Acellular Pertussis, Diphtheria, Hepatitis B, Poliomyelitis, Tetanus
Conditions
Brief summary
The purpose of this study is to evaluate the immune response and reactogenicity of GSK Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine, administered concomitantly as a three-dose primary vaccination course.
Interventions
BIOLOGICALPediarix TM, Infanrix penta TM
The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.
BIOLOGICALHiberix TM
The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 8 Weeks
Healthy volunteers
Yes
Inclusion criteria
* A male or female infant between 6 and 8 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. * Born after a normal gestation period (between 36 and 42 weeks).
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 other immune-modifying drugs since birth or planned administration during the study. * Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after. * Previous vaccination against diphtheria, tetanus, pertussis, polio or Haemophilus influenzae type b. * History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, polio and/or Haemophilus influenzae type b. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection. * Major congenital defects * Serious chronic illness * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * Acute disease at the time of enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-PRP antibody titers | One month after the 3rd dose of the primary vaccination course |
| Anti-diphtheria toxoid and anti-tetanus toxoid antibody titers | One month after the 3rd dose of the primary vaccination course |
| Anti-HBs antibody titers | One month after the 3rd dose of the primary vaccination course |
| Anti-polio virus types 1, 2 and 3 antibody titers | One month after the 3rd dose of the primary vaccination course |
| Anti-PT, anti-FHA and anti-PRN antibody titers. | One month after the 3rd dose of the primary vaccination course |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of unsolicited adverse events | During the 30-day follow-up period after each dose |
| Occurrence of Serious Adverse Events | Over the course of the study |
| Occurrence of solicited adverse events | During the 4-day follow-up period after each dose |
Outcome results
None listed