Comvax
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Questions & Answers
Side Effects & Adverse Reactions
Patients who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections of the vaccine (see CONTRAINDICATIONS).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
COMVAX is indicated for vaccination against invasive disease caused by Haemophilus influenzae type b and against infection caused by all known subtypes of hepatitis B virus in infants 6 weeks to 15 months of age born of HBsAg negative mothers.
Infants born to HBsAg positive mothers should receive Hepatitis B Immune Globulin and Hepatitis B Vaccine (Recombinant) at birth and should complete the hepatitis B vaccination series given according to a particular schedule (see manufacturer's circular for Hepatitis B Vaccine [Recombinant]).
Infants born to mothers of unknown HBsAg status should receive Hepatitis B Vaccine (Recombinant) at birth and should complete the hepatitis B vaccination series given according to a particular schedule (see manufacturer's circular for Hepatitis B Vaccine [Recombinant]).
Vaccination with COMVAX should ideally begin at approximately 2 months of age or as soon thereafter as possible. In order to complete the three-dose regimen of COMVAX, vaccination should be initiated no later than 10 months of age. Infants in whom vaccination with a PRP-OMPC-containing product (i.e., PedvaxHIB, COMVAX) is not initiated until 11 months of age do not require three doses of PRP-OMPC; however, three doses of an HBsAg-containing product are required for complete vaccination against hepatitis B, regardless of age. For infants and children not vaccinated according to the recommended schedule see DOSAGE AND ADMINISTRATION.
COMVAX will not protect against invasive disease caused by Haemophilus influenzae other than type b or against invasive disease (such as meningitis or sepsis) caused by other microorganisms. COMVAX will not prevent hepatitis caused by other viruses known to infect the liver. Because of the long incubation period for hepatitis B, it is possible for unrecognized infection to be present at the time the vaccine is given. The vaccine may not prevent hepatitis B in such patients.
As with other vaccines, COMVAX may not induce protective antibody levels immediately following vaccination and may not result in a protective antibody response in all individuals given the vaccine.
Immunogenicity results from open-labeled studies indicate that COMVAX can be administered concomitantly with DTP, DTaP, OPV, IPV, M-M-R II, and VARIVAX using separate sites and syringes for injectable vaccines (see CLINICAL PHARMACOLOGY).
History
There is currently no drug history available for this drug.
Other Information
COMVAX® [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine] is a sterile bivalent vaccine made of the antigenic components used in producing PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] and RECOMBIVAX HB® [Hepatitis B Vaccine (Recombinant)]. These components are the Haemophilus influenzae type b capsular polysaccharide [polyribosylribitol phosphate (PRP)] that is covalently bound to an outer membrane protein complex (OMPC) of Neisseria meningitidis and hepatitis B surface antigen (HBsAg) from recombinant yeast cultures.
Haemophilus influenzae type b and Neisseria meningitidis serogroup B are grown in complex fermentation media. The primary ingredients of the phenol-inactivated fermentation medium for Haemophilus influenzae include an extract of yeast, nicotinamide adenine dinucleotide, hemin chloride, soy peptone, dextrose, and mineral salts and for Neisseria meningitidis include an extract of yeast, amino acids and mineral salts. The PRP is purified from the culture broth by purification procedures which include ethanol fractionation, enzyme digestion, phenol extraction and diafiltration. The OMPC from Neisseria meningitidis is purified by detergent extraction, ultracentrifugation, diafiltration and sterile filtration.
The PRP-OMPC conjugate is prepared by the chemical coupling of the highly purified PRP (polyribosylribitol phosphate) of Haemophilus influenzae type b (Haemophilus b, Ross strain) to an OMPC of the B11 strain of Neisseria meningitidis serogroup B. The coupling of the PRP to the OMPC is necessary for enhanced immunogenicity of the PRP. This coupling is confirmed by analysis of the components of the conjugate following chemical treatment which yields a unique amino acid. After conjugation, the aqueous bulk is then adsorbed onto an amorphous aluminum hydroxyphosphate sulfate adjuvant (previously referred to as aluminum hydroxide).
HBsAg is produced in recombinant yeast cells. A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast, and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain according to methods developed in the Merck Research Laboratories. The antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg. The fermentation process involves growth of Saccharomyces cerevisiae on a complex fermentation medium which consists of an extract of yeast, soy peptone, dextrose, amino acids and mineral salts.
The HBsAg protein is released from the yeast cells by mechanical cell disruption and detergent extraction, and purified by a series of physical and chemical methods, which includes ion and hydrophobic chromatography, and diafiltration. The purified protein is treated in phosphate buffer with formaldehyde and then coprecipitated with alum (potassium aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum hydroxyphosphate sulfate. The vaccine contains no detectable yeast DNA, and 1% or less of the protein is of yeast origin.
The individual PRP-OMPC and HBsAg adjuvanted bulks are combined to produce COMVAX. Each 0.5 mL dose of COMVAX is formulated to contain 7.5 mcg PRP conjugated to approximately 125 mcg OMPC, 5 mcg HBsAg, approximately 225 mcg aluminum as amorphous aluminum hydroxyphosphate sulfate, and 35 mcg sodium borate (decahydrate) as a pH stabilizer, in 0.9% sodium chloride. The vaccine contains not more than 0.0004% (w/v) residual formaldehyde.
The potency of the PRP-OMPC component is measured by quantitating the polysaccharide concentration by an HPLC method. The potency of the HBsAg component is measured relative to a standard by an in vitro immunoassay.
The product contains no preservative.
COMVAX is a sterile suspension for intramuscular injection.
Sources
Comvax Manufacturers
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Merck Sharp & Dohme Corp.
![Comvax (Haemophilus B Conjugate (Meningococcal Protein Conjugate) And Hepatitis B (Recombinant) Vaccine) Injection, Suspension [Merck Sharp & Dohme Corp.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Comvax | Merck Sharp & Dohme Corp.
FOR INTRAMUSCULAR ADMINISTRATION
Do not inject intravenously, intradermally, or subcutaneously.
Recommended ScheduleInfants born to HBsAg negative mothers should be vaccinated with three 0.5 mL doses of COMVAX, ideally at 2, 4, and 12-15 months of age. If the recommended schedule cannot be followed, the interval between the first two doses should be at least six weeks and the interval between the second and third dose should be as close as possible to eight to eleven months.
Infants born to HBsAg-positive mothers should receive Hepatitis B Immune Globulin and Hepatitis B Vaccine (Recombinant) at birth and should complete the hepatitis B vaccination series given according to a particular schedule (see manufacturer's circular for Hepatitis B Vaccine [Recombinant]).
Infants born to mothers of unknown HBsAg status should receive Hepatitis B Vaccine (Recombinant) at birth and should complete the hepatitis B vaccination series given according to a particular schedule (see manufacturer's circular for Hepatitis B Vaccine [Recombinant]).
The subsequent administration of COMVAX for completion of the hepatitis B vaccination series in infants who were born to HBsAg positive mothers and received HBIG or infants born to mothers of unknown status has not been studied.
COMVAX should not be administered to any infant before the age of 6 weeks.
Modified Schedules Children previously vaccinated with one or more doses of either hepatitis B vaccine or Haemophilus b conjugate vaccineChildren who receive one dose of hepatitis B vaccine at or shortly after birth may be administered COMVAX on the schedule of 2, 4, and 12-15 months of age. There are no data to support the use of a three-dose series of COMVAX in infants who have previously received more than one dose of hepatitis B vaccine. However, COMVAX may be administered to children otherwise scheduled to receive concurrent RECOMBIVAX HB and PedvaxHIB.
Children not vaccinated according to recommended schedule for COMVAXVaccination schedules for children not vaccinated according to the recommended schedule should be considered on an individual basis. The number of doses of a PRP-OMPC-containing product (i.e., COMVAX, PedvaxHIB) depends on the age that vaccination is begun. An infant 2 to 10 months of age should receive three doses of a product containing PRP-OMPC. An infant 11 to 14 months of age should receive two doses of a product containing PRP-OMPC. A child 15 to 71 months of age should receive one dose of a product containing PRP-OMPC. Infants and children, regardless of age, should receive three doses of an HBsAg-containing product.
COMVAX is for intramuscular injection. The anterolateral thigh is the recommended site for intramuscular injection in infants. Data suggests that injections given in the buttocks frequently are given into fatty tissue instead of into muscle. Such injections have resulted in a lower seroconversion rate (for hepatitis B vaccine) than was expected.
Injection must be accomplished with a needle long enough to ensure intramuscular deposition of the vaccine. The ACIP has recommended that for intramuscular injections, the needle should be of sufficient length to reach the muscle mass itself. In a clinical trial with COMVAX (see CLINICAL PHARMACOLOGY, Antibody Responses to COMVAX in Infants Not Previously Vaccinated with Hib or Hepatitis B Vaccine, Table 1) vaccination was accomplished with a needle length of 5/8 inches in accordance with ACIP recommendations in effect at that time.{62} ACIP currently recommends that needles of longer length (7/8 to 1 inch) be used.{63}
The vaccine should be used as supplied; no reconstitution is necessary.
Shake well before withdrawal and use. Thorough agitation is necessary to maintain suspension of the vaccine.
Parenteral drug products should be inspected visually for extraneous particulate matter and discoloration prior to administration whenever solution and container permit. After thorough agitation, COMVAX is a slightly opaque, white suspension.
It is important to use a separate sterile syringe and needle for each patient to prevent transmission of infectious agents from one person to another.
Interchangeability of COMVAX and Licensed Haemophilus b Conjugate Vaccines or Recombinant Hepatitis B VaccinesSince 1990, the Advisory Committee on Immunization Practices (ACIP) and the Committee on Infectious Diseases of the American Academy of Pediatrics (AAP) have recommended routine immunization of infants starting at 2 months of age with a polysaccharide-protein conjugate vaccine to prevent invasive Hib disease.{32,33}
Three Hib vaccines are licensed for infant vaccination: 1) oligosaccharide conjugate Hib vaccine (HbOC) (HibTITER®1), 2) polyribosylribitol phosphate-tetanus toxoid conjugate (PRP-T) (ActHIB®1 and OmniHIB®1), and 3) Haemophilus b conjugate vaccine (meningococcal protein conjugate) (PRP-OMPC) (PedvaxHIB). According to the ACIP, these products are now considered interchangeable for primary as well as booster vaccination.{66}
Because vaccination recommendations limited to high-risk individuals have failed to substantially lower the overall incidence of hepatitis B infection, both the Advisory Committee on Immunization Practices (ACIP) and the Committee on Infectious Diseases of the American Academy of Pediatrics (AAP) have endorsed universal infant immunization as part of a comprehensive strategy for the control of hepatitis B infection.{32,50}
1HibTITER is a registered trademark of Lederle Laboratories, ActHIB is a registered trademark of Aventis Pasteur Inc. and OmniHIB is a registered trademark of GlaxoSmithKline.
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