Safety, Reactogenicity and Immunogenicity Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Women

Completed · Phase 2

Conditions studied: Respiratory Syncytial Virus Infections

In brief

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of different formulations of a single intramuscular dose of GSK Biologicals' investigational RSV vaccine, in healthy, non-pregnant women aged 18 to 45 years.

Key facts

Study ID

NCT02360475

Run by

GlaxoSmithKline

People needed

507

Starts

2015-03-20

Expected to finish

2016-06-21

Last updated by the study team

2018-07-03

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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 during the study period.

You may not qualify if…

• 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 investigator 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 the study period. 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 the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Family history of congenital or hereditary immunodeficiency.
• History of or current autoimmune disease.
• Acute or chronic, clinically significant pulmonary, cardiovascular, 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 interfere with study procedures or findings.

Where it is running

• GSK Investigational Site — Mesa, Arizona, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Lenexa, Kansas, United States
• GSK Investigational Site — Lexington, Kentucky, United States
• GSK Investigational Site — Milford, Massachusetts, United States
• GSK Investigational Site — Syracuse, New York, United States
• GSK Investigational Site — Austin, Texas, United States
• GSK Investigational Site — Melbourne, Victoria, Australia
• GSK Investigational Site — Hradec Králové, Czechia
• GSK Investigational Site — Würzburg, Bavaria, Germany
• GSK Investigational Site — Dippoldiswalde, Saxony, Germany
• GSK Investigational Site — Lübeck, Schleswig-Holstein, Germany

Full record on ClinicalTrials.gov

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