Primary immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b diseases.
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •A male or female infant between, and including, 60 and 90 days of age at the time of the first study visit. •Born after a gestation period of 36 to 42 weeks, inclusive. •Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) 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. •Written informed consent obtained from the parent(s) or 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: 985 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. •Child in care. •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. 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 of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period with the exception of hepatitis B 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/or Hib disease or vaccination. •History of seizures or progressive neurological disease. •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). •Major congenital defects or serious chronic illness. The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met: •Current febrile illness or axillary temperature > 37.00°C or other moderate to severe illness within 24 hours of study vaccine administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the immunogenicity of GSK Biologicals’ DTPa-IPV/Hib vaccine administered at 2, 3 and 4 months of age (Group A) is non-inferior to that of the concomitant administration of GSK Biologicals’ DTPa/Hib and IPV vaccines at the same age (Control Group), in terms of immune response to all vaccine antigens, one month after the third vaccine dose.;Secondary Objective: •To assess the immunological response to the study vaccines in terms of seroprotection/seropositivity, GMCs or GMTs for all antigens and in terms of vaccine response for pertussis antigens, one month after the third vaccine dose. •To assess the safety and reactogenicity of the study vaccines in terms of solicited, unsolicited, local and general symptoms and serious adverse events. ;Primary end point(s): Immunogenicity to study vaccine antigens. -Anti-tetanus, anti-diphtheria, anti-PRP and anti-poliovirus type 1, 2 and 3 seroprotection status. -Vaccine response to the pertussis antigens. ;Timepoint(s) of evaluation of this end point: Month 3/4. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity to study vaccine antigens. -Anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, anti-PRN, anti-PRP, anti-poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3 antibody concentrations or titres. Occurrence of solicited local and general symptoms. Occurrence of unsolicited symptoms Occurrence of Serious Adverse Events (SAEs).;Timepoint(s) of evaluation of this end point: Immunogenicity to study vaccine antigens-Anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, anti-PRN, anti-PRP, anti-poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3 antibody concentrations or titres-Month 0/1 and Month 3/4.. Occurrence of solicited local and general symptoms-During the 4-day (Day 0–Day 3) follow-up period after booster vaccination. Occurrence of unsolicited symptoms-During the 31-day (Day 0–Day 30) follow up period after booster vaccination. Occurrence of Serious Adverse Events (SAEs)-From Month 0 to Month 4. | — |
Countries
China
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed