Haemophilus influenzae type b vaccine has been approved in the European Union and in the Other Countries

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

The summaries are in PDF format. If you do not have Adobe® Acrobat® Reader™ installed, you can download it for free.


Haemophilus influenzae type b vaccine studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
104124 (Hib-095) IV An open, randomised post-marketing clinical trial to assess the safety and reactogenicity of GlaxoSmithKline Biologicals’ Haemophilus influenzae type b (Hib) tetanus conjugate vaccine (Hiberix™) co-administered with Chinese local DTPw vaccine when compared to Chinese local DTPw vaccine administered alone, in healthy infants at 3, 4 and 5 months of age
208108-083 (Hib-083) IV A phase IV, open, multicentric, post-marketing surveillance study to monitor the safety and reactogenicity of GlaxoSmithKline Biologicals’ Haemophilus influenzae type b vaccine (Hiberix™) in Korean subjects administered according to the Prescribing Information.
347414/036 III A phase-III, open, controlled study to assess the safety and immunogenicity of four different formulations of GlaxoSmithKline Biologicals’ (GSK Biologicals) investigational vaccination regimen when administered as a booster to healthy infants, 12 to 16 months old, previously vaccinated in infancy in a primary study.
101477 II A phase II, open, randomised clinical study to assess the immunogenicity and reactogenicity of a booster dose of an investigational vaccination regimen at 15-18 months of age in infants primed in the primary vaccination study.
208108/059 (Hib-059) II A post-marketing surveillance study of GlaxoSmithKline Biologicals’ Haemophilus influenzae type b (Hib) tetanus conjugate vaccine in 3,000 Filipino subjects.
208108/087 (Hib-087) II Phase II open randomized primary vaccination study to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals (GSK) Haemophilus influenzae type b (Hib) conjugate vaccine administered either mixed or in two separated injections with commercially available DTPw vaccine (Government Pharmaceutical Organization: GPO) as compared to GSK Biologicals’ Hib administered mixed with GSK Biologicals’ DTPw vaccine in healthy infants, aged 2, 4 and 6 months DTPw I: commercially available diphtheria, tetanus, whole cell pertussis vaccine;
208108/091 (Hib-091) and 208108/092 (Hib-092) II A phase II, double-blind, randomized study to compare the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB/Hib2.5 to GSK Biologicals’ Tritanrix™-HepB/Hiberix™ when administered as a three-dose primary vaccination course to healthy infants at 6, 10 and 14 weeks of age. A dose of unconjugated Hib vaccine (plain PRP booster) will be administered at the age of 10 months to 50% of the subjects. Tritanrix™-HepB/Hib2.5: combined diphtheria, tetanus, whole cell pertussis, hepatitis B vaccine with low thiomersal content and Haemophilus influenzae type b conjugate vaccine containing 2.5 µg PRP (DTPw-HBV/ Hib2.5). Tritanrix™-HepB: combined diphtheria, tetanus, whole cell pertussis and hepatitis B vaccine (DTPw-HBV). Hiberix™:: Haemophilus influenzae type b conjugate vaccine (Hib)
347414/029 II A multinational, randomised, controlled, open, phase II clinical study to evaluate the safety and immunogenicity of GSK Biologicals’ investigational vaccination regimen administered as a booster dose to healthy children 12 to 15 months old, previously vaccinated in infancy with the investigational vaccination regimen in a primary study.
371594/006 II A phase II, open, randomized study to assess the immune memory induced by a primary vaccination course of an investigational vaccination regimen and the immunogenicity and reactogenicity of a fourth dose of an investigational vaccination regimen, to healthy toddlers primed in study 371594/004.