Healthy, non-pregnant women (intended indication: prevention of severe RSV disease in infants by transfer of maternal antibodies following active single dose immunisation of pregnant women) MedDRA version: 17.1 Level: PT Classification code 10061603 Term: Respiratory syncytial virus infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 17.1 Level: PT Classification code 10038718 Term: Respiratory syncytial virus bronchiolitis System Organ Class: 10021881 - Infect
Conditions
Interventions
Product Name: 30 µg PreF plain
Product Code: 30 µg PreF plain
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: NA
Other descriptive name: PreF protein
Concentra
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 study 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 study vaccination, and has a negative pregnancy test on the day of study vaccination, and has agreed to continue adequate contraception up to 90 days post-vaccination 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 500 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. -Any medical condition that in the judgment of the investi-gator would make intramuscular injection unsafe. -Planned administration/ administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after study vaccination, with the exception of any licensed influenza vaccine which may be administered = 15 days before or after study vaccination. -Previous experimental vaccination against RSV. -History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines. -History of severe allergic reaction after a previous dose of any tetanus toxoid, diphtheria toxoid, or pertussis antigen-containing vaccine or to any component 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. -Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to study vaccination, or planned administration during 90days post-vaccination. Inhaled and topical steroids are allowed. -Administration of immunoglobulins and/ or any blood products within the 3 months prior to study vaccination, or planned administration during 90 days post-vaccination. -Any confirmed or suspected immunosuppressive or im-munodeficient condition, based on medical history and physical examination. -Family history of congenital or hereditary immunodefi-ciency. -History of or current autoimmune disease. -Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality. -Malignancy within previous 5 years or lymphoproliferative disorder. -Current alcohol and/or drug abuse. -Acute disease and/ or fever at the time of enrolment. -Hypersensitivity to latex. -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 in-terfere with study procedures or findings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the reactogenicity and the safety of a single intramuscular dose of the investigational RSV vaccines, in healthy, non-pregnant women, during the first 30 days after vaccination. To evaluate the functional antibody titres induced by a single intramuscular dose of the investigational RSV vac-cines, in healthy, non-pregnant women, 30 days after vaccination.;Secondary Objective: To evaluate the safety of a single intramuscular dose of the investigational RSV vaccines, in healthy, non-pregnant women, up to study end. To evaluate the persistence of the functional antibody titres induced by a single intramuscular dose of the in-vestigational RSV vaccines, in healthy, non-pregnant women, up to 90 days after vaccination. To evaluate the Palivizumab-competing antibody (PCA) concentrations induced by a single intramuscular dose of the investigational RSV vaccines, in healthy, non-pregnant women, up to 90 days after vaccination. ;Primary end point(s): Occurrence of AEs from vaccination up to Day 30: •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. Immunogenicity in terms of functional antibody titres against RSV, in all subjects, in all groups.;Timepoint(s) of evaluation of this end point: Solicited local and general AEs: during a 7-day follow-up period (from day 0 to day 6) after vaccination Unsolicited AEs: during a 30-day follow-up period (from day 0 to day 29) after vaccination. SAEs: from vaccination (Day 0) up to Day 30 Neutralising antibody titres against RSV-A: pre-vaccination (at Day 0) and post-vaccination (at Day 30). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Occurrence of any SAE, in all subjects, in all groups. Immunogenicity in terms of functional antibody titres against RSV, in all subjects, in all groups. Immunogenicity in terms of Palivizumab-competing antibody (PCA) concentrations, in all subjects, in all groups.;Timepoint(s) of evaluation of this end point: SAEs: from vaccination (Day 0) up to study end (Day 360). Neutralising antibody titres against RSV-A: post-vaccination (at Day 60 and Day 90). PCA concentrations: pre-vaccination (at Day 0) and post-vaccination (at Day 30, Day 60 and Day 90). | — |
Countries
Australia, Czech Republic, Germany, United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed