An open, randomized, phase IIIa study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ 10-valent pneumococcal conjugate vaccine, when administered intramuscularly according to a 2-4-11 months vaccination schedule. - 10PN-PD-DIT-002
- Conditions
- A 2-4-11 month vaccination schedule of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, co-administered with DTPa combined vaccines in healthy infants between 8-16 weeks of age at the time of first vaccination.
- Registration Number
- EUCTR2005-003437-41-SE
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
All subjects must satisfy the following criteria at study entry:
•Subjects for whom 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).
•A male or female between, and including, 8 and 16 weeks (56-120 days) of age at the time of the first vaccination.
•Written informed consent obtained from the parent or guardian of the subject.
•Free of obvious health problems as established by medical history and clinical examination before entering into the study.
•Born after a 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
The following criteria should be checked at the time of study entry. If any apply at the time of study entry, the subject must not be included in the study:
•Use of any investigational or non-registered 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.
•Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the first dose of vaccine(s) and ending 30 days after the last dose, with exception of BCG vaccination which can be given after visit 4 and a minimum of 30 days before visit 5.
•Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae.
•History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, and/or invasive pneumococcal diseases.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
•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 oral/axillary/tympanic temperature <37.5°C / rectal temperature <38.0°C. Study entry should be delayed until the illness has improved.
•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).
•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.
•Major congenital defects or serious chronic illness.
•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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method