Safety profile of the adjuvanted recombinant zoster vaccine : Pooled analysis of two large randomised phase 3 trials

• Background: The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies. Methods: Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12 months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period. Results: Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race. Conclusions: No safety concerns arose, supporting the favorable benefit-risk profile of RZV. © 2019 GlaxoSmithKline Biologicals SA

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Hälsovetenskap -- Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Health Sciences -- Public Health, Global Health, Social Medicine and Epidemiology (hsv//eng)

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Allmänmedicin (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- General Practice (hsv//eng)

Nyckelord

Reactogenicity

Safety

Vaccine

Varicella-zoster virus

placebo

varicella zoster vaccine

acute kidney failure

adult

age distribution

aged

alopecia areata

aortic stenosis

arthralgia

Article

atrial fibrillation

autoimmune pancreatitis

autoimmune thyroiditis

backache

brain infarction

cardiogenic shock

cardiopulmonary insufficiency

celiac disease

cerebrovascular accident

chill

chronic gastritis

chronic obstructive lung disease

clinical evaluation

cohort analysis

controlled study

coughing

Crohn disease

disease course

dizziness

drug efficacy

drug safety

erythema nodosum

facial nerve paralysis

fatigue

female

fever

fibrosing alveolitis

follow up

glomerulonephritis

Graves disease

Guillain Barre syndrome

headache

heart atrium flutter

heart failure

heart infarction

herpes zoster

human

idiopathic thrombocytopenic purpura

immunoglobulin A nephropathy

information processing

injection site erythema

injection site pain

injection site pruritus

injection site swelling

injection site warmth

insulin dependent diabetes mellitus

lichen planus

lung fibrosis

lung tumor

major clinical study

malaise

male

mixed connective tissue disease

multiple organ failure

multiple sclerosis

myalgia

neuritis

oropharynx pain

pancreas carcinoma

paraneoplastic neuropathy

pemphigus

phase 3 clinical trial

pneumonia

polyradiculoneuropathy

population research

priority journal

psoriasis

psoriatic arthritis

race

radiculitis

randomized controlled trial

Raynaud phenomenon

respiratory failure

retina detachment

rheumatic polymyalgia

rheumatoid arthritis

rhinopharyngitis

sepsis

septic shock

sex ratio

single blind procedure

spondyloarthropathy

supraventricular tachycardia

syndrome CREST

systemic juvenile idiopathic arthritis

systemic lupus erythematosus

tachycardia

temporal arteritis

trigeminal nerve disease

trigeminus neuralgia

ulcerative colitis

upper respiratory tract infection

uveitis

vaccination

vitiligo

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