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

NCT02011763 | Completed Phase 4

• 2 other identifiers: HAF87U1111-1127-7652
• Study Type: interventional
• Target: 355
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis A; Hepatitis A Virus

Keywords

Hepatitis A; hepatitis A virus; Avaxim® 80U Pediatric

Outcome Measures

Primary Outcomes (1)

• Number of participants reporting solicited injection site and systemic events and unsolicited adverse events following vaccination with Avaxim® 80U Pediatric (Inactivated Hepatitis A vaccine).

  Participants aged ≤ 23 months, Solicited injection site reactions: Tenderness, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Participants 2 to 15 Years of Age: Solicited injection site reactions: Pain, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia. Unsolicited adverse events, including serious adverse events will also be collected for all participants

  Day 0 up to Day 30 post vaccination

Study Arms (1)

Study Group

EXPERIMENTAL

Toddlers, children and adolescents aged 12 months to 15 years

Biological: Avaxim 80U Pediatric: Inactivated Hepatitis A Virus

Interventions

Avaxim 80U Pediatric: Inactivated Hepatitis A Virus BIOLOGICAL

0.5 mL, Intramuscular (2 injection 6 months apart)

Also known as: Avaxim 80U Pediatric

Study Group

Eligibility Criteria

• Age: 12 Months - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• Current alcohol abuse or drug addiction
• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
• 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
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Unknown Facility

Beijing, 100021, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Hepatitis A; Hepatitis

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Liver Diseases; Digestive System Diseases

Study Officials

• Medical Director

  Sanofi Pasteur SA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 13, 2013
• Study Start: December 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: August 1, 2015
• Last Updated: October 1, 2015

Record last verified: 2015-09

Locations

CN (1)