Primary immunization of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases.
Conditions
Interventions
Product Name: Diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis and H. influenzae type b vaccin
Product Code: DTPa-HBV-IPV/Hib
Pharmaceutical Form: Suspension for injection
INN or P
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study. -A male or female between, and including, 8 and 12 weeks of age at the time of the first vaccination. -Written informed consent obtained from the parents/guardians of the subject. -Healthy subjects as established by medical history and clinical examination before entering into the study. -Born after a normal gestation period of 36 to 42 weeks. Are the trial subjects under 18? yes Number of subjects for this age range: 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 (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. -Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth until first primary vaccination dose. (For corticosteroids, this will mean prednisone, or equivalent, >=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. -Administration/planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first dose and ending 30 days after the last dose, with the exception of the human rotavirus (HRV) vaccine. -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). -Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib vaccination or disease. -HBV vaccination at birth. -History of seizures or progressive neurological disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ->To demonstrate that immunogenicity of the DSSITGDPa-HBV-IPV/Hib vaccine (preservative-free formulation) in terms of antibody response to all vaccine antigens is non-inferior to DTPa-HBV-IPV/Hib vaccine (licensed formulation), 1 month after a 3-dose primary vaccination. Criteria for non-inferiority (1 month after the third dose): - For diphtheria (Vero-cell neutralization assay), tetanus, hepatitis B, poliovirus types 1, 2 and 3 and polyribosyl-ribitol phosphate (PRP): the upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference [DTPa-HBV-IPV/Hib (licensed formulation) minus DSSITGDPa-HBV-IPV/Hib (preservative-free formulation)] in the percentage of seroprotected subjects is =To demonstrate that immunogenicity of the DSSITGDPa-HBV-IPV/Hib (preservative-containing formulation) for all vaccine antigens is non-inferior to DTPa-HBV-IPV/Hib (licensed formulation), post-dose 3. This objective will be assessed without adjustment of the type 1 error. Hence, the probability to falsely conclude non-inferiority for this objective is 5% (instead of 2.5% usually required to control for this risk). Criteria for non-inferiority (post-dose 3): -For D (Vero-cell neutralization assay), T, HBsAg, poliovirus types 1, 2 and 3, and PRP: the UL of the standardized asymptotic 95% CI on the group difference [DTPa-HBV-IPV/Hib (licensed formulation) minus DSSITGDPa-HBV-IPV/Hib (preservative-containing formulation)] in the % of seroprotected subjects is =Seroprotection status -Anti-diphtheria antibody concentrations >= 0.016 IU/ml (based on Vero-cell neutralization assay). -Anti-tetanus toxoid antibody concentrations >= 0.1 IU/ml. -Anti-HBs antibody concentrations >= 10 mIU/ml. -Anti-poliovirus type 1 antibody titres >= 8. -Anti-poliovirus type 2 antibody titres >= 8. -Anti-poliovirus type 3 antibody titres >= 8. -Anti-PRP antibody concentrations >= 0.15 µg/ml. ->Anti-PT, anti-FHA and anti-PRN antibody concentrations | — |
Countries
Finland
Outcome results
None listed