Safety and reactogenicity study of GlaxoSmithKline (GSK) Biologicals’ investigational respiratory syncytial virus (RSV) vaccine (GSK3003891A) in healthy women.
- Conditions
- Healthy volunteers (prevention of severe RSV disease in infants by transfer of maternal antibodies following active single dose immunisation of pregnant women).MedDRA version: 18.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 18.1Level: PTClassification code 10038718Term: Respiratory syncytial virus bronchiolitisSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 18.1Level: LLTClassification code 10035692Term: Pneumonia due to respiratory syncytial virusSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2015-005742-58-BE
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject prior to performing any study specific procedure.
• Non-pregnant female between, and including, 18 and 45 years of age at the time of vaccination.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Female subjects of non-childbearing potential may be enrolled in the study.
• 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 dur-ing the entire study period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
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 other than the study vaccine within 30 days prior to study vaccination, 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.
• Chronic administration of immunosuppressants or other immune-modifying drugs, as well as administration of long-acting immune-modifying drugs during the period starting 6 months prior to study vaccination, or planned administration during the study period. Inhaled and topical steroids are allowed.
• Administration of immunoglobulins and/or any blood products during the period starting 3 months before study vaccination or planned administration during the study period.
• Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the study vaccina-tion, with the exception of any licensed influenza vaccine which may be administered 15 days before or after study vaccination.
• Previous experimental vaccination against RSV.
• Family history of congenital or hereditary immunodefi-ciency.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of or current auto-immune disease
• Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality as de-termined by physical examination and/or Medical History
• Lymphoproliferative disorder or malignancy within previous 5 years.
• History of hypersensitivity after a previous dose of any tetanus, diphtheria, or pertussis vaccine or to any com-ponent of Boostrix.
• History of encephalopathy of unknown aetiology occurring within 7 days following a previous vaccination with pertussis-containing vaccine.
• History of any neurological disorders or seizures.
• History of transient thrombocytopenia or neurological complications following a previous vaccination against diphtheria and/or tetanus.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
• Hypersensitivity to latex.
• Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
• Current chronic alcohol consumption and/or drug abuse.
• Acute disease and/or fever at the time of enrolment.
• Body mass index (BMI) > 40 kg/m2.
• Pregnant or lactating female.
• Planned move to a location that will prohibit participating in the trial until study end.
• Any other condition that the investigator judges may interfere with study procedures.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method