INDICATION & USAGE

IXIARO is a vaccine indicated for the prevention of disease caused by Japanese encephalitis virus, approved for use in individuals 2 months of age and older.

Important Safety Information

Severe allergic reaction after a previous dose of IXIARO, any other Japanese encephalitis vaccine,  or any component of IXIARO, including protamine sulfate a compound known to cause hypersensitivity reactions in some individuals is a contraindication to administration of IXIARO.  Individuals with a history of severe allergic reaction to another Japanese encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO is considered.

Vaccination with IXIARO may not protect all individuals.  Individuals with a weakened immune system may have a diminished immune response to IXIARO.  Fainting may occur when receiving any injection, including IXIARO.  Tell your healthcare practitioner if you have a history of fainting from injections.

The most common (>10%) adverse reactions were: fever, irritability, diarrhea, and injection site redness in infants 2 months to <1 year of age; fever in children 1 to <12 years of age; pain and tenderness in adolescents 12 to <18 years of age; and, headache, muscle pain, and injection site pain and tenderness in adults.

You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967.  You should ask your healthcare practitioner for medical advice about adverse events.

For more information, please see the physician’s Prescribing Information and ask your healthcare practitioner about the risk and benefits of IXIARO.

    

INDICATION & USAGE

IXIARO is a vaccine indicated for the prevention of disease caused by Japanese encephalitis virus, approved for use in individuals 2 months of age and older.

Important Safety Information

Severe allergic reaction after a previous dose of IXIARO, any other Japanese encephalitis vaccine,  or any component of IXIARO, including protamine sulfate  a compound known to cause hypersensitivity reactions in some individuals  is a contraindication to administration of IXIARO.  Individuals with a history of severe allergic reaction to another Japanese encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO is considered.

Vaccination with IXIARO may not protect all individuals.  Individuals with a weakened immune system may have a diminished immune response to IXIARO.  Fainting may occur when receiving any injection, including IXIARO.  Tell your healthcare practitioner if you have a history of fainting from injections.

The most common (>10%) adverse reactions were: fever, irritability, diarrhea, and injection site redness in infants 2 months to <1 year of age; fever in children 1 to <12 years of age; pain and tenderness in adolescents 12 to <18 years of age; and, headache, muscle pain, and injection site pain and tenderness in adults.

You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967.  You should ask your healthcare practitioner for medical advice about adverse events.

For more information, please see the physician’s Prescribing Information and ask your healthcare practitioner about the risk and benefits of IXIARO.

    

 

 

Privacy Policy

 

Valneva USA Inc. (“Valneva” or “we”) has created this privacy policy (“Privacy Policy”) in order to demonstrate our firm commitment to privacy.  The following discloses our information gathering and use practices for the www.valneva.us Website and other web pages or online services owned by Valneva or one of its affiliated corporations and which link to or refer to the present Privacy Policy (collectively referred to as the “Site”).

The present policy governs your access and use of the Site and serves to inform you of our practices pertaining to the collection, use and disclosure of information that you may provide, whether intentionally or unintentionally, by your use of the Site.

IT IS THUS IMPORTANT THAT YOU CAREFULLY READ AND FULLY UNDERSTAND THE ENTIRE PRIVACY POLICY PRIOR TO USING THE SITE.  By using the Site, you are consenting to the practices described in this Privacy Policy.

 

  1. Personal Information Collection

The Sites may collect information from health care providers and other visitors both by asking you specific questions and by permitting you to communicate directly with us via email and/or feedback forms.  Some of the information that you submit on the Site may be personal information.  We also may collect personal information when you provide it to us voluntarily or in other circumstances with your consent or as permitted or required by law.  For example, we may collect your personal information when you:

request information;

inquire or provide comments about our products and services;

participate in contests or other promotions;

fill out questionnaires or surveys;

submit your resume or other personal information in connection with employment possibilities with us; or

otherwise provide your personal information to us, including by telephone, mail, email, facsimile or through the Site.

The information we may collect includes: personal and business contact information, such as name, title, address, telephone and fax number, gender, and email address or any other information of similar nature and other information with your consent or as permitted or required by law.

In addition, we may receive information about you from publicly and commercially available sources, as permitted by law, which we may combine with other information we receive from or about you.

Calls to and from Valneva may be recorded and/or monitored for quality and training purposes. Recordings may also be used to help us develop and improve our products and services.  Information may also be actively and passively collected by our web sites.  See Our Web Sites below for details.

As you navigate through the Site, certain information can be passively collected (that is, gathered without your actively providing the information) using various technologies and means, such as Internet Protocol addresses and cookies and other tracking technologies, as described further below.  Your Internet browser automatically transmits to the Site some of this anonymous information, such as the URL of the web site you just came from and the Internet Protocol address and the browser version your computer is currently using.

  1. Purposes

To Provide and Manage the Services You Request.  If you provide us with personal information, we will retain and use that information to provide you with the products or services you use or request.  We may also use personal information to analyze, improve, and customize your experience with our products and services, including the Site.

 

To Contact You.  We may use your personal information to respond to questions that you may submit to us via the Site or to communicate with you about our products, services, and promotions, such as company announcements and health and product related information.  If you provide a resume to us through the Site, we may retain your resume in our files in order to contact you for current or future job openings.

To Better Understand Our Users.  We may use information we gather to determine which areas of the Site are most frequently visited to understand how to enhance the Site.

  1. Disclosures

Valneva may disclose your personal information in the following circumstances:

We may disclose your information within our family of affiliated companies.

We may disclose your information to agents and service providers that are performing services on our behalf, for example: mailing, marketing, information technology and/or data hosting or processing services, or similar services, or otherwise to collect, use, disclose, store or process personal information on our behalf for the purposes described in this Privacy Policy.

We may disclose personal information when required in order to meet legal, regulatory, industry self-regulatory, insurance, audit, security or ethical requirements, including obligations to health and drug regulatory and self-regulatory bodies, physicians, hospitals, or other health care facilities, and when we have reason to believe that disclosing information is necessary to protect our or others’ rights or property.

Your personal information may be used by Valneva and disclosed to parties connected with the contemplated or actual financing, insuring, sale, transfer assignment or other disposal of all or part of Valneva’s business or assets.

We also may disclose your personal information to third parties, where otherwise required by applicable laws, court orders, or government regulations.

We may also disclose your personal information with your consent.

  1. Security

We take reasonable steps to protect your personal information using physical, electronic, or procedural security measures.  Although we have enacted security measures, we cannot guarantee the security of any information that you submit via email or over the Internet. Submission of personal information using such networks is done at your own risk, since no Internet transmission is ever 100% secure or error-free (for example, emails sent to or from our web sites may not be secure). You should take special care in deciding what information you send to us via email or posting on our web sites.

  1. Links to other websites

The Site may contain links or references to other web sites to which this Privacy Policy does not apply.  Valneva is not responsible for the data collection and use practices of companies or organizations to which the Site may provide links, and our Privacy Policy and Terms and Conditions do not apply to such linked websites.  We encourage you to read the privacy statement/policy of every web site you visit.

  1. Online Tracking

The Sites use standard Internet technologies, such as cookies, Internet tags, web beacons, Local Shared Objects, and other tools.

Generally speaking, a “cookie” is a bit of information that a web site sends to your web browser that helps the site remember information about you and your preferences.

“Session” cookies are temporary bits of information that are used to improve navigation, block visitors from providing information where inappropriate and collect aggregate statistical information on the site.  They are erased once you exit your web browser or otherwise turn off your computer.

“Persistent” cookies are more permanent bits of information that are placed on the hard drive of your computer and stay there unless you delete the cookie.  Persistent cookies store information on your computer for a number of purposes, such as retrieving certain information you have previously provided (such as passwords), helping to determine what areas of the Site visitors find most valuable, and customizing the Site based on your preferences on an ongoing basis.

Your browser or device may offer settings related to cookies, and you may be able to configure your browser not to accept cookies or to notify you when a cookie is being sent.  If you decide not to accept cookies from us, you may not be able to take advantage of all the Site’s features.

Local Shared Objects (sometimes referred to as “Flash Cookies”) are similar to standard cookies except that they can be larger and are downloaded to a computer or mobile device by the Adobe Flash media player.  Please note that you may need to take additional steps beyond changing your browser settings to refuse or disable Local Shared Objects and similar technologies.  For example, Local Shared Objects can be controlled through the instructions on Adobe’s Setting Manager page.  If you choose to refuse, disable, or delete these technologies, some of the functionality of the Site may no longer be available to you.

Internet Tags

“Internet tags” (also known as web beacons, single-pixel GIFs, clear GIFs, invisible GIFs, and 1-by-1 GIFs) are small pieces of code placed on web pages and in emails that tell a web site server information about your browser and device, such as the IP address and browser type related to the visitor’s computer.  Tags may be placed both on online advertisements that bring people to the site and on different pages of the site.  Such tags indicate how many times a page is opened and which information is consulted.

“Navigational data” (log files, server logs, and clickstream data) are used for system management, to improve the content of the site, for market research purposes, and to communicate information to visitors.

  1. Children’s Privacy

We do not knowingly collect any personal information from children under the age of 13 without parental consent, unless permitted by law.  If we learn that a child under the age of 13 has provided us with personal information, we will delete it in accordance with applicable law.

  1. Privacy Policy Changes

This Privacy Policy may be revised from time to time.  We will notify you by posting the revised Privacy Policy on the Site.  We recommend that you review this Privacy Policy frequently.

Your continued provision of personal information or use of our Site following any changes to this Privacy Policy constitutes your consent to any such changes.

  1. Contacting Us

You may contact us as described below with any questions, comments, or concerns about our Privacy Policy or personal information handling practices or to request additional information.

Valneva USA Inc.

Attention: Local Compliance Officer

910 Clopper Road Suite 160S

Gaithersburg, MD  20878

 

Or faxing us at 301-556-4501, attention Local Compliance Officer, Valneva USA Inc.

NOTE: If you are a physician or other health care professional and have questions or comments regarding our products, please contact our Medical Information Group at +1 844 349 42761 (8443-IXIARO) or via email at medinfo@valneva.com.

Indication & Usage

IXIARO is a vaccine indicated for the prevention of disease caused by Japanese encephalitis virus, approved for use in individuals 2 months of age and older.

Important Safety Information

Severe allergic reaction after a previous dose of IXIARO, any other Japanese encephalitis vaccine,  or any component of IXIARO,  including protamine sulfate a compound known to cause hypersensitivity reactions in some individuals is a contraindication to administration of IXIARO.  Individuals with a history of severe allergic reaction to another Japanese encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO is considered.

Vaccination with IXIARO may not protect all individuals.  Individuals with a weakened immune system may have a diminished immune response to IXIARO.  Fainting may occur when receiving any injection, including IXIARO.  Tell your healthcare practitioner if you have a history of fainting from injections.

The most common (>10%) adverse reactions were: fever, irritability, diarrhea, and injection site redness in infants 2 months to <1 year of age; fever in children 1 to <12 years of age; pain and tenderness in adolescents 12 to <18 years of age; and, headache, muscle pain, and injection site pain and tenderness in adults.

You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967.  You should ask your healthcare practitioner for medical advice about adverse events.

For more information, please see the physician’s Prescribing Information and ask your healthcare practitioner about the risk and benefits of IXIARO.

 

 

 

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1807-US-IX-044-1018 | 10/18 | Copyright © 2018 Valneva USA, Inc. All Rights Reserved.