A study to rank different dosages of antigen of GlaxoSmithKline (GSK) Biologicals’ investigational Respiratory Syncytial Virus (RSV) vaccine (GSK3003891A), based on their immune response and safety, when administered to healthy adult women
Trial overview
Number of subjects with any Grade 2 and Grade 3 general Adverse Events (AEs) - solicited and unsolicited
Timeframe: During the 7-day (Days 0-6) post-vaccination period
Number of subjects with Grade 2 and Grade 3 fever
Timeframe: During the 7-day (Days 0-6) post-vaccination period
Number of subjects with related serious adverse events (SAEs)
Timeframe: During the 7-day (Days 0-6) post-vaccination period
Neutralizing antibody titers against RSV-A subtype
Timeframe: At Day 0
Neutralizing antibody titers against RSV-A subtype
Timeframe: At Day 30
Palivizumab competing antibody (PCA) concentrations
Timeframe: At Day 0
Pavilizumab competing antibody (PCA) concentrations
Timeframe: At Day 30
Number of subjects with any, Grade 2, Grade 3 and medically attended solicited local AEs
Timeframe: During the 7-day (Days 0-6) post-vaccination period
Number of subjects with any, Grade 2, Grade 3, related and medically attended solicited general AEs
Timeframe: During the 7-day (Days 0-6) post-vaccination period
Number of subjects with any unsolicited AEs
Timeframe: During the 30-day (Days 0-29) post-vaccination period
Number of subjects with any SAEs
Timeframe: From Day 0 up to study end, at Day 360
Number of subjects with any biochemical and hematological laboratory abnormalities
Timeframe: At Day 7
Number of subjects with any biochemical and hematological laboratory abnormalities
Timeframe: At Day 30
Number of subjects with any biochemical and hematological laboratory abnormalities
Timeframe: At Day 60
Number of subjects with any biochemical and hematological laboratory abnormalities
Timeframe: At Day 90
Number of subjects with any biochemical and hematological laboratory abnormalities, by maximum grading
Timeframe: From Day 7 up to Day 90
Neutralizing antibody titers against RSV-A subtype
Timeframe: At Day 60 and Day 90
Neutralizing antibody titers against RSV-B subtype
Timeframe: At Day 0, Day 30, Day 60 and Day 90
Palivizumab competing antibody (PCA) concentrations
Timeframe: At Day 60 and Day 90
Antibody concentrations against neogenin (NEO) residual host cell protein
Timeframe: At Day 0 and Day 30
Number of subjects with any medically attended (MA) respiratory tract infections (RTIs) associated with RSV
Timeframe: From Day 0 up to study end, at Day 360
- 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 performance of any study specific procedure.
- Use of any investigational or non-registered product other than the study vaccines within 30 days prior to study vaccination, or planned use during the study period.
- Concurrently participating in the active phase of 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.
- Written informed consent obtained from the subject prior to performance of 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 after vaccination.
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Non-childbearing potential is defined as pre-menarche, hysterectomy, ovariectomy or post-menopause.
- Concurrently participating in the active phase of 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, within 6 months prior to study vaccination, or planned administration until 90 days post-vaccination. For corticosteroids, this will mean prednisone ≥ 10 mg/day, or equivalent. Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products during the period starting 3 months before the study vaccination, or planned administration until 90 days post-vaccination.
- 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 neurological disorders or seizures.
- Family history of congenital or hereditary immunodeficiency.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of or current autoimmune disease
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality as determined by physical examination and/or Medical History.
- Lymphoproliferative disorder or malignancy within previous 5 years.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
- Hypersensitivity to latex.
- Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- Current alcohol and/or drug abuse.
- Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥37.5°C for oral, axillary or tympanic route, or ≥ 38.0°C for rectal route.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- 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 conclusion.
- Any other condition that the investigator judges may interfere with study procedures or findings.
Use of any investigational or non-registered product other than the study vaccines within 30 days prior to study vaccination, or planned use during the study period.
For subjects with acute disease and/or fever at the time of enrolment, Visit 1/Day 0 will be rescheduled within the allowed recruitment period.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.