Demonstrated safety profile

Vaccination may not protect all recipients.
Not actual patients.

Demonstrated safety profile in adolescents1

Solicited Adverse Reactions Within 7 Days Following Primary Vaccination in Individuals Aged 11 Through 18 Years1

MENVEO 1-Vial Presentation: Solicited Adverse Reactions Within 7 Days Following Primary Vaccination in Individuals Aged 11 Through 18 Years

*Severe: Unable to perform normal daily activity.

Solicited Adverse Reactions in the Booster Vaccination Study (Adolescents and Adults)1

A multicenter, open-label clinical trial was conducted in the US in 601 subjects aged 15 through 51 years who 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). The methodology for evaluating solicited adverse reactions, unsolicited adverse events, and serious adverse events after a booster dose of MENVEO was similar to the primary vaccination studies.1

Similar rates of solicited adverse reactions were observed following a single booster dose. The most common solicited local and systemic adverse reactions within 7 days of vaccination were pain at injection site (36%) and fatigue (38%), respectively.1

MENVEO 1-Vial Presentation: Solicited Adverse Reactions Within 7 Days Following Primary Vaccination in Individuals Aged 10 to 44 Years2,3

MENVEO 1-Vial Presentation: Solicited Adverse Reactions Within 7 Days Following Primary Vaccination in Individuals Aged 10 to 44 Years

The safety of MENVEO 1-vial presentation was evaluated in 2 randomized clinical trials. In these studies, 1,337 subjects aged 10 through 44 years were administered a single dose of MENVEO 1-vial presentation and contributed to study analyses and 1,332 subjects 10 through 40 years of age were administered MENVEO 2-vial presentation. One study was conducted in Australia, Belgium, Canada, Germany, and Italy, and the other study was conducted in Brazil, Estonia, Finland, France, Mexico, Russian Federation, South Africa, Spain, and Turkey. Overall, in these studies, subjects were White (80.8%), followed by Hispanic or Latino ethnicity (12.8%), other racial groups (11.4%), African American (4.3%), Asian (3.0%), American Indian or Alaskan Native (0.3%), and Native Hawaiian or other Pacific Islander (0.1%). Overall, 25.6% of individuals were aged 10 through 17 years, and 74.4% were aged 18 through 44 years. There were no notable differences in frequency and severity of solicited adverse reactions within 7 days following vaccination in individuals who received the 1-vial presentation compared to individuals who received the 2-vial presentation.1

MENVEO 2-vial presentation: Demonstrated safety profile in infants and toddlers1

Solicited Adverse Reactions in Infant and Toddler Patients 2 to 23 Months of Age Who Received MENVEO 2-Vial Presentation at 2, 4, 6, and 12 Months of Age Within 7 Days After Any Dose1

Chart: Solicited Adverse Reactions in Infant and Toddler Patients 2 to 23 Months of Age Who Received MENVEO 2-Vial Presentation at 2, 4, 6, and 12 Months of Age Within 7 Days After Any Dose

*MENVEO 2-vial presentation plus routine vaccinations, including diphtheria toxoid, tetanus toxoid, and acellular pertussis, inactivated poliovirus types 1, 2, and 3, hepatitis B, Haemophilus influenzae type b, and 7-valent pneumococcal conjugate (PCV7) at Doses 1, 2, 3; and PCV7, measles, mumps, rubella, varicella, and hepatitis A vaccines at Dose 4. Hepatitis B vaccine and rotavirus vaccines were allowed according to CDC recommendations.

†Routine vaccinations alone.

VIEW STUDY DESIGN
  • CDC=Centers for Disease Control and Prevention.

Indication & Important Safety Info

Indication

Important Safety 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 with MENVEO 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

 

Please see full Prescribing Information for MENVEO.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or
1-888-825-5249, or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

References

  1. Prescribing Information for MENVEO.

  2. Vandermeulen C, Leroux-Roels I, Vandeleur J, et al. A new fully liquid presentation of MenACWY-CRM conjugate vaccine: results from a multicentre, randomised, controlled, observer-blind study. Vaccine. 2021;39(45):6628-6636. doi:10.1016/j.vaccine.2021.09.068

  3. Díez-Domingo J, Tinoco JC, Poder A, et al. Immunological non-inferiority of a new fully liquid presentation of the MenACWY-CRM vaccine to the licensed vaccine: results from a randomized, controlled, observer-blind study in adolescents and young adults. Hum Vaccin Immunother. 2022;18(1):1981085. doi:10.1080/21645515.2021.1981085