Diphtheria, Haemophilus Influenzae Type b (Hib), Hepatitis B, Pertussis, Poliomyelitis, Tetanus
Conditions
Keywords
Infants, combined vaccine, DTPa-HBV-IPV/Hib, DTPa-IPV/Hib, safety, Immunogenicity, HBV
Brief summary
This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administration of DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines administered at 3 and 5 months of age.
Interventions
BIOLOGICALDTPa-HBV-IPV/Hib (Infanrix-hexa™)
3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8
BIOLOGICALDTPa-IPV/Hib (Infanrix-IPV/Hib™)
3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8
BIOLOGICALHBV (Engerix™-B)
3 doses administered intramuscularly into the left thigh at study month 0, 2 and 8
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 between 12 and 16 weeks 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
* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine. * Administration of chronic immunosuppressants or immune-modifying drugs during the study period. * Administration of a vaccine not foreseen by the study protocol during the period starting from one month before each dose and ending one month after each dose. * Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib diseases. * History of/or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. * History of allergic disease or reaction 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. * Progressive neurological disorders. * Administration of immunoglobulins and/or any blood products since birth and during the study period. * Acute febrile illness at the time of planned vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with antibody titers equal to or greater than cut-off value. | One month after the 2nd dose of the primary vaccination course (month 3) |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity with respect to components of the study vaccines in terms of antibody titers | One month after the 2nd dose (Month 3), before and one month after the 3rd dose of the primary vaccination course (Months 8 and 9) |
| Immunogenicity with respect to components of the study vaccines in terms of number of subjects with a vaccine response | One month after the 3rd dose of the primary vaccination course (Month 9) |
| Occurrence of solicited local symptoms | Within 4 days after each vaccination and overall |
| Immunogenicity with respect to 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 (Months 8 and 9) |
| Occurrence of unsolicited symptoms | Within 30 days after each vaccination, and overall |
| Occurrence of serious AEs | Throughout the entire study (approximately 9 months per subject) up to and including 30 days post-vaccination |
| Occurrence of solicited general symptoms | Within 4 days after each vaccination and overall |
Outcome results
None listed