Hexaxim Mechanism of Action


sanofi pasteur


Zuellig Pharma
Full Prescribing Info
Pharmacotherapeutic Group: Vaccines, Bacterial and viral vaccines combined. ATC Code: J07CA09.
Pharmacology: Pharmacodynamics: Results obtained for each of the components are summarized in the tables as follows: (See Table 2 and Table 3.)

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Immune responses to Hib and pertussis antigens after 2 doses at 2 and 4 months of age: The immune responses to Hib (PRP) and pertussis antigens (PT and FHA) were evaluated after 2 doses in a subset of subjects receiving Hexaxim (N=148) at 2, 4, 6 months of age. The immune responses to PRP, PT and FHA antigens one month after a 2 doses given at 2 and 4 months of age were similar to those observed one month after 2-dose priming given at 3 and 5 months of age: anti-PRP titers ≥ 0.15 μg/ml were observed in 73.0% of individuals, anti-PT vaccine response in 97.9% of individuals and anti-FHA vaccine response in 98.6% of individuals.
Persistence of immune response: Studies on long-term persistence of vaccine induced antibodies following varying infant / toddler primary series and following Hepatitis B vaccine given at birth or not have shown maintenance of levels above the recognized protective levels or antibody thresholds for the vaccine antigens (see Table 4).
In addition, immunity against the hepatitis B component of the vaccine has been shown to persist up to 9 years of age after a primary series consisting of one dose of Hepatitis B vaccine given at birth followed by a 3-dose infant series at 2, 4, and 6 months of age without a toddler booster where 49.3% of vaccinees had antibodies ≥ 10 mIU/ml with geometric mean concentrations at 13.3 (95% CI: 8.82 – 20.0) mIU/ml. Immune memory against Hepatitis B had been demonstrated by the presence of an anamnestic response to a challenge Hepatitis B vaccination at the age of 9 years in 93% of vaccinees with development of geometric mean concentrations at 3692 (95% CI: 1886 – 7225) mIU/ml after vaccination. (See Table 4.)

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Efficacy and effectiveness in protecting against pertussis: Vaccine efficacy of the acellular pertussis (aP) antigens contained in Hexaxim against the most severe WHO-defined typical pertussis (≥ 21 days of paroxysmal cough) is documented in a randomised double-blind study among infants with a 3 dose primary series using a DTaP vaccine in a highly endemic country (Senegal). The need for a toddler booster dose was seen in this study. The long term capability of the acellular pertussis (aP) antigens contained in Hexaxim to reduce pertussis incidence and control pertussis disease in the childhood has been demonstrated in a 10-year national pertussis surveillance on pertussis disease in Sweden with the pentavalent DTaP-IPV/Hib vaccine using a 3, 5, 12 months schedule. Results of long term follow-up demonstrated a dramatic reduction of the pertussis incidence following the second dose regardless of the vaccine used.
Effectiveness in protecting against Hib invasive disease: The vaccine effectiveness against Hib invasive disease of DTaP and Hib combination vaccines (pentavalent and hexavalent including vaccines containing the Hib antigen from Hexaxim) has been demonstrated in Germany via an extensive (over five years follow-up period) post-marketing surveillance study. The vaccine effectiveness was of 96.7% for the full primary series, and 98.5% for booster dose (irrespective of priming).
Pharmacokinetics: No pharmacokinetic studies have been performed.
Toxicology: Preclinical safety data: Non-clinical data reveal no special hazard for humans based on conventional repeat dose toxicity and local tolerance studies.
At the injection sites, chronic histological inflammatory changes were observed, that are expected to have a slow recovery.
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