Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A) in Healthy Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and reactogenicity of a single intramuscular dose of GSK Biologicals' investigational RSV vaccine, in healthy, non-pregnant women aged 18 to 45 years.

Official Title
-----------------
An Observer-blind Safety and Reactogenicity Study to Assess GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A) in Healthy Women

Conditions
-----------------
Respiratory Syncytial Virus Infections

Intervention / Treatment
-----------------
* Biological: RSV vaccine GSK3003891A
* Biological: Boostrix


Participation Criteria
=================
Eligibility 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 during the entire study period. 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 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. 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 auto-immune 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 hypersensitivity after a previous dose of any tetanus, diphtheria, or pertussis 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. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RSV group<br>Subjects in this group will receive a single dose of the RSV vaccine. | Biological: RSV vaccine GSK3003891A<br>* Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.<br>|
| Active Comparator: Boostrix group<br>Subjects in this group will receive a single dose of Boostrix. | Biological: Boostrix<br>* Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Abnormal Biochemical Laboratory Values. | Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CRE]. Biochemical value ranges assessed were below, within or above, as compared to baseline at Day 0. | At Day 7 | 
| Number of Subjects With Abnormal Biochemical Laboratory Values. | Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CRE]. Biochemical value ranges assessed were below, within or above, as compared to baseline at Day 0. | At Day 30 | 
| Number of Subjects With Abnormal Haematological Laboratory Values. | Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for EOS, Hgb and WBC. | At Day 7 | 
| Number of Subjects With Abnormal Haematological Laboratory Values. | Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for EOS, Hgb and WBC. | At Day 30 | 
| Number of Subjects With Abnormal Haematological Laboratory Values. | Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for LYM, NEU and PLT | At Day 7 | 
| Number of Subjects With Abnormal Haematological Laboratory Values. | Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for LYM, NEU and PLT. | At Day 30 | 
| Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading | Among biochemical parameters tested were ALT, AST and CRE, graded by FDA toxicity grading for biochemistry parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0. | From Day 7 up to Day 30 | 
| Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading | Among haematological parameters tested were EOS, decreased Hgb and LYM graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0. | From Day 7 up to Day 30 | 
| Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading | Among haematological parameters tested were NEU, PLT, decreased WBC and increased WBC/I, graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0. | From Day 7 up to Day 30 | 
| Number of Subjects With Haematology Change From Baseline by Maximum Grade | Assessed laboratory parameter changed from baseline was haemoglobin (Hgb). FDA grading for Hgb (change from baseline) was not applicable a baseline. | From Day 7 up to Day 30 | 
| Number of Subjects With Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimetres (mm) of injection site. All solicited local symptoms are considered as related to the vaccination. | During a 7-day follow-up period (from Day 0 to Day 6) after vaccination | 
| Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were fatigue, temperature (defined as oral temperature equal to or above [≥] 37.5 degrees Celsius [°C] for oral, axillary or tympanic route), gastrointestinal symptoms (gastro) including nausea, vomiting, diarrhoea and/or abdominal pain; and headache. Any = occurrence of the symptom regardless of intensity grade and relationship to the vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. | During a 7-day follow-up period (from Day 0 to Day 6) after vaccination | 
| Number of Subjects With Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | During a 30-day follow-up period (from Day 0 to Day 29) after vaccination | 
| Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | From vaccination (Day 0) up to study end (Day 30) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaccine, Safety, Reactogenicity, Respiratory syncytial virus (RSV)