Primary vaccination course in healthy children receiving the pneu-mococcal vaccine GSK 1024850A co-administered with Tritanrix™-HepB/Hib at 6, 10 and 14 weeks of age.

• Conditions: Healthy volunteers (Three dose primary vaccination of healthy infants between 6 to 10 weeks of age at the time of the first vaccination against Streptococcus pneumoniae, diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b diseases.); MedDRA version: 18.0Level: LLTClassification code 10042197Term: Streptococcus pneumoniae septicaemiaSystem Organ Class: 100000004862; MedDRA version: 18.0Level: LLTClassification code 10042195Term: Streptococcus pneumoniae pneumoniaSystem Organ Class: 100000004862; MedDRA version: 18.0Level: LLTClassification code 10054642Term: Streptococcus pneumoniae septicemiaSystem Organ Class: 100000004862; MedDRA version: 18.0Level: LLTClassification code 10035648Term: Pneumococcal pneumonia [Streptococcus pneumoniae pneumonia]System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-004644-22-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-17
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
• Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
• Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
• Free of any known or suspected health problems (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: 360
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 vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
• 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).
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
• A family history of congenital or hereditary immunodefi-ciency.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis B immuno-globulins at birth).
• Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of hepatitis B vaccination at birth or at least 30 days before the subject’s first study visit).
• History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and Haemophilus influenzae type b disease.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• History of any neurological disorders or seizures.
• Major congenital defects or serious chronic illness.
• Acute disease at the time of enrolment.
• Babies for which birth weight is < 2 kilogram.

Study & Design

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