Eligibility

Inclusion Criteria :

Inclusion criteria to be checked at the screening visit (SC):

1. Toddlers, children and adolescents:

Sub-Group 1: from 12 months to 3 years of age on the day of inclusion

Sub-Group 2: from 4 to 6 years of age on the day of inclusion

Sub-Group 3: from 7 to 9 years of age on the day of inclusion

Sub-Group 4: from 10 to 12 years of age on the day of inclusion

Sub-Group 5: from 13 to 15 years of age on the day of inclusion

2. 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)

Inclusion criteria to be checked at the inclusion visit (V01):

1. Toddlers, children and adolescents:

Sub-Group 1: from 12 months to 3 years of age on the day of inclusion

Sub-Group 2: from 4 to 6 years of age on the day of inclusion

Sub-Group 3: from 7 to 9 years of age on the day of inclusion

Sub-Group 4: from 10 to 12 years of age on the day of inclusion

Sub-Group 5: from 13 to 15 years of age on the day of inclusion

2. Inclusion informed consent form signed by the parent(s) or other legal representative for all the subjects and by the adolescents (sub-group 5 only)

3. Able to attend all scheduled visits and to comply with all trial procedures

4. Subject anti-HAV seronegative (IgG) according to the screening results (assay performed with local kit)

5. Subject HBsAg seronegative and ALT <40 IU/l according to the screening results

Exclusion Criteria :

Exclusion criteria to be checked at the inclusion visit (V01):

1. Participation in another clinical trial in the 4 weeks preceding trial vaccination

2. Planned participation in another clinical trial during the present trial period

3. Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy

4. 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

5. Chronic illness at a stage that could interfere with trial conduct or completion

6. Blood or blood-derived products received in the past 3 months

7. Any vaccination in the 4 weeks preceding the trial vaccination

8. Any vaccination planned in the 4 weeks following the trial vaccination

9. History of hepatitis A infection (confirmed either clinically or serologically )

10. Previous vaccination against hepatitis A with the trial vaccine or another hepatitis A vaccine

11. Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination

12. History of /current seizures

13. Clinical or serological evidence of systemic illness including Hepatitis C and HIV

14. Febrile (axillary temperature = 37.1°C) or acute illness

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A

Intervention

Biological:
• Hepatitis A vaccine AVAXIM 80U
0.5 mL, Intramuscular
• Hepatitis A vaccine (HAVRIX 720)
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine		1 month post-vaccination	No

External Links

•   Link
•   Link