Regulatory Post-Marketing Surveillance Study for Hepatiti... | NCT01838070

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

NCT01838070

Sponsor

Sanofi Pasteur, a Sanofi Company

Status

Completed

Last Update Posted

Jul 26, 2016Estimated

Enrollment

614Actual

Phase

Not provided

Conditions

Hepatitis A

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1127-7211	Other Identifier	WHO

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Nov 2015Actual

Completion Date

May 2016Actual

First Submitted Date

Apr 18, 2013

First Submission Date that Met QC Criteria

Apr 22, 2013

First Posted Date

Apr 23, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2016

Last Update Posted Date

Jul 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

614Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group		Participants that has received AVAXIM 160U vaccine administered under the routine practice according to Summary of Product Characteristics

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety profile in terms of solicited and unsolicited adverse events following the administration of AVAXIM 160U vaccine	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Medical Director	Sanofi Pasteur SA	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30673992	Derived	Kim H, Oh Y, Thollot Y, Bravo C. Post-Marketing Surveillance of Hepatitis A Virus Vaccine (Avaxim(R) 160U) in South Korea from 2011 to 2015. Infect Dis Ther. 2019 Mar;8(1):105-112. doi: 10.1007/s40121-019-0230-9. Epub 2019 Jan 23.

ID	Term
D006525	Hepatitis, Viral, Human
D014777	Virus Diseases
D007239	Infections
D004769	Enterovirus Infections