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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01838070
First received: April 18, 2013
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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.

Condition Phase
Hepatitis A
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Regulatory Post-Marketing Surveillance (PMS) Study for AVAXIM 160U (Hepatitis A Vaccine)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 600
Study Start Date: April 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study Group
Participants that has received AVAXIM 160U vaccine administered under the routine practice according to Summary of Product Characteristics

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01838070

Contacts
Contact: Public Registry Sanofi Pasteur RegistryContactUs@sanofipasteur.com

Locations
Korea, Republic of
Recruiting
Seoul, Korea, Republic of, 120 752
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur SA
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01838070     History of Changes
Other Study ID Numbers: HAF85, U1111-1127-7211
Study First Received: April 18, 2013
Last Updated: May 6, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Sanofi:
Hepatitis A
Hepatitis A vaccine
AVAXIM 160U

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on August 01, 2014