Impact of GSK Biologicals’ 2189242A vaccine on nasopharyngeal carriage, safety and immunogenicity when co-administered with routine EPI vaccines in infants following safety assessment in children aged 2-4 yrs in The Gambia.

• Conditions: Healthy volunteers (for one-dose vaccination of healthy children between 2-4 years of age at the time of vaccination against Streptococcus pneumoniae (S. pneumoniae) and Haemophilus influenzae (H. influenzae) and three-dose vaccination of healthy infants between 8-10 weeks (56-76 days) of age at the time of the first vaccination, against S. pneumoniae and H. influenzae according to either a 2-3-4 months of age schedule or a 2-4-9 months of age schedule); MedDRA version: 18.0Level: LLTClassification code 10042196Term: Streptococcus pneumoniae secondary bacterial infection of acute bronchitisSystem Organ Class: 100000004862; 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 10018954Term: Haemophilus influenzae secondary bacterial infection of acute bronchitisSystem Organ Class: 100000004862; MedDRA version: 18.0Level: LLTClassification code 10042194Term: Streptococcus pneumoniae meningitisSystem Organ Class: 100000004862; MedDRA version: 18.0Level: LLTClassification code 10054642Term: Streptococcus pneumoniae septicemiaSystem Organ Class: 100000004862; MedDRA version: 18.0Level: LLTClassification code 10018953Term: Haemophilus influenzae meningitisSystem Organ Class: 100000004862; MedDRA version: 18.0Level: LLTClassification code 10018952Term: Haemophilus influenzae infectionSystem Organ Class: 100000004862; MedDRA version: 18.0Level: LLTClassification code 10058214Term: Septicaemia due to Haemophilus influenzae (H. influenzae)System Organ Class: 100000004862

• Registration Number: EUCTR2012-002727-15-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-22
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 1320

Inclusion Criteria

Inclusion criteria for subjects in Cohort 1 (children) and Cohort 2 (infants):
• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
• Male or female between, and including,
- 2 to 4 years of age at the time of the first vaccination for subjects in Cohort 1 (children).
- 8 to 10 weeks (56-76 days) of age at the time of the first vaccination for subjects in Cohort 2 (infants).
• Signed or thumb-printed informed consent obtained from the parents/LAR(s) of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Permanent residence in the study area and no intention of leaving during the study period.
Additional inclusion criteria for subjects in Cohort 1:
• Previously completed three-dose primary course of diphtheria-tetanus-pertussis (DTP) vaccination.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1320
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

Exclusion criteria for subjects in Cohort 1 (children) and Cohort 2 (infants):
• Child in care.
• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the exception of licensed flu vaccines or other vaccines recommended as part of a national campaign (e.g. Polio, Measles or Meningococcal Vaccines).
• 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
• Previous vaccination against S. pneumoniae.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Malnutrition
• A family history of congenital or hereditary immunodeficiency.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
• Major congenital defects or any chronic illness.
• History of any neurologic disorders or seizures.
• Acute disease and/or fever at the time of enrolment.
• Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
• Contraindications to any co-administered vaccine.
• Any medical condition that would contraindicate the initiation of routine immunization outside a clinical trial context.
Additional exclusion criteria for subjects in Cohort 2:
• Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b with the exception of vaccines where the first dose should be given within the first two weeks of life according to the national recommendations (for example Bacillus Calmette-Guérin [BCG] and hepatitis B vaccination).

Study & Design

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