Safety of Two Doses of Avaxim 80U Pediatric (Inactivated Hepatitis A vaccine) in Toddlers, Children and Adolescents

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 355

Inclusion Criteria

An individual had to fulfill all of the following criteria in order to be eligible for trial enrollment:
1) Aged 12 to 185 months (approximately 15 years and 5 months) on the day of inclusion
2) Informed consent form has been signed and dated by the subject aged 12 years old and above (based on local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative
3) Subject and parent/legally acceptable representative are able to attend all schedule visits and to comply with all trial procedures
4) Subjects aged less than 2 years only: Born at fu ll term of pregnancy (= 37 weeks) and/or with a birth weight = 2.5 kg.
Are the trial subjects under 18? yes
Number of subjects for this age range: 355
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

An individual fulfilling any of the following criteria was to be excluded from trial enrollment:
1) Subject is pregnant, or lactating, or o f childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination)
2) Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
3) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination
4) Previous vaccination against Hepatitis A with either the trial vaccine or another Hepatitis A vaccine
5) Receipt of immune globulins, blood or blood-derived products in the past 3 months
6) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy
(prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
7) History of Hepatitis A infection, confirmed either clinically, serologically, or microbiologically
8) At high risk for Hepatitis A infection during the trial
9) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
10) Self-reported thrombocytopenia, contraindicating IM vaccination
11) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
12) Deprived of freedom by an administrative or court order, o r in an emergency setting, or hospitalized involuntarily
13) Current alcohol abuse or drug addiction
14) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
15) Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature = 37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
16) Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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