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CompletedNCT00483470Updated Jan 22, 2014

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

A Phase 3 interventional study of Hepatitis A vaccine AVAXIM 80U and Hepatitis A vaccine (HAVRIX 720) in Hepatitis A, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 3 sites in China. Open to participants aged 12 Months to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-22.

Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
720
Allocation
Randomized
Ages
12 Months to 15 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Hepatitis A

Keywords

  • Hepatitis A
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 720 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 studies on the registry; 4 are open to participants now.

Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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 :

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
720 participants (actual)

Study arms

  • Experimental
    1

    Biological: Hepatitis A vaccine AVAXIM 80U

  • Active comparator
    2

    Biological: Hepatitis A vaccine (HAVRIX 720)

Interventions

  • BiologicalHepatitis A vaccine AVAXIM 80U

    0.5 mL, Intramuscular

    Also known as: AVAXIM 80U Pediatric vaccine

  • BiologicalHepatitis A vaccine (HAVRIX 720)

    0.5 mL, Intramuscular

06

What researchers measure

Primary outcomes

  1. To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine

    Time frame: 1 month post-vaccination

07

Study locations

3 sites
  • Guilin City, Guangxi 541001, China
  • Nanning, Guangxi 530021, China
  • Yongfu Country, Guangxi 541800, China
08

References and documents

Publications

  • 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. PubMed 26770041 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00483470
Lead sponsor
Sanofi Pasteur, a Sanofi Company
Responsible party
Sponsor
First posted
Jun 7, 2007
Start date
Jun 2007
Primary completion
May 2008
Completion
Aug 2008
Last update
Jan 22, 2014

Study contacts

Medical Director
study director · Sanofi Pasteur Inc
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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