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

Sponsor

Sanofi Pasteur, a Sanofi Company (Industry)

Overall Status

Completed

CT.gov ID

NCT01838070

Collaborator

(none)

614

Enrollment

Location

Duration (Months)

16.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Hepatitis A

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 Design

Study Type:

Observational

Actual Enrollment :

614 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Safety profile in terms of solicited and unsolicited adverse events following the administration of AVAXIM 160U vaccine [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1		Seoul		Korea, Republic of	120 752

Sponsors and Collaborators

Sanofi Pasteur, a Sanofi Company

Investigators

Study Director: Medical Director, Sanofi Pasteur SA

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Sanofi Pasteur, a Sanofi Company

ClinicalTrials.gov Identifier:

NCT01838070

Other Study ID Numbers:

HAF85
U1111-1127-7211

First Posted:

Apr 23, 2013

Last Update Posted:

Jul 26, 2016

Last Verified:

Jul 1, 2016

Keywords provided by Sanofi Pasteur, a Sanofi Company

Hepatitis A

Hepatitis A vaccine

AVAXIM 160U

Additional relevant MeSH terms:

Hepatitis A

Hepatitis

Study Results

No Results Posted as of Jul 26, 2016