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Comvax Vaccine Description
Comvax Vaccine - Clinical Pharmacology
Haemophilus influenzae type b Disease Prior to the introduction of Haemophilus b conjugate vaccines, Haemophilus influenzae type b (Hib) was the most frequent cause of bacterial meningitis and a leading cause of serious, systemic bacterial disease in young children worldwide.{1-4} Hib disease occurred primarily in c…
Prevention of Hib Disease with Vaccine An important virulence factor of the Hib bacterium is its polysaccharide capsule (PRP). Antibody to PRP (anti-PRP) has been shown to correlate with protection against Hib disease.{3,21} While the anti-PRP level associated with protection using conjugated vaccines has not yet been deter…
COMVAX is indicated for vaccination against invasive disease caused by Haemophilus influenzaetype 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 …
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 wit…
Patients who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections of the vaccine (see CONTRAINDICATIONS).
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 cautio…
Instructions to Health-care Provider The health-care provider should determine the current health status and previous vaccination history of the vaccinee. The health-care provider should question the patient, parent or guardian about reactions to a previous dose of COMVAX, PedvaxHIB or other Haemophilus b conjugate v…
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 exp…
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. NDC0006-4898-00.