An open, phase IIIb, randomized, multicentric clinical trial to compare the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ DTPa-IPV vaccine versus co-administration of GSK Biologicals’ DTPa vaccine and Sanofi-Pasteurs’ IPV vaccine at different injection sites, to healthy children at 2, 4 and 6 months of age.

• Conditions: Healthy volunteers (Primary immunization of healthy infants at 2, 4 and 6 months of age against diphtheria, tetanus, pertussis and poliomyelitis diseases).; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-001508-71-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-10
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 450

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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified