Haemophilus influenzae type b and Meningococcal (Groups A and Y) vaccine - Menhibrix
Status: approved by FDA in June 2012
Organizations involved:
GlaxoSmithKline – Manuf.; R&D; Tech.; World mark.
Cross ref.: See the related component vaccines from GSK.
Description:
Menhibrix (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine) is a lyophillized (freeze-dried) formulation combining: a) a multi-valent N. menngitidis and H. influenzae conjugate polysaccharide vaccine. The vaccine contains individually cultured, inactivated, and purified Neisseria meningitidis strain types C and Y (with no A or W-135) capsular polysaccharides chemically conjugated to tetanus toxic derived from Clostridium tetani bacteria plus b) a monovalent Haemophilus influenzae vaccine -- Haemophilus b capsular polysaccharide (polyribosyl-ribitol-phosphate [PRP]).
The Neisseria meningitidis C and Y strains are grown in semi-synthetic media and undergo heat inactivation and purification.
The PRP is a high molecular weight polymer prepared from the Haemophilus influenzae type b strain 20,752 grown in a synthetic medium that undergoes heat inactivation and purification.
The tetanus toxin is prepared from Clostridium tetani grown in a semi-synthetic medium, detoxified with formaldehyde and purified. Each capsular polysaccharide is individually covalently bound to the inactivated tetanus toxoid. After purification, the conjugates are lyophilized in the presence of sucrose as a stabilizer. The diluent for Menhibrix is a sterile saline solution (0.9% sodium chloride) supplied in vials.
Memhibrix is packaged as a solution for injection as a single-dose vial of lyophilized vaccine to be reconstituted with the accompanying vial of saline diluent. A single dose after reconstitution is 0.5 mL. After Memhibrix is reconstituted with the saline diluent, each 0.5-mL dose is formulated to contain 5 mcg of purified Neisseria meningitidis C capsular polysaccharide conjugated to approximately 5 mcg of tetanus toxoid, 5 mcg of purified Neisseria meningitidis Y capsular polysaccharide conjugated to approximately 6.5 mcg of tetanus toxoid, and 2.5 mcg of purified Haemophilus b capsular polysaccharide conjugated to approximately 6.25 mcg of tetanus toxoid. Each dose also contains 96.8 mcg of Tris (trometamol)-HCl, 12.6 mg of sucrose, and ≤0.72 mcg of residual formaldehyde. MENHIBRIX does not contain any antimicrobial preservatives. The vial stoppers do not contain latex. Memhibrix is stored refrigerated [between 2° and 8°C (36° and 46°F)].
Nomenclature: Hib-MenCY vaccine [BIO]; Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine [FDA]; Haemophilus influenzae type b and Meningococcal (Groups A and Y) vaccine [SY]; NDC 58160-809-05 and NDC 58160-813-05 [NDC]
Companies:
Menhibrix was developed and is manufactured by GlaxoSmithKline Biological, Rixensart, Belgium, CBER/FDA est. no. 1617, with GSK having worldwide marketing rights.
FDA class: Biologic BLA
Approvals: Date = 20120614, full BLA
Indications: [insert not yet available]
Indications: [Full text of the "INDICATIONS AND USAGE' section of product insert/labeling
Status: The Menhibrix BLA received a complete response letter (CRL) in 2012. The BLA was approved on June 14, 2012.
The time from BLA submission to approval was 34.1
months, with 3 approval cycles. Somehow, FDA claims "PDUFA target date met: Yes."
Medical: Haemophilus influenzae type b and meningococcal (Groups A and Y) bacteria can infect the bloodstream causing sepsis, and the lining that surrounds the brain and spinal cord causing meningitis. In young children, Neisseria meningitidis and Haemophilus influenzae type b are important causes of bacterial meningitis.
Menhibrix is a combination vaccine that can be used to prevent potentially life-threatening Hib disease and two types of meningococcal disease in children, the first of this combination to receive approval. It is also the first meningococcal vaccine that can be given starting as young as six weeks of age,”
Menhibrix is given as a four-dose series at 2, 4, 6 and 12 through 15 months of age. The first dose may be given as early as 6 weeks of age. The fourth dose may be given as late as 18 months of age.
Trials: In support of the BLA, the safety of Menhibrix was evaluated in about 7,500 infants and toddlers in the U.S., Mexico and Australia. Common adverse reactions reported after administration of Menhibrix were pain, redness and swelling at the injection site, irritability and fever.
Medical: A 4-dose series, with each 0.5-mL dose given by intramuscular injection at 2, 4, 6, and 12 through 15 months of age. The first dose may be given as early as 6 weeks of age. The fourth dose may be given as late as 18 months of age.
Menhibrix is for intramuscular use only. The preferred administration site is the anterolateral aspect of the thigh for most infants younger than 1 year of age. In older children, the deltoid muscle is usually large enough for an intramuscular injection.
Companies involvement:
Full monograph
Hib-MenCY vaccine
MENHIBRIX is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzaetype b. MENHIBRIX is approved for use in children 6 weeks of age through 18 months of age
Nomenclature:
Hib-MenCY vaccine [BIO]
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine [FDA]
Haemophilus influenzae type b and Meningococcal (Groups A and Y) vaccine [SY]
NDC 58160-809-05 [NDC]
Year of approval (FDA) = 2012
Date of 1st FDA approval = 20120614
(in format YYYYMMDD)
Index Terms:
biopharmaceutical products
nonoxynol 101 (Triton N101)
vaccines, bacterial
vaccines, combination
vaccines, oral
bacterial culture <!-- bacterialculture -->
Clostridium tetani
Haemophilus influenzae b prophylaxis
Haemophilus influenzae type b capsular polysaccharide (PRP)
Neisseria meningitidis B11 strain
formaldehyde
formaldehyde
Haemophilus influenzae type b capsular polysaccharide (PRP)
lyophilized (freeze-dried)
sodium chloride
sucrose
Tetanus Toxoid Adsorbed
tripalmitin
Complement-Fixation Test
EU000 Not yet/Never filed with EU
UM001 Marketed Product in US
US200 Currently Approved in US
EM999 Not Available/Not Marketed in EU
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