Primary vaccination course in children receiving the pneumococcal vaccine GSK 1024850A or Prevenar™ co-administered with Hiberix™.

• Conditions: Healthy volunteers (Three dose primary vaccination of healthy infants between 6 to 12 weeks of age at the time of the first vaccination against Streptococcus pneumoniae 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: EUCTR2015-001505-14-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: 503

Inclusion Criteria

• Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
• Male or female subjects between, and including 6-12 weeks (42 to 90 days) of age at the time of the first vac-cination.
• Written informed consent obtained from the parent(s) or 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 inclusive, with a birth weight of at least 2.5 kg.
Are the trial subjects under 18? yes
Number of subjects for this age range: 503
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.
• Planned administration/administration of a vaccine not allowed by the study protocol during the study period. Vaccines included in the Korean routine immunization schedule can be administered at least one week before or at least one month after the administration of the study vaccines. In addition, recommended live vaccines not in-cluded in the Korean routine immunization schedule can be given at least one month before or at least one month after the administration of the study vaccines.
• A family history of congenital or hereditary immunodeficiency.
• 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 immunoglobulins at birth).
• Previous vaccination against Streptococcus pneumoniae and/or Haemophilus influenzae type b.
• History of, or intercurrent Streptococcus pneumoniae and/or Haemophilus influenzae type b disease.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• History of any neurological disorders or seizures.
• Major congenital defects or serious chronic illness.
• Acute disease at the time of enrolment.

Study & Design

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