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See the demonstrated safety profile of MENVEO

Immunogenicity and Safety of a Booster Dose of MENVEO

Solicited adverse reactions within 7 days following primary vaccination in individuals 11 through 18 years1

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). The methodology for evaluated solicited adverse reactions, unsolicited adverse events, and serious adverse events after a booster dose of MENVEO was similar to the primary vaccination studies. 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

Solicited adverse reactions in infant and toddler patients 2-23 months of age who received MENVEO at 2, 4, 6, and 12 months of age within 7 days after any dose1

  •    *MENVEO 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, MMRV (measles, mumps, rubella, varicella), and hepatitis A vaccines at Dose 4. Hepatitis B vaccine and rotavirus vaccines were allowed according to ACIP recommendations.1
  •   Routine vaccinations alone.1
ACIP=Advisory Committee on Immunization Practices.

Reference

  1. Prescribing 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. MENVEO is approved for use in persons aged 2 months through 55 years. MENVEO does not prevent N. meningitidis serogroup B infections.

IMPORTANT SAFETY INFORMATION FOR MENVEO

  • Severe allergic reaction (eg, anaphylaxis) after a previous dose of MENVEO, any component of this vaccine, or any other CRM197, diphtheria toxoid, or meningococcal-containing vaccine is a contraindication to administration of MENVEO
  • Appropriate medical treatment must be available should an acute allergic reaction, including an anaphylactic reaction, occur following administration of MENVEO
  • Syncope, sometimes resulting in falling injury associated with seizure-like movements, has been reported following vaccination with MENVEO. Vaccinees should be observed for at least 15 minutes after vaccine administration to prevent and manage syncopal reactions
  • Safety and effectiveness of MENVEO have not been evaluated in immunocompromised persons. If MENVEO is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be obtained
  • 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 subjects with a known history of GBS should take into account the potential benefits and risks
  • Apnea following intramuscular vaccination has been observed in some infants born prematurely. The decision about when to administer an intramuscular vaccine, including 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
  • In clinical trials evaluating a primary vaccination dose or series, 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. Common solicited adverse reactions among children initiating vaccination 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. Common solicited adverse reactions among children aged 2 years through 10 years 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. Some events were severe. In a clinical trial evaluating booster dose vaccination among adolescents and adults aged 15 through 55 years, similar rates of solicited adverse reactions were observed following a single booster dose. Common solicited adverse reactions were pain at the injection site and fatigue
  • Vaccination with MENVEO may not result in protection in all vaccine recipients

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