Hepatitis B, Diphtheria, Haemophilus Influenzae Type b (Hib), Poliomyelitis, Pertussis, Tetanus
Conditions
Keywords
combination vaccine, DTPa-HBV-IPV, Hib
Brief summary
This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at 3, 5 and 11 (or 12) months of age.
Interventions
BIOLOGICALDTPa-HBV-IPV/Hib (Infanrix hexa™)
Three doses administered intramuscularly
BIOLOGICALDTPa-HBV-IPV (Infanrix penta™)
Three doses administered intramuscularly
BIOLOGICALHib (Hiberix™)
Three doses administered intramuscularly
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Weeks to 16 Weeks
Healthy volunteers
Yes
Inclusion criteria
* A male or female 3 months of age at the time of the first vaccination. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Written informed consent obtained from the parents or guardians of the subject after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.
Exclusion criteria
The following criteria should be checked at the time of study entry. If any apply at the time of study entry, the subject must not be included in the study: * Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Administration of chronic immunosuppressants or other immune-modifying drugs within three months before vaccination. * Administration of a vaccine not foreseen by the study within 30 days before each dose of the study vaccines and ending 30 days after. * Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease. * History of /or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease or infection. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including allergic reactions to neomycin and polymyxin B. * Major congenital defects or serious chronic illness. * History of seizures or of any neurological disease at study entry. * Administration of immunoglobulins and/or any blood products since birth, or planned administration during the study period. * Acute disease at time of enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off value | One month after the 2nd dose of the primary vaccination course ( Month 3) |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity with respect to the components of the study vaccines in terms of number of seropositive subjects | One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9) |
| Immunogenicity with respect to the components of the study vaccines in terms of antibody titres | One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9) |
| Immunogenicity with respect to the components of the study vaccines in terms of vaccine response | One month after the 3rd dose ( Month 9), and one month after the 2nd dose of the primary vaccination course ( Month3) |
| Immunogenicity with respect to the components of the study vaccines in terms of number of seroprotected subjects | One month after the 2nd dose ( Month 3), before and one month after the 3rd dose of the primary vaccination course ( Month 8 and 9) |
| Occurrence of solicited general symptoms | Within 4 days after each vaccination and overall |
| Occurrence of unsolicited symptoms | Within 30 days after each vaccination and overall |
| Occurrence of serious adverse events | Throughout the entire study up to and including 30 days post-vaccination ( Month 0 to Month 9) |
| Occurrence of solicited local symptoms | Within 4 days after each vaccination and overall |
Outcome results
None listed