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The Immunological Response of Thai Infants to Haemophilus influenzae Type B Polysaccharide-Tetanus Conjugate Vaccine Co-administered in the Same Syringe with Locally Produced Diphtheria-Tetanus-Pertussis Vaccine

Angkool Kerdpanich MD*, Yanee Hutagalung MD**, Veerachai Watanaveeradej MD*, Hans L Bock MD**, Mark Steinhoff MD***

Affiliation : * Infectious Diseases Unit, Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand ** GlaxoSmithKline Biologicals, Rixensart, Belgium *** Johns Hopkins University, Baltimore, USA

Objective : Comparing the immunogenicity and reactogenicity of three vaccine combinations. These were GlaxoSmithKline Biologicals’ (GSK) Haemophilus influenzae type b vaccine (Hib-TT; Hiberix™) administered with the local Government Pharmaceutical Organization’s (GPO) diphtheria-tetanus-pertussis whole cell (DTPw) vaccine, Hib-TT mixed with GPO’s DTPw vaccine, or Hib -TT mixed with GSKs’ DTPw vaccine (Tritanrix™.
Materials and Methods : An open, randomized, controlled, single center study of three hundred and sixty infants. They were randomized into three groups to receive either Hib-TT; Hiberix™ mix with GPOs’ DTPw vaccine (group 1), Hib-TT mixed with GPO’s DTPw vaccine (group 2), or Hib -TT mixed with GSKs’ DTPw vaccine (Tritanrix™; group 3) at two, four and six months of age. Result: One month after the third dose, all subjects had antibodies level against Hib polyribosylribitol phos- phate (PRP) > 0.15 mg/ml. All subjects except two (in group 2) had anti-PRP levels > 1.0 mg/ml. The geometric mean concentrations were similar in all three groups. Over 96% of the subjects in all three groups demon- strated an immunological response to diphtheria, tetanus, and pertussis antigens. There was no difference among the three groups in terms of severe local reaction and fever.
Conclusion : The present study showed that the combined vaccines produced an effective antibody response with no increase in reactogenicity compared to separately administrated vaccines.

Keywords : Combined vaccine, Haemophilus influenzae, Immunogenicity, DTPw


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MEDICAL ASSOCIATION OF THAILAND
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