haemophilus b conjugate (meningococcal protein conjugate)/hepatitis b (recombinant) vaccine [IM]

Adult Dosing

Adult dosing is not applicable

Pediatric Dosing

Immunization

Infants 6 wks-15 months

For infants born to HBsAg-negative mothers, give 0.5 mL IM (anterolateral thigh) x3 at 2, 4, and 12-15 months of age
Notes:

Interval should be >6 wks between doses 1-2 and 8-11 months between doses 2-3
Infants born to HBsAg-positive mothers should receive Hepatitis B Immune Globulin and Hepatitis B Vaccine (Recombinant) at birth and then complete the hepatitis B vaccination series as per a particular schedule
Infants born to mothers of unknown HBsAg status should receive Hepatitis B Vaccine (Recombinant) at birth and then complete the hepatitis B vaccination series as per a particular schedule

[Outline]

Adult Dosing
Pediatric Dosing

Indications ⬆ ⬇

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

Contraindications ⬆ ⬇

Hypersensitivity to any of the ingredients of the product
Hypersensitivity to meningococcal protein
Hypersensitivity to yeast
Acute febrile illness

Black Box Warnings ⬆ ⬇

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

Hepatic impairment: Dose adjustments not defined

Warnings/Precautions ⬆ ⬇

See Supplemental Patient Information

Do not administer further injections of the vaccine in patients who develop symptoms suggestive of hypersensitivity after an injection
Adequate treatment provisions, including epinephrine, should be available for immediate use should an anaphylactic or anaphylactoid reaction occur
Use of vials and other products containing natural rubber latex and dry natural latex rubber may cause allergic reactions in latex-sensitive individuals
Cases of Haemophilus b disease may occur in the week after vaccination, prior to the onset of the protective effects of the vaccines
Prior to injecting vaccine, determine the current health status and previous vaccination history of the vaccine
Caution should be exercised in infants with bleeding disorders such as hemophilia or thrombocytopenia, with steps taken to avoid the risk of hematoma following the injection
Avoid injection of a blood vessel
The expected immune response may not be obtained if used in persons with malignancies or those receiving immunosuppressive therapy or who are otherwise immunocompromised
Vaccination can be given in the presence of HIV infection

Supplemental Patient Information

Inform the patient, parent or guardian about the benefits and risks associated with vaccination

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:C

Breastfeeding: Safety unknown.

Adverse Reactions ⬆ ⬇

CNS: Somnolence, seizures, febrile seizures, Bell palsy, Guillain-Barre syndrome
CV: Tachycardia, syncope
PSYCHIATRY: Irritability
GI: Vomiting, diarrhea
HYPERSENSITIVITY: Anaphylaxis, angioedema, Stevens-Johnson syndrome
DERM: Erythema multiforme, alopecia
HEMA: Thrombocytopenia, increased ESR
METABOLIC: Elevated LFTs, anorexia
LOCAL: Injection site reactions such as pain/soreness, erythema, swelling/induration
MISC: Persistent unusual crying, lymphadenopathy, fever

Clinical Pharmacology ⬆ ⬇

Haemophilus b conjugate

Vaccine; active against invasive disease caused by Haemophilus influenzae type b
Metabolism: Unknown
Excretion: Unknown
Half-life: Unknown

Hepatitis b (recombinant)

Vaccine; active against infection caused by all known subtypes of hepatitis B virus
Metabolism: Unknown
Excretion: Unknown
Half-life: Unknown

Brands and Availability ⬆ ⬇

US Trade Name(s)

Comvax

US Availability

Comvax [haemophilus b conjugate (meningococcal protein conjugate)/hepatitis b (recombinant)]

INJ: 7.5 mcg polyribosylribitol phosphate (PRP) polysaccharide conjugated to 125 mcg outer membrane protein complex (OMPC)/5 mcg hepatitis B surface antigen (HBsAg)

Canadian Trade Name(s)

Canadian Availability

UK Trade Name(s)

UK Availability

Australian Trade Name(s)

Comvax

Australian Availability