Healthy volunteers (Primary immunization of healthy infants at 2, 4 and 6 months of age against diphtheria, tetanus, pertussis and poliomyelitis diseases).
Conditions
Interventions
Trade Name: INFANRIX TETRA
Product Code: DTPa-IPV
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: -
Current Sponsor code: D
Other descriptive name: DIPHTHERIA TOXOID
Concentration u
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 (56-90 days) of age at the time of the first vaccination. •Written informed consent obtained from the parent or guardian of the subject. •Healthy subjects as established by medical history and clinical examination before entering into the study. •Born after a gestation period of 36 to 42 weeks inclusive. Are the trial subjects under 18? yes Number of subjects for this age range: 458 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 since birth. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) •Administration of any vaccine within 30 days (i.e. - 30 days to -1 day) before the first dose of the study vaccine. •Planned administration/ administration of a vaccine not foreseen by the study protocol during the study period (i.e. Day 0 to Month 7), with the exception of Bacille Calmette-Guérin (BCG) vaccine, hepatitis B vaccine, pneumococcal vaccine, flu vaccine and Hib vaccine. •Planned administration/ administration of a vaccine foreseen by the study protocol (i.e. BCG vaccine, hepatitis B vaccine, pneumococcal, flu vaccine and Hib vaccine) during the period 30 days before and one week after the study vaccine dose. •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). •Previous vaccination against diphtheria, tetanus, pertussis and/or poliovirus disease. •History of diphtheria, tetanus, pertussis and/or poliovirus diseases. •Known exposure to diphtheria, tetanus, pertussis and/or poliovirus before the study period. •Any anaemia/ thrombocytopenia or blood clot that leads to prohibition from intramuscular injection. •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). •A family history of congenital or hereditary immunodeficiency. •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). •Major congenital defects or serious chronic illness. •History of any neurologic disorders or seizures. •Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever.) All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Axillary temperature <37.5°C (99.5°F) / Rectal temperature <38°C (100.4°F). •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority of the DTPa-IPV vaccine to DTPa and IPV vaccines administered separately, in terms of antibody response against all vaccine antigens, one month after the three-dose primary vaccination course.;Secondary Objective: •To assess the immunogenicity of all the vaccine antigens one month after the three-dose primary vaccination course with the DTPa-IPV vaccine and with DTPa and IPV vaccines administered separately. •To assess the safety and reactogenicity of the study vaccines administered in both groups after each vaccine dose. ;Primary end point(s): Immunogenicity: •Anti-diphtheria antibody concentration greater than or equal to 0.1 IU/ml by ELISA. •Anti-tetanus antibody concentration greater than or equal to 0.1 IU/ml. •Anti-poliovirus type 1 titre greater than or equal to 8. •Anti- poliovirus type 2 titre greater than or equal to 8. •Anti- poliovirus type 3 titre greater than or equal to 8. •Anti-PT, anti-PRN and anti-FHA antibody concentrations. •Vaccine response to PT, PRN and FHA. ;Timepoint(s) of evaluation of this end point: One month after the three-dose primary vaccination course. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity: Geometric mean concentration or titre (GMC or GMT) of anti-bodies for all vaccine antigens. Occurrence of solicited local adverse events. Occurrence of solicited general adverse events. Occurrence of unsolicited local and general adverse events. Occurrence of serious adverse events (SAEs). ;Timepoint(s) of evaluation of this end point: Immunogenicity: Geometric mean concentration or titre (GMC or GMT) of anti-bodies for all vaccine antigens-One month after the three-dose primary vaccination course. Occurrence of solicited local adverse events-During the 4 day (Day 0 to Day 3) follow-up period after vaccination. Occurrence of solicited general adverse events-During the 4-day follow-up period after vaccination. Occurrence of unsolicited local and general adverse events-During the 31-day (Day 0 to Day 30) follow-up period after vaccination. Occurrence of serious adverse events (SAEs)-During the entire study period. | — |
Countries
Korea, Republic of
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed