See the immunogenicity in adolescents
See the seroresponse rates for MENVEO in adolescent patients
The immunogenicity of MENVEO was evaluated 28 days after vaccination in a pivotal noninferiority trial that compared MENVEO with Menactra. The primary endpoint was the percentage of subjects with a seroresponse 28 days after a dose of either MENVEO or Menactra.1
Seroresponse was defined as1:
- A postvaccination hSBA ≥1:8 for subjects with a prevaccination hSBA <1:4 or
- At least a 4-fold increase above baseline titers for subjects with a prevaccination hSBA ≥1:4
For all 4 serogroups (A, C, W-135, and Y), noninferiority criteria for MENVEO compared to Menactra were met.1
MENVEO does not prevent N. meningitidis serogroup B infections.1
Seroresponse Rates at 28 days Postvaccination in Adolescents 11-18 Years of Age1
See the Relative Geometric Mean Titer (GMT) Rates vs Menactra1
CI=confidence interval; hSBA=human serum bactericidal assay.
This head-to-head study also measured GMTs in subjects 1 month after a dose of either MENVEO or Menactra in 11- to 18-year-olds. GMTs are a measure of the level of immune response to a vaccine in a specific study group.1
The point estimates for fold differences in GMTs between MENVEO and Menactra are >1 for all 4 serogroups, although for serogroup C the confidence interval includes 1. The clinical significance of these differences is unknown.1
- *GMTs are a measure of the level of immune response to a vaccine in a specific study group. GMTs for MENVEO were evaluated at 28 days postvaccination.1
Randomized, multicenter, active-controlled study in healthy adolescents 11-18 years of age. Subjects were randomized to receive 1 dose of MENVEO or Menactra. Noninferiority criterion for the primary endpoint was met for all serogroups (lower limit of the 2-sided 95% CI > -10% for vaccine group differences [MENVEO minus Menactra]). In separate studies, for the proportion of subjects with a seroresponse, noninferiority criterion was met for serogroups C, W-135, and Y but not for serogroup A in subjects 2-5 years and 6-10 years of age, and was met for all serogroups in subjects 19-55 years of age.1 The clinical significance of these differences is unknown.
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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