Haemophilus b conjugate vaccine clinical pharmacology

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Haemophilus b conjugate vaccine
HIBERIX® FDA Package Insert
Description
Clinical Pharmacology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]


Clinical Pharmacology

Mechanism of Action

Haemophilusinfluenzae is a gram-negative coccobacillus. Most strains of H. influenzae that cause invasive disease are type b. H. influenzaetype b can cause invasive disease such as sepsis and meningitis.

Specific levels of antibodies to polyribosyl-ribitol-phosphate (anti-PRP) have been shown to correlate with protection against invasive disease due to H. influenzae type b. Based on data from passive antibody studies2 and a clinical efficacy study with unconjugated Haemophilus b polysaccharide vaccine3, an anti-PRP concentration of 0.15 mcg/mL has been accepted as a minimal protective level. Data from an efficacy study with unconjugated Haemophilus b polysaccharide vaccine indicate that an anti-PRP concentration of ≥1.0 mcg/mL predicts protection through at least a 1-year period.4,5 These antibody levels have been used to evaluate the effectiveness of Haemophilus b Conjugate Vaccines, including HIBERIX.[1]


References

  1. "HIBERIX (HAEMOPHILUS B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAXOSMITHKLINE BIOLOGICALS SA]".

Adapted from the FDA Package Insert.