Actions of Quinvaxem in details
Pharmacotherapeutic Group: Vaccines, combined bacterial and viral vaccines. ATC Code: J07CA09.
Pharmacology: Pharmacodynamics: The primary vaccination schedules that have been used are: 6, 10, 14 weeks with and without Hepatitis B (Quinvaxem) vaccination at birth; 2, 3, 4 months without Hepatitis B (Quinvaxem) vaccination at birth; 2, 4, 6 months with and without Hepatitis B (Quinvaxem) vaccination at birth.
Results obtained for each of the components are summarized in Tables 1 and 2.
Vaccine efficacy of the acellular Pertussis (Quinvaxem) (aP) antigens contained in Quinvaxem against the most severe World Health Organization-defined typical Pertussis (Quinvaxem) (≥21 days of paroxysmal cough) is documented in a randomized, double-blind study among infants with a 3-dose primary series using a Diphtheria (Quinvaxem), Tetanus (Quinvaxem), Pertussis (Quinvaxem) (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 aP antigens contained in Quinvaxem to reduce Pertussis (Quinvaxem) incidence and control Pertussis (Quinvaxem) disease in the childhood has been demonstrated in a 10-year national Pertussis (Quinvaxem) surveillance on Pertussis (Quinvaxem) disease in Sweden with the pentavalent DTaP-polio vaccine/Haemophilus influenzae type B (Hib) vaccine using a 3, 5, 12 months schedule. Results of long term follow-up demonstrated a dramatic reduction of the Pertussis (Quinvaxem) incidence following the 2nd dose regardless of the vaccine used.
The vaccine effectiveness against Hib invasive disease of DTaP and Hib combination vaccines (pentavalent and hexavalent including vaccines containing the Hib antigen from Quinvaxem) has been demonstrated in Germany via an extensive (over 5 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.
Preclinical Safety Data: Nonclinical 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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Information checked by Dr. Sachin Kumar, MD Pharmacology
