Primary immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases.
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who the investigator believes that their par-ent/guardian can and will comply with the requirements of the protocol should be enrolled in the study. A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. Born after a gestation period of 36 to 42 weeks inclusive. Healthy subjects as established by medical history before entering into the study. Written informed consent obtained from the parent or guardian of the subject. Are the trial subjects under 18? yes Number of subjects for this age range: 224 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Use of any investigational or non-registered product within 30 days preceding the first dose of study vaccine, or planned use during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs from birth until first primary vac-cination dose. For corticosteroids, this will mean predni-sone, or equivalent, more than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). Major congenital defects or serious chronic illness. Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Hib vaccination or disease. Any confirmed or suspected immunosuppressive or im-munodeficient condition, based on medical history. History of allergic disease or reactions likely to be exac-erbated by any component of the vaccines. The following condition is temporary or self limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met: Current febrile illness or axillary temperature of more than or equal to 37.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the immune response to the Hib component of GSK Biologicals’ combined DTPa-HBV-IPV/Hib preservative-free vaccine in terms of seroprotection rates one month after the three-dose primary vaccination course in “Aboriginal infants” and “Other Non-Aboriginal infants”.;Secondary Objective: To assess the immune response to the Hib component of the combined DTPa-HBV-IPV/Hib vaccine in terms of anti-polyribosyl-ribitol phosphate (PRP) geometric mean concentrations (GMCs) one month after the three-dose primary vaccination course. To assess the immune response to the hepatitis B com-ponent of the combined DTPa-HBV-IPV/Hib vaccine in terms of seroprotection rates and anti-HBs GMCs one month after the three-dose primary vaccination course. To assess the safety of the combined DTPa-HBV-IPV/Hib vaccine in terms of medically attended adverse events and serious adverse events (SAEs) during the three-dose primary vaccination course.;Primary end point(s): Anti-PRP antibody concentrations more than or equal to 0.15 µg/ml.;Timepoint(s) of evaluation of this end point: At Month 5. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Anti-PRP antibody concentration more than or equal to 1 µg/ml. Anti-HBs antibody concentration more than or equal to 10 mIU/ml and more than or equal to 100 mIU/ml. Anti-PRP and anti-HBs antibody concentrations. Occurrence of medically attended adverse events and serious adverse events.;Timepoint(s) of evaluation of this end point: For all immunogenecity endpoints: At Month 5. For occurrence of medically attended adverse events and serious adverse events: Throughout the study period (Month 0 to Month 5). | — |
Countries
Canada
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed