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See the immunogenicity for booster dosing

95% to 97% of subjects who received a prior dose of MENVEO achieved seroresponse for serogroups A, C, W-135, and Y1,2

  • In a multicenter, open-label trial conducted in the US, 601 subjects aged 15-51 years* received a single booster dose of MENVEO 4 to 6 years after prior vaccination with MENVEO (n=301; median age: 16 years) or Menactra (n=300; median age: 16 years)1,2
  • The co-primary immunogenicity endpoints were hSBA seroresponse to each serogroup 29 days (a) following a booster vaccination with MENVEO given to subjects who received a prior dose of MENVEO, and (b) following a booster vaccination with MENVEO given to subjects who received a prior dose of Menactra1,2
  • Similar seroresponse rates were observed for subjects who received a booster vaccination with MENVEO following a prior dose of either MENVEO or Menactra1,2

Seroresponse at Day 29 After a Booster Dose of MENVEO1

CI=confidence interval; MenACWY=meningococcal serogroups A, C, W, Y; hSBA=human serum bactericidal assay.

  •   *Participants aged 15-51 were primed with MENVEO or Menactra 4-6 years prior to the booster dose of MENVEO. The 15- to 55-year-old age group (ie, the naïve group) included individuals who received their 1st and only MenACWY dose as MENVEO.1,2
  •   †Seroresponse was defined as (a) post-vaccination hSBA ≥1:16 for subjects with a baseline hSBA <1:4 or (b) at least 4-fold higher than baseline titers for subjects with a pre-vaccination hSBA ≥1:4.2

A single booster dose of MENVEO may be administered to individuals aged 15 through 55 years who are at continued risk for meningococcal disease if at least 4 years have elapsed since a prior dose of a MenACWY vaccine.2

References

  1. Tipton M, Daly W, Senders S, et al. MenACWY-CRM conjugate vaccine booster dose given 4-6 years after priming: results from a phase IIIb, multicenter, open label study in adolescents and adults. Vaccine. 2019;37(42):6171-6179.
  2. Prescribing Information for MENVEO.

INDICATION

MENVEO is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in individuals 2 months through 55 years of age. MENVEO does not prevent N. meningitidis serogroup B infections.

IMPORTANT SAFETY INFORMATION FOR MENVEO

  • Do not administer MENVEO to individuals with a severe allergic reaction (eg, anaphylaxis) to a previous dose of MENVEO, to any component of this vaccine, or to any other diphtheria toxoid-containing vaccine
  • Appropriate medical treatment must be available should an acute allergic reaction, including an anaphylactic reaction, occur following administration of MENVEO
  • Syncope (fainting) has occurred in association with administration of MENVEO. Procedures should be in place to avoid injury from fainting
  • Some individuals with altered immunocompetence, including some individuals receiving immunosuppressant therapy, may have reduced immune responses to MENVEO
  • Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis serogroups A, C, Y, and W, even if they develop antibodies following vaccination with MENVEO
  • Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of another US-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision to administer MENVEO to individuals with a history of GBS should take into account the expected benefits and potential risks
  • Apnea following intramuscular vaccination has been observed in some infants born prematurely. A decision about when to administer MENVEO to an infant born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination
  • Common solicited adverse reactions among children initiating vaccination: at 2 months of age and receiving the four-dose series were tenderness and erythema at injection site, irritability, sleepiness, persistent crying, change in eating habits, vomiting, and diarrhea; at 7 months through 23 months of age and receiving the two-dose series were tenderness and erythema at injection site, irritability, sleepiness, persistent crying, change in eating habits, and diarrhea; at 2 through 10 years of age who received MENVEO were injection site pain, erythema, irritability, induration, sleepiness, malaise, and headache. Common solicited adverse reactions among adolescents and adults aged 11 through 55 years who received a single dose of MENVEO were pain at the injection site, headache, myalgia, malaise, and nausea. Across all age groups, some events were severe. Similar rates of solicited adverse reactions among adolescents and adults were observed following a single booster dose
  • In two clinical studies, there were no notable differences in frequency and severity of solicited adverse reactions in individuals who received MENVEO 1-vial presentation compared to individuals who received the 2-vial presentation
  • Vaccination with MENVEO may not result in protection in all vaccine recipients

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