Menveo Vaccine Clinical Trials, Dosage, Efficacy 

GSK's Menveo helps protect eligible adolescent patients with a primary and booster dose. It consists of two portions: 10 µg of lyophilized meningococcal serogroup A capsular polysaccharide conjugated to CRM197 and 5 μg each of capsular polysaccharide of serogroups C, W, and Y conjugated to CRM197 in 0.5 mL of phosphate-buffered saline, which is used to reconstitute the lyophilized MenA component. Menveo does not prevent N. meningitidis serogroup B infections. 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.

The European Commission approved a single-vial, fully liquid presentation of Menveo (Meningococcal Group A, C, W-135, and Y conjugate vaccine, MenACWY vaccine) in November 2024 to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W, and Y.

This single-vial presentation is now licensed for active immunization of children from 2 years to adolescents and adults. It offers healthcare providers an option that does not require reconstitution before use.

The U.S. Prescribing Information is available at this weblink. GSK Medical Information: 1-877-GSK-MI4U (1-877-475-6448). The U.S. CDC Advisory Committee on Immunization Practices (ACIP) vaccine committee reviewed the Menveo One-Vial Presentation on October 20, 2022, led by Sam Crowe, Ph.D., MPH, Work Group Lead.

Menveo Indication

Menveo is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. The U.S. CDC recommends MenACWY vaccination for children who are between 2 months and 10 years old if they:

• Have a rare type of immune disorder called a complement component deficiency
• Are taking a type of medicine called a complement inhibitor (for example, Soliris® or Ultomiris®)
• Have a damaged spleen or sickle cell disease, or their spleen has been removed
• Have HIV
• Are you traveling to or residing in countries in which serogroup A, C, W, or Y meningococcal disease is common
• Are part of a population identified to be at increased risk because of a serogroup A, C, W, or Y meningococcal disease outbreak

All 11 to 12-year-olds should get a MenACWY vaccine, with a booster shot at 16 years old.

Menveo Dosage

MENVEO is approved for use in individuals 2 through 55 years and administered as an intramuscular injection. In children initiating vaccination at 2 months of age, Menveo is to be administered as a 4-dose series at 2, 4, 6, and 12 months of age. 

Menveo Adverse Reactions

Common solicited adverse reactions among children initiating vaccination at 2 months of age and receiving the 4-dose series were tenderness and erythema at the injection site, irritability, sleepiness, persistent crying, change in eating habits, vomiting, and diarrhea at 7 months through 23 months of age and receiving the 2-dose series were tenderness and erythema at the 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 were observed among adolescents and adults following a single booster dose.

Menveo Clinical Trials

GSK's Menveo has been involved in many clinical trials.