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Safety of Two Doses of Avaxim® 80U Pediatric (Inactivated Hepatitis A Vaccine) in Toddlers, Children and Adolescents | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

Safety of Two Doses of Avaxim® 80U Pediatric (Inactivated Hepatitis A Vaccine) Administered 6 Months Apart in Healthy Toddlers, Children and Adolescents Aged 12 Months to 15 Years in China

NCT02011763•Sanofi Pasteur, a Sanofi Company

View on ClinicalTrials.gov

Summary

The aim of this study is to describe the safety profile of Avaxim 80U Pediatric, in order to confirm the good safety profile of the vaccine. Primary objective: * To describe the safety of Avaxim 80U Pediatric after each dose of vaccine administered 6 months apart, in subjects aged 12 months to 15 years.

Detailed Description

Eligible participants aged 12 months to 15 years and 5 months (185 months) at enrollment will receive two doses of vaccine for the prevention of hepatitis A (6 months apart), and will be followed up for safety until 30 days after the second vaccination.

Eligibility

Age

1 - 15 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Aged 12 to 185 months (approximately 15 years and 5 months) on the day of inclusion
•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
•Subject and parent / legally acceptable representative are able to attend all schedule visits and to comply with all trial procedures
•Subjects aged less than 2 years only: Born at full term of pregnancy (≥ 37 weeks) and/or with a birth weight ≥ 2.5 kg.

Exclusion Criteria

•Subject is pregnant, or lactating, or of 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)
•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
•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
•Previous vaccination against Hepatitis A with either the trial vaccine or another Hepatitis A vaccine
•Receipt of immune globulins, blood or blood-derived products in the past 3 months
•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)
•History of Hepatitis A infection, confirmed either clinically, serologically, or microbiologically
•At high risk for hepatitis A infection during the trial
•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
•Self-reported thrombocytopenia, contraindicating intramuscular vaccination
+6 more criteria

Locations (1)

Beijing, China

Key Dates

Start Date

December 1, 2013

Primary Completion Date

September 1, 2014

Completion Date

August 1, 2015

Last Updated

October 1, 2015

Enrollment

355

ACTUAL participants

Conditions

Hepatitis AHepatitis A Virus

Interventions

Avaxim 80U Pediatric: Inactivated Hepatitis A Virus

BIOLOGICAL

Long-term Immunogenicity of L-HAV Vaccine Among Healthy Thai Children and Adolescents

NCT07032610

Hepatitis AHepatitis A Virus+1 more

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COMPLETEDPHASE4

Effectiveness of Booster With 1 or 2 Doses of HAV Vaccine Among HIV-infected Patients

NCT03855176

Hepatitis AHuman Immunodeficiency Virus+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 1, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Long-term Immunogenicity of L-HAV Vaccine Among Healthy Thai Children and Adolescents

Effectiveness of Booster With 1 or 2 Doses of HAV Vaccine Among HIV-infected Patients

What is the Anti-HAV Seroprevalence of Travelers >60 Years or Having Lived in a Tropical Country for >5 Years

A Study to Compare the Efficacy of Hepatitis A Vaccine and Immune Globulin When Given After Exposure to Hepatitis A

Comparison of Immunization Schedules of Inactivated Hepatitis A Vaccine and Combined Hepatitis A and Hepatitis B Vaccine

Safety and Immunogenicity of Measles Vaccine, Varicella Vaccine and Hepatitis-A Vaccine