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

GlaxoSmithKline102 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

102

Conditions

Respiratory Syncytial Virus Infections

Interventions

RSV vaccine GSK3003891ABIOLOGICAL

Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.

BoostrixBIOLOGICAL

Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

Wilrijk, Belgium

Outcomes

Primary Outcomes

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.

Time frame: At Day 7

Number of Subjects With Abnormal Biochemical Laboratory Values.

Time frame: 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.

Time frame: At Day 7

Number of Subjects With Abnormal Haematological Laboratory Values.

Time frame: At Day 30

Number of Subjects With Abnormal Haematological Laboratory Values.

Data from ClinicalTrials.gov

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