Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Non-typeable Haemophilus Influenzae (NTHI) Vaccine
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' NTHi candidate vaccine in adults, administered for the first time in humans.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
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Written informed consent obtained from the subject.
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A male or female between, and including, 18 and 40 years of age at the time of the first vaccination.
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Healthy subjects as established by medical history, physical examination and laboratory assessment before entering into the study.
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Female subjects of non-childbearing potential may be enrolled in the study.
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Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion criteria
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of 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 vaccine/product.
- Planned administration/administration of a vaccine/product not foreseen by the study protocol in the period starting 30 days before the first vaccine dose and ending 30 days after the last dose of vaccines.
- Previous vaccination with a vaccine containing NTHi antigens.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose, or equivalent. Topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccines or planned administration during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Laboratory evidence of clinically significant haematological (complete blood cell count [Red Blood Cells (RBC), White Blood Cells (WBC)], WBC differential count, platelets count and haemoglobin level) and biochemical (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], creatinine and lactate dehydrogenase [LDH]) abnormalities as per the opinion of the investigator based on the local laboratory normative data.
- Acute disease and/or fever at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- History of or current condition preventing intramuscular injection as bleeding or coagulation disorder.
- Malignancies within previous 5 years (excluding non-melanic skin cancer) and lymphoproliferative disorders.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- History of chronic alcohol consumption and/or drug abuse.
- Any other condition that the investigator judges may interfere with study findings.
Trial design
Primary purpose
Allocation
Interventional model
Masking
48 participants in 4 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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