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DTPa-HBV-IPV/Hib Vaccine (Infanrix hexa™)

A Review of its Use as Primary and Booster Vaccination

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Abstract

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 ≤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 article 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 titres. Moreover, antibodies against vaccine toxoids/antigens persisted for up to a mean of ≈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.

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    Sohita Dhillon

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Correspondence to Sohita Dhillon.

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Various sections of the manuscript reviewed by: S.L. Block, Kentucky Pediatric Research, Bardstown, Kentucky, USA; G. Gabutti, Department of Clinical and Experimental Medicine, University of Ferrara, Ferrara, Italy; M.E. Pichichero, Rochester General Hospital, Research Institute, Center for Infectious Diseases and Immunology, Rochester, New York, USA; R. Prymula, Department of Epidemiology, University of Defence, Hradec Kralove, Czech Republic.

Data Selection

Sources: Medical literature published in any language since 1980 on ‘DTPa-HBV-IPV/Hib vaccine’, identified using MEDLINE and EMBASE, supplemented by AdisBase (a proprietary database). Additional references were identified from the reference lists of published articles. Bibliographical information, including contributory unpublished data, was also requested from the company developing the drug.

Search strategy: MEDLINE, EMBASE and AdisBase search terms were ‘DTPa-HBV-IPV/Hib vaccine’ or ‘DTaP-IPV-HBV/Hib vaccine’ or ‘hib-DTaP-hepatitis B-poliovirus vaccine’. Searches were last updated 17 April 2010.

Selection: Immunogenicity and/or safety studies in healthy infants aged less than 3 years who received DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™). Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.

Index terms: Diphtheria, tetanus, pertussis, hepatitis, polio, Haemophilus influenzae type b, vaccine, immunogenicity, reactogenicity.

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Dhillon, S. DTPa-HBV-IPV/Hib Vaccine (Infanrix hexa™). Drugs 70, 1021–1058 (2010). https://doi.org/10.2165/11204830-000000000-00000

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