Indications for: MENVEO
Primary Vaccination Studies
Immunogenicity in Infants/Toddlers Aged 2 Months through 12 Months
A randomized, controlled, multicenter study (NCT01000311) evaluated the efficacy of Menveo in infants (mean age at enrollment was 65 days). The predefined criteria for immunogenicity were met for all 4 serogroups A, C, W-135, and Y at 1 month following completion of a 4-dose series at 2, 4, 6, and 12 months of age. The percentage of subjects with hSBA ≥1:8 at 7 months was 94% to 98% for serogroups C, W-135, and Y and 76% for serogroup A.
A randomized, controlled, multicenter clinical trial (NCT00626327) evaluated the efficacy of 2 doses of Menveo administered at 7–9 months and 12 months of age in 386 participants (mean age at enrollment was 8.5 months). The study also evaluated Menveo concomitantly administered with MMRV. Among the per-protocol population, after Menveo administered at 7-9 and at 12 months, the proportions of subjects with hSBA ≥1:8 for serogroups A, C, W-135, and Y were respectively: 88% (84-91), 100% (98-100), 98% (96-100), 96% (93-99).
Immunogenicity in Children Aged 2 Years through 10 Years
A randomized, multicenter, active-controlled clinical study (NCT00616421) compared hSBA response after 1 dose of Menveo or Menactra in participants aged 2 to 10 years of age. Participants were randomly assigned to receive a single dose of Menveo (n=1170) or Menactra (n=1161), and included serological results for 89% to 95% of participants.
In a separate group of children aged 2 to 5 years who received 2 doses of Menveo administered 2 months apart, the serologic results included 96% to 99% of participants.
Menveo achieved noninferiority to Menactra in participants aged 2 to 5 years and 6 to 10 years for seroresponse rates for serogroups C, W-135, and Y, but not for serogroup A.
In 297 per-protocol participants aged 2 to 5 years who were observed 1 month after the second dose of Menveo, the proportions of participants with seroresponse (95% CI) were: 91% (87-94), 98% (95-99), 89% (85-92), and 95% (91-97) for serogroups A, C, W-135, and Y, respectively. The proportion of participants with hSBA ≥1:8 (95% CI) were 91% (88-94), 99% (97-100), 99% (98-100), and 98% (95-99) for serogroups A, C, W-135, and Y, respectively. The hSBA GMTs (95% CI) for this group were 64 (51-81), 144 (118-177), 132 (111-157), and 102 (82-126) for serogroups A, C, W-135, and Y, respectively.
Immunogenicity in Adolescents Aged 11 Years through 18 Years
A randomized, multicenter, active-controlled clinical study (NCT00450437) compared the hSBA responses after 1 dose of Menveo or Menactra in 3539 participants aged 11 to 55 years. Participants were randomly assigned to receive Menveo (n=2663) or Menactra (n=876).
In participants 11 to 18 years of age, Menvo achieved noninferiority to Menactra for all 4 serogroups.
Immunogenicity in Adults Aged 19 Years through 55 Years
The study described above for participants 11 through 18 years of age was stratified by age to include participants aged 11 through 55 years of age. Menveo achieved noninferiority to Menactra for all 4 serogroups.
Immunogenicity of Menveo One-Vial Presentation in Individuals Aged 10 Years through 40 Years
An observer-blind randomized, multicenter, controlled clinical trial (NCT03433482) compared the immune response of Menveo one-vial presentation to the two-vial presentation in individuals 10 to 40 years of age.
The one-vial presentation achieved noninferiority to the two-vial presentation for MenA serogroup hSBA GMTs at 28 days post-vaccination. In secondary analyses, comparable immune responses were observed against N. meningitidis serogroups C, W-135 and Y as measured by hSBA GMTs. Additional secondary analyses demonstrated comparable percentages of subjects with hSBA titers ≥8, and percentages of subjects with a ≥4-fold rise in titers compared to baseline for serogroups A, C, W-135 and Y.
Booster Vaccination Study
Immunogenicity in Adolescents and Adults Aged 15 Years through 55 Years
In a multicenter, open-label trial (NCT02986854) conducted in the US, 601 participants aged 15 to 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).
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 Menactra.
Seroresponse rates at Day 29 following a booster vaccination with Menveo were 97% for serogroup A, 95% for serogroup C, 96% for serogroup W-135, and 97% for serogroup Y, in subjects who had received a prior dose of Menveo. At Day 6, following a booster vaccination, seroresponse rates were 39%, 51%, 50%, and 49% for serogroups A, C, W-135, and Y, respectively, in subjects who had received a prior dose of Menveo.
The hSBA GMTs were 13, 92, 112, and 63 for serogroups A, C, W-135, and Y at Day 6, and 210, 1160, 1395, and 1067, respectively, for the 4 serogroups at Day 29 following a booster dose of Menveo.
Booster vaccinations with Menveo following a prior dose of Menactra achieved similar seroresponse rates and GMTs.
Adults and Children:
<2mos: not established. Use two-vial presentation in individuals 2mos–55yrs. Use one-vial presentation in individuals 10–55yrs. Give by IM inj only. Infants: give in anterolateral thigh; toddlers, adolescents and adults: in deltoid muscle. Primary vaccination (2mos): as a four-dose series at 2, 4, 6, and 12mos of age; (7–23mos): as a two-dose series with the 2nd dose given in the 2nd year of life and at least 3mos after the 1st dose; (2–55yrs): 0.5mL once. For children 2–5yrs: if continued high risk, may give a 2nd dose 2mos after the 1st dose. Booster vaccination (15–55yrs): may give a single dose (0.5mL) to individuals at continued risk, if at least 4yrs elapsed since a prior dose. All: observe for 15mins post-dose.
Life-threatening reaction to any previous CRM197 or other diphtheria toxoid or meningococcal-containing vaccine.
Immunodeficiency. Have epinephrine inj (1:1000) available. Known history of Guillain-Barre Syndrome. Complement deficiency, eculizumab recipients; increased risk of invasive meningococcal disease despite vaccination with Menveo. Pregnancy. Nursing mothers.
Immunosuppressants (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, high-dose steroids) may get suboptimal response. Concomitant vaccines: see full labeling.
Inj site pain, tenderness, erythema, induration; irritability, sleepiness, headache, malaise, nausea, myalgia, arthralgia; syncope (seizure-like movements possible post-dose), apnea in premature infants.
Carton (two-vial presentation)—5 doses (5 vials of lyophilized MenA conjugate component + 5 vials of liquid MenCYW-135 conjugate component); Carton (one-vial presentation)—10 doses