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DTPa-HBV-IPV/Hib vaccine (Infanrix hexa)
Monique P Curran1, Karen L Goa
1Adis International Limited, Auckland, New Zealand. demail@adis.co.nz
Insights
The Infanrix hexa vaccine provides strong infant protection against six diseases. Booster doses at 18 months ensure sustained immunity, demonstrating good tolerability and effectiveness.
Area of Science:
- Pediatric Vaccinology
- Immunology
- Public Health
Background:
- Infant vaccination is crucial for preventing communicable diseases.
- The diphtheria-tetanus-acellular pertussis-hepatitis B recombinant (adsorbed)-inactivated poliomyelitis-adsorbed conjugated Haemophilus influenzae type b vaccine (DTPa-HBV-IPV/Hib) is a combination vaccine for primary immunization.
- Evaluating vaccine efficacy and safety in infants is essential for public health strategies.
Purpose of the Study:
- To assess the immunogenicity and tolerability of the DTPa-HBV-IPV/Hib vaccine in infants.
- To compare the immune response elicited by DTPa-HBV-IPV/Hib with alternative vaccination schedules.
- To evaluate the safety profile of DTPa-HBV-IPV/Hib, including coadministration with other vaccines.
Main Methods:
- Infants received primary vaccination with DTPa-HBV-IPV/Hib.
- Seroprotection levels against diphtheria, tetanus, poliovirus, pertussis antigens, hepatitis B, and H. influenzae type b were measured.
- Immune responses were compared to infants receiving different vaccine combinations.
- Adverse reactions were monitored following vaccination.
Main Results:
- The DTPa-HBV-IPV/Hib vaccine induced high seroprotection against all targeted antigens.
- 97% of infants achieved protective anti-PRP levels after the 18-month booster dose.
- The vaccine elicited an immune response comparable to separate pentavalent and monovalent vaccines.
- Coadministration with a pneumococcal conjugate vaccine was well-tolerated and effective.
- The vaccine was generally well-tolerated, with mostly mild to moderate systemic and local reactions.
Conclusions:
- The DTPa-HBV-IPV/Hib vaccine is effective in providing seroprotection against six serious childhood diseases.
- The vaccine demonstrates a favorable safety profile and is well-tolerated in infants.
- This combination vaccine offers a convenient and immunogenic option for primary infant immunization schedules.
Abstract:
Primary vaccination of infants with diphtheria-tetanus-acellular pertussis-hepatitis B recombinant (adsorbed)-inactivated poliomyelitis-adsorbed conjugated Haemophilus influenzae type b vaccine (DTPa-HBV-IPV/Hib; Infanrix hexa)-inactivated poliomyelitis-absorbed conjugated Haemophilus influenzae type b vaccine (DTPa-HBV-IPV/Hib) refers to Infanrix hexa trade mark.) provided high levels of seroprotection against diphtheria toxoid, tetanus toxoid, poliovirus 1, 2 and 3, pertussis antigens (pertussis toxoid, filamentous haemagglutinin and pertactin), hepatitis B virus surface antigen and H. influenzae polyribosyl-ribitol-phosphate (PRP) antigen. Most infants (97%) had anti-PRP levels >/=0.15 micro g/mL after a booster dose at 18 months. Primary vaccination with the DTPa-HBV-IPV/Hib vaccine produced a similar immune response to that with two different pentavalent plus monovalent vaccine combinations. Coadministration of DTPa-HBV-IPV/Hib vaccine and a heptavalent pneumonococcal conjugate vaccine resulted in a high level of seroprotection and was well tolerated. Primary or booster vaccination with DTPa- HBV-IPV/Hib vaccine was well tolerated. Commonly reported local adverse reactions included redness, pain and swelling. Systemic symptoms were usually mild to moderate, and included fussiness, fever, restlessness and sleepiness.