Primary vaccination course in children receiving the pneumococcal vaccine GSK 1024850A, Infanrix hexa and Rotarix
- Conditions
- Healthy volunteers (Three dose primary vaccination against Streptococcus pneumoniae, diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b diseases and a two dose primary vaccination against rotavirus in healthy infants between 6 to 8 weeks of age at the time of the first vaccination.)MedDRA version: 18.0Level: LLTClassification code 10042197Term: Streptococcus pneumoniae septicaemiaSystem Organ Class: 100000004862MedDRA version: 18.0Level: LLTClassification code 10042195Term: Streptococcus pneumoniae pneumoniaSystem Organ Class: 100000004862MedDRA version: 18.0Level: LLTClassification code 10054642Term: Streptococcus pneumoniae septicemiaSystem Organ Class: 100000004862MedDRA version: 18.0Level: LLTClassification code 10035648Term: Pneumococcal pneumonia [Streptococcus pneumoniae pneumonia]System Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2015-001511-12-Outside-EU/EEA
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 230
• Male or female subjects between, and including 6-8 weeks (42-62 days) 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 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 230
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
• 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.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month (30 days) before each dose of vaccines and ending 7 days after dose 1 and dose 2 and one month after dose 3.
• 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 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.
• Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, rotavirus and/or Streptococcus pneumoniae (with the exception of vaccines where the first dose may be given within the first two weeks of life according to the national recommendations).
• History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B and Haemophilus influenzae type b disease.
• 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.
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the immunogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine in Taiwan, one month post dose 3, when co-administered with GSK Biologicals’ Infanrix hexa and GSK Biologicals’ Rotarix vaccines;Primary end point(s): • Antibody concentrations to pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F<br>• Antibody concentrations to protein D;Timepoint(s) of evaluation of this end point: One month after the administration of the 3rd vaccine dose of 10Pn vaccine;Secondary Objective: • To assess the safety and reactogenicity of GSK Biologicals' 10-valent pneumococcal conjugate vaccine in Taiwan, when co-administered with GSK Biologicals' Infanrix hexa and GSK Biologicals' Rotarix vaccines.<br>• To assess the immunogenicity of GSK Biologicals' Infanrix hexa and Rotarix vaccines, when co-administered with GSK Biologicals' 10-valent pneumococcal conjugate vaccine
- Secondary Outcome Measures
Name Time Method