Comvax

Comvax

INDICATIONS

COMVAX (haemophilus b conjugate and hepatitis b vaccine) 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 (haemophilus b conjugate and hepatitis b vaccine) 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 (haemophilus b conjugate and hepatitis b vaccine) , 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 (haemophilus b conjugate and hepatitis b vaccine) ) 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 (haemophilus b conjugate and hepatitis b vaccine) 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 (haemophilus b conjugate and hepatitis b vaccine) 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 (haemophilus b conjugate and hepatitis b vaccine) 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 (haemophilus b conjugate and hepatitis b vaccine) 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).

DOSAGE AND ADMINISTRATION

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 (haemophilus b conjugate and hepatitis b vaccine) , 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 (haemophilus b conjugate and hepatitis b vaccine) 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 (haemophilus b conjugate and hepatitis b vaccine) 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 (haemophilus b conjugate and hepatitis b vaccine) 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 (haemophilus b conjugate and hepatitis b vaccine) in infants who have previously received more than one dose of hepatitis B vaccine. However, COMVAX (haemophilus b conjugate and hepatitis b vaccine) may be administered to children otherwise scheduled to receive concurrent RECOMBIVAX HB and PedvaxHIB.

Children not vaccinated according to recommended schedule for COMVAX (haemophilus b conjugate and hepatitis b vaccine)

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 (haemophilus b conjugate and hepatitis b vaccine) , 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 (haemophilus b conjugate and hepatitis b vaccine) 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 (haemophilus b conjugate and hepatitis b vaccine) 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 (haemophilus b conjugate and hepatitis b vaccine) 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 (haemophilus b conjugate and hepatitis b vaccine) 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

HOW SUPPLIED

No. 4898 — COMVAX (haemophilus b conjugate and hepatitis b vaccine) 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.

63. Centers for Disease Control. MMWR 43(RR-1): 1994.

62. Centers for Disease Control. MMWR 38(13): 205-228, 1989.

66. Centers for Disease Control. MMWR 47(1): 9, 1998.

Manuf. and Dist. by: MERCK&CO., INC, Whitehouse Station, NJ 08889, USA. Issued August 2004.

Last reviewed on RxList: 3/4/2009
This monograph has been modified to include the generic and brand name in many instances.

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