A phase IIIb randomised, open, controlled study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine when co-administered with DTPa-combined, MenC and Hib-MenC vaccines in children as a 3-dose primary immunization course during the first 6 months of age. - 10PN-PD-DIT-011

Conditions: Three dose primary vaccination of healthy infants between 6 to 16 weeks of age at the time of the first vaccination against Streptococcus pneumonia, Neisseria meningitidis and Haemophilus influenzae type b.

Registration Number: EUCTR2006-000558-30-DE

Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1440

Inclusion Criteria

All subjects must satisfy the following criteria at study entry:
•A male or female between, and including, 6-16 weeks (42 to 118 days) of age at the time of the first vaccination.
•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).
•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 (between 36 and 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

Exclusion Criteria

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
•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 (active and 6 months safety follow-up phases of the study).
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
•Planned administration / administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3.
•Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, meningococcal serogroup C and/or S. pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations (for example hepatitis B vaccination, BCG vaccination)
•History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, meningococcal serogroup C.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including diphtheria toxoid.
•History of seizures or neurological disease.
•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 diarrhea or mild upper respiratory infections with or without low-grade febrile illness, i.e oral/axillary/tympanic temperature < 37.5°C / rectal temperature < 38.0°C).
•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 active phase study.