Healthy volunteers (prevention of severe RSV disease in infants by transfer of maternal antibodies following active single dose immunisation of pregnant women). MedDRA version: 18.1 Level: PT Classification code 10061603 Term: Respiratory syncytial virus infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 18.1 Level: PT Classification code 10038718 Term: Respiratory syncytial virus bronchiolitis System Organ Class: 10021881 - Infections and infestations MedDRA
Conditions
Interventions
Product Name: 60 µg PreF
Product Code: 60 µg PreF
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: -
Other descriptive name: PreF protein
Concentration unit: µg
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the reactogenicity and safety of a single dose of the investigational RSV vaccine in healthy non-pregnant women during the study period.;Secondary Objective: Not applicable;Primary end point(s): • Occurrence of any haematological (haemoglobin level, leukocyte, neutrophil, lymphocyte, eosinophil and platelet count) and biochemical (ALT, AST and creatinine) laboratory abnormality in all subjects, in all groups. • Occurrence of adverse events (AEs) ?-Occurrence of each solicited local and general AE in all subjects, in all groups. ?- Occurrence of any unsolicited AE, in all subjects, in all groups. • Occurrence of any SAE in all subjects, in all groups. ;Timepoint(s) of evaluation of this end point: • Occurrence of any haematological and biochemical laboratory abnormality: Day 0, Day 7 and Day 30. • Occurence of solicited local and general AEs: during a 7-day follow-up period after vaccination (i.e. the day of vaccination and 6 subsequent days). • Occurence of unsolicited AEs: during a 30-day follow-up period after vaccination (i.e. the day of vaccination and 29 subsequent days). • Occurence of SAEs: from Day 0 up to study end (Day 30). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Belgium
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed