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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Hepatitis A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Hepatitis A vaccine AVAXIM 80U

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular

2

Group Type ACTIVE_COMPARATOR

Hepatitis A vaccine (HAVRIX 720)

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular

Interventions

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Hepatitis A vaccine AVAXIM 80U

0.5 mL, Intramuscular

Intervention Type BIOLOGICAL

Hepatitis A vaccine (HAVRIX 720)

0.5 mL, Intramuscular

Intervention Type BIOLOGICAL

Other Intervention Names

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AVAXIM 80U Pediatric vaccine

Eligibility Criteria

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Inclusion Criteria

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)

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

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

Minimum Eligible Age

12 Months

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes