Haemophilus b conjugate vaccine clinical pharmacology: Difference between revisions
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<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = HIBERIX (HAEMOPHILUS B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAXOSMITHKLINE BIOLOGICALS SA] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=745ff8df-1618-4b76-9aa1-6f42752c0dda | publisher = | date = | accessdate = }}</ref> | ==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.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = HIBERIX (HAEMOPHILUS B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAXOSMITHKLINE BIOLOGICALS SA] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=745ff8df-1618-4b76-9aa1-6f42752c0dda | publisher = | date = | accessdate = }}</ref> | |||
Latest revision as of 14:42, 9 January 2014
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
Adapted from the FDA Package Insert.