Safety Profile and Tolerability

TRUMENBA has a safety profile established in 11 clinical trials and more than 15,000 individuals worldwide.1

The safety data demonstrated that TRUMENBA was generally well tolerated1

The most common solicited adverse reactions in adolescents and young adults were1

  • Pain at the injection site (≥85%)
  • Fatigue (≥60%)
  • Muscle pain (≥35%)
  • Headache (≥55%)
Nausea was reported in up to 24% of adolescents in early phase studies.1
  • In clinical trials, the frequencies of adverse events occurred at lower rates with second and third doses of TRUMENBA compared with the first dose1
TRUMENBA is the only MenB vaccine with prefilled syringes not made with natural rubber latex.1
  • The tip cap and rubber plunger are not made with natural rubber latex

Use in Specific Populations1

  • Pregnancy: There are no adequate and well-controlled studies of TRUMENBA in pregnant women
  • Lactation: Available data are not sufficient to assess the effects of TRUMENBA on the breastfed infant or on milk production/excretion
  • Pediatric use: Safety and effectiveness have not been established in children <10 years of age. In a clinical study, 90% of infants <12 months of age who were vaccinated with a reduced dosage formulation had fever
  • Geriatric use: Safety and effectiveness in adults >65 years of age have not been established
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