DEMONSTRATED SAFETY PROFILE

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Demonstrated safety profile in adolescents

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
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.

  • Study Design

    In a multicenter phase 3 study, 2180 adolescents 11-18 years of age were randomly assigned to 4 groups (1:1:1:1) to receive a single dose of 1 of 3 lots of MENVEO or a single dose of Menactra. Subjects were monitored for immediate reactions for 30 minutes after vaccination. Solicited local and systemic adverse events and oral temperature were recorded on diary cards for 7 days after vaccination. Other adverse events were recorded on the diary cards with reminder phone calls performed on postvaccination day 3. Serious adverse events and medically significant adverse events that required a physician’s visit or led to subject withdrawal from the study were recorded during 6 months of follow-up.1

    Reference: 1. Jackson LA, Baxter R, Reisinger K, et al; The V59P13 Study Group. Phase III comparison of an investigational quadrivalent meningococcal conjugate vaccine with the licensed meningococcal ACWY conjugate vaccine in adolescents. Clin Infect Dis. 2009;49(1):e1-10. doi:10.1086/599117

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

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
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

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

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
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
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
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
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
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
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
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

VIEW STUDY DESIGN

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 ACIP recommendations.

Routine vaccinations alone.

Vaccination may not protect all recipients.

ACIP=Advisory Committee on Immunization Practices.