on-inferiority of a commercial lot of the pneumococcal vaccine GSK1024850A compared to a clinical lot.

• Conditions: Healthy volunteers (Three-dose primary vaccination against Streptococcus pneumoniae, diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b diseases, either a two-dose or three-dose primary vaccination against hepatitis B disease, and a two-dose primary vaccination against rotavirus disease in healthy infants between 6 and 12 weeks of age at the time of first vaccination); 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: EUCTR2014-000101-12-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-11
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 466

Inclusion Criteria

• Male or female subjects between, and including 6-12 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 re-quirements of the protocol.
• Written informed consent obtained from the parent(s)/guardian(s) 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: 466
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 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.
• 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, poliomyelitis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of vaccines where the first dose can be given within the first two weeks of life).
• Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 7 days after Dose 1 and Dose 2 and 30 days after Dose 3.
• History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, H. influenzae type b and rotavirus disease.
• History of allergic disease or reactions likely to be exac-erbated 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.
• Gastroenteritis within 7 days preceding the study vaccine administration.
• Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception or other medical condition determined to be serious by the investigator.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the immunogenicity of the commercial lot to the phase III clinical lot of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (10Pn-PD-DiT), one month following a 3-dose primary vaccination course. ;Secondary Objective: • To assess the safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (clinical and commercial lots) and of GSK Biologicals’ DTPa-combined and HRV vaccines.<br>• To evaluate the immunogenicity of GSK Biologicals’ DTPa-combined vaccines, one month following a 3-dose primary vaccination course.<br>• To evaluate the immunogenicity of GSK Biologicals’ HRV vaccine, three months following a 2-dose primary vac-cination course.;Primary end point(s): Concentrations of antibodies against vaccine components of the investigational pneumococcal conjugate vaccine;Timepoint(s) of evaluation of this end point: One month after primary immunization