Regulatory Post-Marketing Surveillance Study for Hepatitis A Vaccine (AVAXIM 160U)

July 25, 2016 updated by: Sanofi Pasteur, a Sanofi Company

Regulatory Post-Marketing Surveillance (PMS) Study for AVAXIM 160U (Hepatitis A Vaccine)

This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) "Basic standard for reexamination of new drug".

Primary objective:

  • To assess the safety of AVAXIM 160U (Hepatitis A vaccine) administered under the routine practice, according to Korea Food and Drug Administration "Basic standard for reexamination of new drug" based on the pharmaceutical law in Korea.

Study Overview

Status

Completed

Conditions

Detailed Description

The study will be conducted under the real clinical practices in accordance with Korea Food and Drug Administration "Basic standard for reexamination of new drug".

No vaccine will be provided and/or administered as part of this protocol, however only participants that has received AVAXIM 160U vaccine administered under the routine practice according to Summary of Product Characteristics will be part of the surveillance.

Study Type

Observational

Enrollment (Actual)

614

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who have received AVAXIM 160U (Hepatitis A Vaccine) according to Summary of Product Characteristics (SmPC)

Description

Inclusion Criteria:

  • Subjects aged 16 years and older
  • Informed consent signed by the subject and by parent or legal representative for subject aged 16 to 19 years
  • Informed consent sign by subject for subject aged of 20 year of age and older
  • Receipt of AVAXIM 160U according to Summary of Product Characteristics (SmPC).

Exclusion Criteria:

  • Contraindications to vaccination according to AVAXIM 160U Summary of Product Characteristics (SmPC)
  • Subject is known to be pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence for at least 4 weeks prior to the vaccination until at least 4 weeks after)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Study Group
Participants that has received AVAXIM 160U vaccine administered under the routine practice according to Summary of Product Characteristics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety profile in terms of solicited and unsolicited adverse events following the administration of AVAXIM 160U vaccine
Time Frame: Day 0 up to 30 Days post-vaccination
Solicited injection site: Pain, Erythema, and Swelling: Solicited Systemic Reactions: Fever (temperature), headache, and myalgia. Unsolicited averse events including non serious and serious adverse events.
Day 0 up to 30 Days post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

April 18, 2013

First Submitted That Met QC Criteria

April 22, 2013

First Posted (Estimate)

April 23, 2013

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAF85
  • U1111-1127-7211 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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