Primary immunization of healthy infants in the first year of life against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b (Hib) diseases.
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •A male or female between, and including, 42 and 69 days of age at the time of the first vaccination. •Born after a gestation period of 37 to 42 weeks inclusive. •Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). •Written informed consent obtained from the parent(s)/LAR(s) of the subject. •Healthy subjects as established by medical history and clinical examination before entering into the study. Are the trial subjects under 18? yes Number of subjects for this age range: 454 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: •Child in care. •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose, or planned use during the study period. •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone = 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. •Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, with the exception of hepatitis B and Bacillus Calmette-Guérin (BCG) vaccination; or planned administration during the study period, with the exception of hepatitis B and influenza vaccines, which will be allowed at least 7 days before or 30 days after the administration of the DTPa 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, poliomyelitis and Hib vaccination or disease. •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). •Family history of congenital or hereditary immunodeficiency. •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). •Major congenital defects or serious chronic illness. •History of any neurological disorders or seizures. •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. •Acute disease and/or fever at the time of enrolment. -Fever is defined as temperature = 37.5°C on oral, axillary or tympanic setting, or = 38.0°C on rectal setting. The preferred route for recording temperature in this study will be tympanic. -Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): -Anti-diphtheria, anti-tetanus, anti-poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3 and anti-PRP seroprotection status. -Anti-PT, anti-FHA and anti-PRN antibody concentrations. ;Timepoint(s) of evaluation of this end point: At Month 1. ;Main Objective: •To demonstrate that the immunogenicity of GSK Biologicals’ DTPa-IPV/Hib vaccine administered at 2, 4 and 6 months of age is non-inferior to that of the concomitant administration of GSK Biologicals’ DTPa-IPV and Hib vaccines, in terms of immune response to all vaccine antigens, one month after the third dose of the primary vaccination.;Secondary Objective: •To assess the immune response to the DTPa-IPV/Hib vaccine versus the DTPa-IPV and Hib vaccines administered separately, in terms of seroprotection/ seropositivity and antibody GMC/GMTs to all antigens and in terms of vaccine response to pertussis antigens one month after the third dose of primary vaccination. •To assess the safety and reactogenicity of the DTPa-IPV/Hib, DTPa-IPV and Hib vaccines, in terms of solicited and unsolicited, local and general symptoms. •To assess the safety of all study vaccines in terms of serious adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Anti-diphtheria, anti-tetanus, anti-poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3 and anti-PRP seroprotection status and antibody con-centrations or titres. -Anti-PT, anti-FHA and anti-PRN seropositivity status and antibody concentrations. -Vaccine response status to the pertussis antigens. -Occurrence of solicited local and general symptoms. -Occurrence of unsolicited symptoms. -Occurrence of Serious Adverse Events. ;Timepoint(s) of evaluation of this end point: -Anti-diphtheria, anti-tetanus, anti-poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3 and anti-PRP se-roprotection status and antibody concentrations or titres-At Month 0 and Month 6.5. -Anti-PT, anti-FHA and anti-PRN seropositivity status and antibody concentrations-At Month 0 and Month 6.5. -Vaccine response status to the pertussis antigens-At Month 6.5. Occurrence of solicited local and general symptoms-During the 4-day (Day 0–Day 3) follow-up period after each dose of the vaccine. Occurrence of unsolicited symptoms-During the 31-day (Day 0–Day 30) follow up period after each dose of the vaccine. Occurrence of Serious Adverse Events-From Month 0 up to Month 6.5. | — |
Countries
Korea, Republic of
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed