Infanrix hexa, administered intramuscularly, is a
diphtheria,
tetanus, acellular
pertussis,
hepatitis B (HBV), inactivated
poliomyelitis and Haemophilus influenzae type b (Hib)
conjugate vaccine, indicated for primary and booster vaccination of infants.
Infanrix hexa should be administered as a two- or three-dose primary vaccination course in infants aged < or =6 months, followed by booster vaccination between 11 and 18 months of age, with an interval of at least 6 months between the last dose of primary vaccination and the booster dose. This spotlight reviews the immunogenicity and protective effectiveness, as well as the reactogenicity and safety of
Infanrix hexa.
Infanrix hexa as primary and booster vaccination was safe and highly immunogenic for all its component
toxoids/
antigens in infants aged <2 years, regardless of vaccination schedules. Its immunogenicity and safety profiles were generally similar to those of currently available
vaccines, the
diphtheria,
tetanus and acellular
pertussis-based
pentavalent vaccines plus monovalent HBV or Hib
vaccines. In large clinical studies,
Infanrix hexa elicited a strong immune response against
vaccine toxoids/
antigens, as indicated by high seroprotection/seropositivity/
vaccine response rates and geometric mean titers. Moreover,
antibodies against
vaccine toxoids/
antigens persisted for up to a mean of approximately 6 years after booster vaccination, and the
vaccine induced long-term immune memory against
hepatitis B surface antigen and Hib
antigen. A strong immune response against
Infanrix hexa toxoids/
antigens after primary vaccination was also induced in infants who had received a dose of HBV
vaccine at birth and in pre-term infants, although the response in the latter group was somewhat lower than that in full-term infants. In addition, when coadministered with other childhood
vaccines, the immunogenicity of
Infanrix hexa or that of the concomitantly administered
vaccine was generally not altered.
Hexavalent vaccines, including
Infanrix hexa, were protective against invasive Hib disease;
Infanrix hexa is also expected to be protective against
pertussis. Most solicited local and general symptoms with
Infanrix hexa were mild to moderate in intensity and the
vaccine was associated with few unsolicited adverse events. Available clinical data from more than 10 years' experience with the
vaccine suggest that
Infanrix hexa as primary and booster vaccination is a safe and useful option for providing protection against the common childhood diseases of
diphtheria,
tetanus,
poliomyelitis,
pertussis,
hepatitis B and invasive Hib disease.