SHINGRIX

Scientific Rationale Video

The Scientific Rationale Video provides an engaging and easily understood look into the science behind the development of SHINGRIX.

Contraindications:

Patients with a known hypersensitivity to the active substance or to any component of the vaccine.

Most serious warnings and precautions:

Administration: Do not administer the vaccine intravascularly, intradermally or subcutaneously.

Other relevant warnings and precautions:

• A protective immune response may not be elicited in all vaccinees
• Not for prevention of primary varicella infection or treatment of HZ or postherpetic neuralgia
• Postpone in those with acute severe febrile illness
• Use with caution in those with thrombocytopenia or any coagulation disorder
• Syncope following or before any vaccination as a psychogenic response
• Use in special populations such as pregnant or nursing women or pediatrics (<18 years of age) has not been established
• Limited data in immunocompromised adults 50 years of age or older

Adverse events:

• Solicited local and general adverse reactions that occurred in clinical trials within 7 days of vaccination in subjects aged 50–69 and ≥70 years respectively were: pain (85.6%, 69.2%), redness (38.5%, 37.7%), swelling at the injection site (28.5%, 23.0%), myalgia (53.0%, 35.1%), fatigue (51.3%, 36.6%), headache (45.2%, 29.0%), shivering (33.1%, 19.5%), fever (25.9%, 14.3%), gastrointestinal symptoms (20.5%, 13.5%)
• Unsolicited adverse reactions that occurred in clinical trials within 30 days of vaccination in ≥1% of subjects and ≥2-fold higher than placebo recipients included chills (3.5%), injection site pruritus (2.2%), and malaise (1.7%)
• Post-market adverse reactions are hypersensitivity reactions (rare), including rash, urticaria, angioedema

For more information

Please consult the product monograph at gsk.ca/SHINGRIX/PM for important information relating to dosing and administration, adverse reactions, contraindications and drug interactions which have not been discussed in this piece. To request a product monograph, or to report an adverse event please call 1-800-387-7374.

* Clinical significance has not been established.
† Modified Total Vaccinated Cohort (mTVC) was the primary efficacy analysis and included all subjects randomized in the study who received a second dose of the vaccine and did not develop a confirmed case of shingles within one month after the second dose.
‡ Reproduction of information from the PIQ, 7th ed. Zona-SU section; http://www.msss.gouv.qc.ca/professionnels/vaccination/piq-vaccins/zona-su-vaccin-sous-unitaire-contre-le-zona/
The original French version of this information was published in 2018 by the Department of Health and Social Services. The Dept. declines any responsibility for any damage, loss or injury that may result from this translation into English. In case of contradiction between the English and French versions of this information, the latter it will prevail. The Government of Quebec is and remains the only copyright owner of the work in French. The English version has not been validated by the Ministry of Health and Social Services.