Menveo Vaccine Clinical Trials, Dosage, Efficacy 

GSK's Menveo helps protect appropriate adolescent patients with a primary and booster dose of MENVEO. 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 serogroup 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 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 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 among adolescents and adults were observed following a single booster dose.

Menveo Vaccine News

November 27, 2024—Philip Dormitzer, GSK Head of Global Vaccines Research & Development, said: "As a leader in meningococcal vaccines, GSK is dedicated to finding innovative solutions that simplify immunization and support vaccine uptake. We remain committed to safeguarding individuals from bacterial meningitis and will persist in our efficacy in preventing devastating disease among at-risk populations in the European Union."

October 17, 2022 - GSK announced that the US FDA had approved a new presentation of Menveo for individuals aged 10 to 55 years to help prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W. The Menveo one-vial presentation now comes in a ready-to-use single vial, giving healthcare providers a more convenient option.

August 18, 2022—Florida Health departments offer meningococcal vaccines for free. The state has been experiencing an outbreak this year, recording over 50 cases. February 9, 2022 - GSK reported that during 2021, Menveo sales were up 3% AER 9% CER to £272 million, primarily driven by 2020 cohort catch-up vaccinations and 2021 higher demand, as well as increased market share in the U.S.

Menveo Clinical Trials

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