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Table 5 Severity grading for unsolicited adverse eventsa

From: Study protocol for a phase 1/2, single-centre, double-blind, double-dummy, randomized, active-controlled, age de-escalation trial to assess the safety, tolerability and immunogenicity of a measles and rubella vaccine delivered by a microneedle patch in healthy adults (18 to 40 years), measles and rubella vaccine-primed toddlers (15 to 18 months) and measles and rubella vaccine-naïve infants (9 to 10 months) in The Gambia [Measles and Rubella Vaccine Microneedle Patch Phase 1/2 Age De-escalation Trial]

  

Description

Grade 1

Mild

No interference with activity and no or minimal intervention1 required

Grade 2

Moderate

Some interference with activity or requires more than minimal intervention

Grade 3

Severe

Prevents daily activity and required significant medical intervention

Grade 4

Life-threatening

Life-threatening consequences requiring urgent medical intervention

Grade 5

Death

Results in death

  1. aAdapted from Cancer Therapy Evaluation Program, Common Terminology Criteria for AEs, version 3.0, DCTD, NCI, NIH, DHHS March 31, 2003, published on August 9, 2006
  2. 1One or two doses of antipyretic or simple analgesic medication or local topical treatment
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Trials

ISSN: 1745-6215