Immunogenicity for MENVEO 1-vial presentation

Vaccination may not protect all recipients.
Not actual patients.

MENVEO is approved in 2 presentations1

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1-vial presentation

for use in individuals aged 10 through 55 years1

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2-vial presentation

for use in individuals aged 2 months through 55 years1

Immunogenicity of MENVEO 1-vial presentation vs MENVEO 2-vial presentation1,2

  • Primary objective2: To demonstrate noninferiority of MENVEO 1-vial presentation compared to MENVEO 2-vial presentation, as measured by the hSBA GMTs directed against N. meningitidis serogroup A at 1 month
  • Primary endpoint2: Noninferiority of immune response against MenA as a measure of the between-group ratio of hSBA GMTs at 1 month postvaccination

GMT Ratios at 28 Days Postvaccination in Patients Aged 10-40 Years2

MENVEO 1-vial presentation: GMT Ratios at 28 Days Postvaccination in Patients Aged 10-40 Years

*Primary endpoint noninferiority criterion: lower limit of the 2-sided 95% CI for the between-group hSBA GMT ratio against serogroup A >0.5 at 1 month postvaccination.1,2

†Noninferiority of responses for serogroups C, W, and Y was not tested, although the lower limits of the 2-sided 95% CI were above the noninferiority threshold in each case.1

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Study Design

The immunogenicity of MENVEO 1-vial presentation was evaluated in an observer-blind, randomized, multicenter, controlled clinical trial in individuals aged 10 to 40 years. The study compared the immune response of MENVEO 1-vial presentation to MENVEO 2-vial presentation.1,2

SEE SAFETY PROFILE
  • CI=confidence interval; GMT=geometric mean titer; hSBA=human serum bactericidal assay; MenA=meningococcal serogroup A; MenC=meningococcal serogroup C; MenW=meningococcal serogroup W; MenY=meningococcal serogroup Y.

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. 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