{"id":202,"date":"2024-10-10T04:43:19","date_gmt":"2024-10-10T04:43:19","guid":{"rendered":"https:\/\/ixchiq.ca\/hcp\/?page_id=202"},"modified":"2025-04-01T11:40:22","modified_gmt":"2025-04-01T11:40:22","slug":"safety-profile","status":"publish","type":"page","link":"https:\/\/ixchiq.ca\/hcp\/safety-profile\/","title":{"rendered":"Safety profile"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"202\" class=\"elementor elementor-202\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4690d365 e-flex e-con-boxed e-con e-child\" data-id=\"4690d365\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-b656290 e-con-full e-flex e-con e-child\" data-id=\"b656290\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1617d615 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"1617d615\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-160cb119 elementor-widget elementor-widget-heading\" data-id=\"160cb119\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">IXCHIQ\u2122 DEMONSTRATED A GENERALLY WELL-TOLERATED SAFETY PROFILE<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-20d61c3 e-con-full e-flex e-con e-child\" data-id=\"20d61c3\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8a0e2e5 elementor-widget elementor-widget-heading\" data-id=\"8a0e2e5\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">The safety and tolerability profile of IXCHIQ\u2122 was evaluated from 3 randomized, multicenter clinical studies.<sup>1<\/sup>* <\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bbe6bf0 elementor-widget elementor-widget-heading\" data-id=\"bbe6bf0\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">The IXCHIQ\u2122 safety data below was collected in 4115 participants from the main VLA1553-301 clinical trial, randomized 3:1 to receive IXCHIQ\u2122 or placebo where 3082 healthy adults (18\u201388 years of age) received a single dose of IXCHIQ\u2122 and 1033 received a placebo (Phosphate Buffered Saline). Participants were followed-up for safety for 6 months post-vaccination.<sup>1<\/sup><\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-936ad79 e-con-full e-flex e-con e-child\" data-id=\"936ad79\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3d7cc92 elementor-widget elementor-widget-heading\" data-id=\"3d7cc92\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">SOLICITED SYSTEMIC AND INJECTION SITE ADVERSE EVENTS WITHIN 10 DAYS AFTER A SINGLE VACCINATION (SAFETY POPULATION IN STUDY VLA1553-301)<sup>1<\/sup><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-88d4598 elementor-widget elementor-widget-image\" data-id=\"88d4598\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1868\" height=\"665\" src=\"https:\/\/ixchiq.ca\/hcp\/wp-content\/uploads\/2025\/04\/VAL25101_Infographic_Table_1-1.png\" class=\"attachment-full size-full wp-image-3534\" alt=\"well-tolerated-safety-profile\" srcset=\"https:\/\/ixchiq.ca\/hcp\/wp-content\/uploads\/2025\/04\/VAL25101_Infographic_Table_1-1.png 1868w, https:\/\/ixchiq.ca\/hcp\/wp-content\/uploads\/2025\/04\/VAL25101_Infographic_Table_1-1-300x107.png 300w, https:\/\/ixchiq.ca\/hcp\/wp-content\/uploads\/2025\/04\/VAL25101_Infographic_Table_1-1-1024x365.png 1024w, https:\/\/ixchiq.ca\/hcp\/wp-content\/uploads\/2025\/04\/VAL25101_Infographic_Table_1-1-768x273.png 768w, https:\/\/ixchiq.ca\/hcp\/wp-content\/uploads\/2025\/04\/VAL25101_Infographic_Table_1-1-1536x547.png 1536w\" sizes=\"(max-width: 1868px) 100vw, 1868px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cdc4636 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"cdc4636\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\tAdapted from the IXCHIQ\u2122 Product Monograph.<sup>1<\/sup>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f728832 elementor-widget elementor-widget-text-editor\" data-id=\"f728832\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\tAll solicited injection site adverse reactions were graded as mild or moderate in severity, except for a single solicited injection site adverse reaction of pain graded as severe in the IXCHIQ\u2122 group. \t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ee09217 elementor-widget elementor-widget-heading\" data-id=\"ee09217\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Local and systemic adverse reactions resolved with a median duration of 2 days.<sup>1<\/sup><\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-681b814 elementor-widget elementor-widget-heading\" data-id=\"681b814\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\"><div class=\"indent\"><span>* Studies (VLA1553-301, VLA1553-302, and VLA1553-101) all conducted in North America in healthy adult participants 18 years of age and older. Study VLA1553-101 was done using an earlier formulation and was a supportive dose-escalation Phase I trial of IXCHIQ\u2122 in 120 participants. Study VLA1553-301 was the pivotal double-blind placebo-controlled Phase III trial in 4115 participants who received IXCHIQ\u2122 or placebo (phosphate buffered saline) as a single dose. Study VLA1553-302 was a supportive non-placebo-controlled Phase III trial investigating the consistency of three lots of IXCHIQ\u2122 given as a single dose in 408 participants.<\/span><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-04f7555 e-con-full e-flex e-con e-parent\" data-id=\"04f7555\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-195291f elementor-widget elementor-widget-image\" data-id=\"195291f\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"301\" height=\"301\" src=\"https:\/\/ixchiq.ca\/hcp\/wp-content\/uploads\/2024\/10\/Ixchic_Icon_people.jpg\" class=\"attachment-full size-full wp-image-1300\" alt=\"\" srcset=\"https:\/\/ixchiq.ca\/hcp\/wp-content\/uploads\/2024\/10\/Ixchic_Icon_people.jpg 301w, https:\/\/ixchiq.ca\/hcp\/wp-content\/uploads\/2024\/10\/Ixchic_Icon_people-150x150.jpg 150w\" sizes=\"(max-width: 301px) 100vw, 301px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5c2d3e2 e-flex e-con-boxed e-con e-parent\" data-id=\"5c2d3e2\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7fcf786 elementor-widget elementor-widget-heading\" data-id=\"7fcf786\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">FREQUENCY OF CHIKUNGUNYA-LIKE ADVERSE REACTIONS<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5871f25 e-con-full e-flex e-con e-child\" data-id=\"5871f25\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-220deaf e-con-full e-flex e-con e-child\" data-id=\"220deaf\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c9318d6 elementor-widget elementor-widget-text-editor\" data-id=\"c9318d6\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul class=\"para\"><li>In Study VLA1553-301, participants were monitored for a cluster of symptoms consistent with wild-type chikungunya infection.<sup>1<\/sup><\/li><li>Chikungunya-like adverse reactions were defined as:<sup>1<\/sup><br \/><ul class=\"dashed-list\"><li>Fever (\u226538 \u00b0C )<\/li><li>One or more of any of the following: arthralgia or arthritis, myalgia, headache, back pain, rash, lymphadenopathy, or certain neurological, cardiac or ocular symptoms that occurred with an onset within 30 days after vaccination, regardless of whether they occurred simultaneously or not.<\/li><\/ul><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-359e34c e-con-full e-flex e-con e-child\" data-id=\"359e34c\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-849ce69 elementor-widget elementor-widget-text-editor\" data-id=\"849ce69\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul class=\"para\">\n \t<li>Severe chikungunya-like adverse reactions included symptoms that prevented daily activity and\/or required medical intervention.<sup>1<\/sup><\/li>\n \t<li>Among Study VLA1553-301 participants, 11.7% in the IXCHIQ\u2122 group (n= 3082) reported chikungunya-like adverse reactions, including 1.6% who reported severe chikungunya-like adverse reactions. 0.6% participants in the placebo group (n=1033) reported chikungunya-like adverse reactions, none of which were severe.<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ac2a25e e-flex e-con-boxed e-con e-parent\" data-id=\"ac2a25e\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-cf1c844 e-con-full e-flex e-con e-child\" data-id=\"cf1c844\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-52303c6 elementor-widget elementor-widget-heading\" data-id=\"52303c6\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">FREQUENCY OF SYMPTOMS AMONG PARTICIPANTS WITH CHIKUNGUNYA-LIKE ADVERSE REACTIONS (STUDY VLA1553-301)<sup>1<\/sup><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9cf7ce4 elementor-hidden-mobile elementor-widget elementor-widget-image\" data-id=\"9cf7ce4\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1742\" height=\"723\" src=\"https:\/\/ixchiq.ca\/hcp\/wp-content\/uploads\/2024\/10\/IXCHIQ_HCP.jpg\" class=\"attachment-full size-full wp-image-872\" alt=\"\" srcset=\"https:\/\/ixchiq.ca\/hcp\/wp-content\/uploads\/2024\/10\/IXCHIQ_HCP.jpg 1742w, https:\/\/ixchiq.ca\/hcp\/wp-content\/uploads\/2024\/10\/IXCHIQ_HCP-300x125.jpg 300w, https:\/\/ixchiq.ca\/hcp\/wp-content\/uploads\/2024\/10\/IXCHIQ_HCP-1024x425.jpg 1024w, https:\/\/ixchiq.ca\/hcp\/wp-content\/uploads\/2024\/10\/IXCHIQ_HCP-768x319.jpg 768w, https:\/\/ixchiq.ca\/hcp\/wp-content\/uploads\/2024\/10\/IXCHIQ_HCP-1536x638.jpg 1536w\" sizes=\"(max-width: 1742px) 100vw, 1742px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cb886f9 elementor-hidden-desktop elementor-hidden-laptop elementor-hidden-tablet elementor-widget elementor-widget-image\" data-id=\"cb886f9\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"366\" height=\"583\" src=\"https:\/\/ixchiq.ca\/hcp\/wp-content\/uploads\/2024\/10\/safety-profile-table-2.png\" class=\"attachment-full size-full wp-image-1689\" alt=\"\" srcset=\"https:\/\/ixchiq.ca\/hcp\/wp-content\/uploads\/2024\/10\/safety-profile-table-2.png 366w, https:\/\/ixchiq.ca\/hcp\/wp-content\/uploads\/2024\/10\/safety-profile-table-2-188x300.png 188w\" sizes=\"(max-width: 366px) 100vw, 366px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-19763b2 elementor-widget elementor-widget-text-editor\" data-id=\"19763b2\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\tAdapted from the IXCHIQ\u2122 Product Monograph.<sup>1<\/sup>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-0fc88ee e-con-full e-flex e-con e-child\" data-id=\"0fc88ee\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-0739a4d e-con-full e-flex e-con e-child\" data-id=\"0739a4d\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-819aaaa elementor-widget elementor-widget-text-editor\" data-id=\"819aaaa\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul>\n \t<li>The median onset of chikungunya-like adverse reactions in IXCHIQ\u2122 recipients was 3.0 days (range 0 to 10 days) after vaccination. The median duration of chikungunya-like adverse reactions in IXCHIQ\u2122 recipients was 4.0 days (range 1 day to at least 6 months) after vaccination.<sup>1<\/sup><\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2795d04 e-con-full e-flex e-con e-child\" data-id=\"2795d04\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1124a1c elementor-widget elementor-widget-text-editor\" data-id=\"1124a1c\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>22 IXCHIQ\u2122 recipients had prolonged chikungunya-like adverse reactions lasting longer than 14 days (median duration 33 days, range 15 days to at least 6 months) and 15 IXCHIQ\u2122 recipients had chikungunya-like adverse reactions lasting longer than 28 days (median duration 94 days, range 29 days to at least 6 months).<sup>1<\/sup><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-47a32f5 e-flex e-con-boxed e-con e-parent\" data-id=\"47a32f5\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a3b3b46 elementor-widget elementor-widget-heading\" data-id=\"a3b3b46\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">SERIOUS ADVERSE EVENTS<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-52153f6 elementor-widget elementor-widget-text-editor\" data-id=\"52153f6\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>The proportions of participants who reported at least one serious adverse event within 6 months following administration was 1.5% (46\/3082) in the IXCHIQ\u2122 group and 0.8% (8\/1033) in the placebo group. Overall, there were two serious adverse events (2\/3082 [0.1%]) requiring hospitalization that were considered to be related to IXCHIQ\u2122: 1 event of myalgia, and 1 event of hypovolemic hyponatremia and atrial fibrillation, both events showed full recovery. There were no serious adverse events reported in the placebo group.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f635b99 elementor-widget elementor-widget-heading\" data-id=\"f635b99\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">DEATHS AND ADVERSE EVENTS LEADING TO WITHDRAWAL FROM STUDY<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a95348d elementor-widget elementor-widget-text-editor\" data-id=\"a95348d\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>Three participants died during Study VLA1553-301 due to events independent of study procedures (coronary artery disease, COVID-19, and anoxic brain injury). <strong>None of the deaths was considered as related to IXCHIQ\u2122<\/strong>. Approximately 0.1% of participants who received IXCHIQ\u2122 vs. 0.2% in the placebo group discontinued their trial participation due to adverse events.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fa971c4 elementor-widget elementor-widget-heading\" data-id=\"fa971c4\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">For more information on clinical trial adverse reactions, please refer to the IXCHIQ\u2122 Product Monograph.<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-58fc805 elementor-widget elementor-widget-heading\" data-id=\"58fc805\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\"><div class=\"indent\"><span>* Studies (VLA1553-301, VLA1553-302, and VLA1553-101) all conducted in North America in healthy adult participants 18 years of age and older. Study VLA1553-101 was done using an earlier formulation and was a supportive dose-escalation Phase I trial of IXCHIQ\u2122 in 120 participants. Study VLA1553-301 was the pivotal double-blind placebo-controlled Phase III trial in 4115 participants who received IXCHIQ\u2122 or placebo (phosphate buffered saline) as a single dose. Study VLA1553-302 was a supportive non-placebo-controlled Phase III trial investigating the consistency of three lots of IXCHIQ\u2122 given as a single dose in 408 participants.<\/span><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-10e40ee e-flex e-con-boxed e-con e-parent\" data-id=\"10e40ee\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3fdf311 elementor-align-right elementor-widget__width-inherit elementor-widget elementor-widget-button\" data-id=\"3fdf311\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/ixchiq.ca\/hcp\/dosing-reconstitution\/\" id=\"btn_2\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-chevron-right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">DOSING &amp; RECONSTITUTION<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>IXCHIQ\u2122 DEMONSTRATED A GENERALLY WELL-TOLERATED SAFETY PROFILE The safety and tolerability profile of IXCHIQ\u2122 was evaluated from 3 randomized, multicenter clinical studies.1* The IXCHIQ\u2122 safety data below was collected in 4115 participants from the main VLA1553-301 clinical trial, randomized 3:1 to receive IXCHIQ\u2122 or placebo where 3082 healthy adults (18\u201388 years of age) received a [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-202","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - 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