Drug: Comvax

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.

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In clinical trials involving the administration of 7918 doses of COMVAX to 3561 healthy infants 6 weeks to 15 months of age, COMVAX was generally well tolerated. In these studies, infants received COMVAX with licensed pediatric vaccines (n=1745) or investigational vaccines (n=1816). Serious adverse experience data were available for all 3561 infants and non-serious adverse experience data were available for a subset of 1678 infants. Pivotal Immunogenicity And Safety Study In the pivotal, randomized, multicenter study, 882 infants were assigned in a 3:1 ratio to receive either COMVAX or PedvaxHIB plus RECOMBIVAX HB at separate injection sites at 2, 4, and 12-15 months of age. Children may have also received routine pediatric immunizations. The children were monitored daily for five days after each injection for injection-site and systemic adverse experiences. During this time, adverse experiences in infants who received COMVAX were generally similar in type and frequency to those observed in infants who received PedvaxHIB plus RECOMBIVAX HB. The most frequently cited events were mild, transient signs and symptoms of inflammation at the injection site (i.e., pain/soreness, erythema, and swelling/induration), somnolence, and irritability, all of which were prompted for on report cards filled out by parents of vaccinated children. Table 3 summarizes the frequencies of injection-site and systemic adverse experiences within five days of vaccination that were reported among ≥ 1.0% of children in this pivotal trial. Table 3 : Local Reactions and Systemic Complaints Within 5 Days After Injection Reported to Occur in ≥ 1.0%t of Children Given a 3-Dose Course of COMVAX Compared to These Events in Children Given Concomitant Injections of PedvaxHIB and RECOMBIVAX HB
Event Injection 1‡ Injection 2‡ Injection 3 COMVAX
(N=660)% PedvaxHIB and RECOMBIVAX HB***
(N=221)% COMVAX
(N=645)% PedvaxHIB and RECOMBIVAX HB***
(N=213)% COMVAX
(N=593)% PedvaxHIB and RECOMBIVAX HB***
(N=193)% Injection Site Reactions   Pain/Soreness* 34.5 37.6 24.3 25.8 23.9 21.2   Erythema ( > 1 in.)* 22.4 (2.7) 25.8 (2.7) 25.7 (1.4) 23.5 (3.3) 27.2 (3.0) 24.4 (1.6)   Swelling/Induration ( > 1 in.)* 27.6 (3.0) 33.5 (4.1) 30.4 (2.9) 31.0 (3.8) 27.2 (3.2) 29.5 (4.1) Systemic Complaints    Irritability* 57.0 46.6 50.7 44.1 32.2 29.0   Somnolence* 49.5 47.1 37.4 31.9 21.1 22.3   Crying      unusual, high pitched* 10.6 8.6 6.7 2.3 2.9 3.6      not otherwise specified 2.3 2.3 1.4 2.3 0.7 1.6      prolonged ( > 4 hrs.)* 2.4 2.3 0.8 1.4 0.2 0   Anorexia 3.9 2.3 2.0 0.9 0.8 0.5   Vomiting 2.1 1.8 2.5 0.9 1.0 1.6   Otitis media 0.5 0 2.0 1.4 2.7 1.6   Fever (°F, rectal equiv.)**     101.0-102.9 14.2 11.9 13.8 12.2 10.5 6.4      ≥ 103.0 0.8 0 1.6 1.4 2.7 4.3   Diarrhea 1.7 1.8 0.8 0.9 2.2 0.5   Upper respiratory infection  0.5 0.5 1.1 0.9 1.3 0.5   Rash 0.8 0 0.9 0 0.8 0.5   Rhinorrhea 0.2 0 1.1 0.9 1.3 2.1   Respiratory congestion  0.6 0.5 1.2 0.9 0.3 0.5   Cough 0.2 0 0.9 0.5 0.2 1.0   Candidiasis, oral 0.3 0.5 0.8 0 0.2 0   Rash, diaper 0.5 0.5 0.5 0.9 0.2 0 † Overall frequency of each event listed above is ≥ 1% even though the frequency after a given dose may be < 1%.
‡ Most children received DTP and OPV concomitantly with the first two doses of COMVAX or PedvaxHIB and RECOMBIVAX HB.
* Events prompted for on Vaccination Report Card given to parents/guardians of vaccinees.
** N for injections 1, 2, and 3 equals 655, 639, and 588, respectively, for COMVAX; N for injections 1, 2, and 3 equals 218, 213, and 187, respectively, for PedvaxHIB and RECOMBIVAX HB.
*** Injection site reactions for PedvaxHIB and RECOMBIVAX HB based on occurrence with either of the monovalent components. Infants Previously Vaccinated With Hepatitis B Vaccine In a group of infants (N=126) given a three-dose course of COMVAX after previously receiving a dose of Hepatitis B Vaccine (Recombinant) at or shortly after birth, the type, frequency, and severity of adverse experiences did not appear to be greater than those observed in infants in the pivotal study who did not receive hepatitis B vaccine at birth. Infants 6 Weeks To 15 Months Of Age In clinical trials, 3285 doses of COMVAX were administered to 1678 infants who were monitored for injection-site and systemic adverse experiences from Days 0 to 5 after each injection of vaccine. Of these, 855 infants had safety data following vaccination at approximately 2 months of age, 836 infants at approximately 4 months of age and 1573 infants at 12 to 15 months of age. The most frequently reported adverse experiences ( ≥ 1% of subjects for at least one injection), without regard to causality are listed in decreasing order of frequency within each body system: Injection Site Reactions: Pain/tenderness/soreness, swelling/induration, erythema; Body as a Whole: Fever; Digestive System: Anorexia, diarrhea, vomiting; Nervous System/Psychiatric: Irritability, somnolence, crying; Respiratory System: Upper respiratory infection, rhinorrhea, cough, rhinitis; Skin: Rash; Special Senses: Otitis media. Post-Marketing Experience As with any vaccine, there is the possibility that broad use of COMVAX could reveal adverse experiences not observed in clinical trials. The following additional adverse reactions have been reported with the use of the marketed vaccine. Hypersensitivity Anaphylaxis, angioedema, urticaria, erythema multiforme Hematologic Thrombocytopenia Nervous System Seizure, febrile seizures Potential Adverse Effects In addition, a variety of adverse effects have been reported with marketed use of either PedvaxHIB or RECOMBIVAX HB in infants and children through 71 months of age. These adverse effects are listed below. PedvaxHIB Hematologic/Lymphatic Lymphadenopathy Skin Sterile injection-site abscess; pain at the injection site RECOMBIVAX HB Hypersensitivity Symptoms of hypersensitivity including reports of rash, pruritus, edema, arthralgia, dyspnea, hypotension, and ecchymoses Cardiovascular System Tachycardia; syncope Digestive System Elevation of liver enzymes Hematologic Increased erythrocyte sedimentation rate Musculoskeletal System Arthritis Nervous System Bell's Palsy; Guillain-Barre Syndrome Psychiatric/Behavioral Agitation; somnolence; irritability Skin Stevens-Johnson Syndrome; alopecia Special Senses Conjunctivitis; visual disturbances Adverse Event Reporting Patients, parents and guardians should be instructed to report any serious adverse reactions to their health-care provider who in turn should report such events to the U.S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS), 1-800-822-7967. The healthcare provider should inform the parent or guardian of the National Vaccine Injury Compensation Program (NVICP), 1-800-338-2382. Read the Comvax (haemophilus b conjugate and hepatitis b vaccine) Side Effects Center for a complete guide to possible side effectsLearn More »

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FOR INTRAMUSCULAR ADMINISTRATION Do not inject intravenously, intradermally, or subcutaneously. Recommended Schedule Infants 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 vaccine Children 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 COMVAX Vaccination 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 Vaccines Since 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®*), 2) polyribosylribitol phosphate-tetanus toxoid conjugate (PRP-T) (ActHIB®* and OmniHIB *), 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

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Deferral of immunization may be considered in individuals receiving immunosuppressive therapy. Read the Comvax Drug Interactions Center for a complete guide to possible interactions Learn More »

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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. Use With Other Vaccines 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).

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Hypersensitivity to yeast or any component of the vaccine. The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and on the etiology of the disease. The ACIP has recommended that immunization should be delayed during the course of an acute febrile illness.63 All vaccines can be administered to persons with minor illnesses such as diarrhea, mild upper-respiratory infection with or without low-grade fever, or other low-grade febrile illness. Persons with moderate or severe febrile illness should be vaccinated as soon as they have recovered from the acute phase of the illness. REFERENCES 63. Centers for Disease Control. MMWR 43(RR-1): 1994.Last reviewed on RxList: 8/22/2014
This monograph has been modified to include the generic and brand name in many instances.

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No information provided.

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No. 4898 — COMVAX is supplied as 7.5 mcg PRP polysaccharide conjugated to approximately 125 mcg OMPC and 5 mcg HBsAg in a box of 10 single dose vials. NDC 0006-4898-00. Storage Store vaccine at 2-8°C (36-46°F). Storage above or below the recommended temperature may reduce potency. DO NOT FREEZE since freezing destroys potency. REFERENCES 32. Centers for Disease Control. MMWR 40(RR-1):1-25, 1991. 33. Committee on Infectious Disease. Update Pediatrics 88(1): 169-172, 1991. 50. Universal Hepatitis B Immunization, Committee on Infectious Diseases. Pediatr 89(4): 795-800, 1992. 62. Centers for Disease Control. MMWR 38(13): 205-228, 1989. 63. Centers for Disease Control. MMWR 43(RR-1): 1994. 65. Centers for Disease Control. MMWR 46(54): 74, 1998. 66. Centers for Disease Control. MMWR 47(1): 9, 1998. Manuf. and Dist. by: Merck & Co., Inc., Whitehouse Station, NJ 08889, USA Last reviewed on RxList: 8/22/2014
This monograph has been modified to include the generic and brand name in many instances.

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General General care is to be taken by the health-care provider for the safe and effective use of this product. As for any vaccine, adequate treatment provisions, including epinephrine, should be available for immediate use should an anaphylactic or anaphylactoid reaction occur. Use caution when vaccinating latex-sensitive individuals since the vial stopper contains dry natural latex rubber that may cause allergic reactions. As reported with Haemophilus b Polysaccharide Vaccine and another Haemophilus b Conjugate Vaccine, cases of Haemophilus b disease may occur in the week after vaccination, prior to the onset of the protective effects of the vaccines. The packaging stopper of this product contains natural rubber latex which may cause allergic reactions. Laboratory Test Interactions Sensitive tests (e.g., Latex Agglutination Kits) may detect PRP derived from the vaccine in the urine of some vaccinees for at least 30 days following vaccination with lyophilized PedvaxHIB58; in clinical studies with lyophilized PedvaxHIB, such children demonstrated a normal immune response to the vaccine. It is not known whether antigenuria will occur after vaccination with COMVAX. Carcinogenesis, Mutagenesis, Impairment Of Fertility COMVAX has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility. Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with COMVAX. It is also not known whether COMVAX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. COMVAX is not recommended for use in women of childbearing age. Pediatric Use Safety and effectiveness of COMVAX in infants below the age of 6 weeks and above the age of 15 months have not been established. However, studies have demonstrated that PedvaxHIB is safe and immunogenic when administered to infants and children up to the age of 71 months and RECOMBIVAX HB is safe and immunogenic in persons of all ages. COMVAX should not be used in infants younger than 6 weeks of age because this will lead to a reduced anti-PRP response and may lead to immune tolerance (impaired ability to respond to subsequent exposure to the PRP antigen).59-61 Infants born to HBsAg-positive mothers should not receive COMVAX but instead 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]). (See DOSAGE AND ADMINISTRATION.) Geriatric Use This vaccine is NOT recommended for use in adult populations. REFERENCES 58. Goep, J.G., et al. Pediatr Infect Dis J 1(1): 2-5, 1992. 59. Keyserling, H.L., et al. Program and Abstracts of the 30th ICAAC, 1990. (Abst. 63). 60. Ward, J.I., et al. Program and Abstracts of the 32nd ICAAC, 1992. (Abst. 984). 61. Lieberman, J.M., et al. Infect Dis, 199 (Abst.1028). 68. Centers for Disease Control. MMWR 42(RR-4): 1-18, April 9, 1993. Last reviewed on RxList: 8/22/2014
This monograph has been modified to include the generic and brand name in many instances.

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