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

• Conditions: Hepatitis A; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-005191-18-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-19
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 720

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 720
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1) To demonstrate the non-inferiority in terms of seroprotection rate of AVAXIM 80U Pediatric vaccine versus HAVRIX 720 vaccine 1 month after booster vaccination.;Secondary Objective: 1) To describe the immunogenicity of the study vaccines after booster vaccination in both vaccine groups.<br>2) To describe the safety after each injection of the study vaccines.;Primary end point(s): 1) To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine ;Timepoint(s) of evaluation of this end point: 1 month post-vaccination