EUCTR2009-012701-19-CZActive, not recruitingNot Applicable
A phase II, randomized, controlled, observer-blind study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ Streptococcus pneumoniae protein containing vaccine formulations when administered according to a 0-2-6 month schedule, in healthy children aged 12-23 months at the time of first vaccination. - SPNG-002
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- GlaxoSmithKline Biologicals
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
- •Male or female between, and including, 12 and 23 months of age at the time of the first vaccination.
- •Written 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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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 vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccinedose. For corticosteroids, this will mean prednisone = 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- •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).
- •Previous vaccination against S. pneumoniae since birth.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus (HIV) infection.
- •A family history of congenital or hereditary immunodeficiency.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures.
- •Acute disease and/or fever at the time of enrolment.
- •- Fever is defined as temperature = 37.5°C on oral, axillary or tympanic setting, or = 38.0°C on rectal setting.
- •- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
- •Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned use during the study period.
- •Child in care.
- •Please refer to the Glossary of Terms for the definition of a child in care.
Investigators
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