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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00483470

Enrollment

720

Registered

2007-06-07

Start date

2007-06-30

Completion date

2008-08-31

Last updated

2014-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis A

Keywords

Hepatitis A

Brief summary

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

Interventions

BIOLOGICALHepatitis A vaccine AVAXIM 80U

0.5 mL, Intramuscular

BIOLOGICALHepatitis A vaccine (HAVRIX 720)

0.5 mL, Intramuscular

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Months to 15 Years

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

Design outcomes

Primary

Measure	Time frame
To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine	1 month post-vaccination

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026