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

Phase 2

Completed

• Conditions: Respiratory Syncytial Virus Infections
• Interventions: Biological: RSV vaccine GSK3003898A (formulation 2); Biological: RSV vaccine GSK3003895A (formulation 1); Biological: RSV vaccine GSK3003899A (formulation 3); Biological: Boostrix

• Registration Number: NCT02360475
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-29
• Study First Submitted QC: 2015-02-05
• Study First Posted: 2015-02-10
• Study Start: 2015-03-20
• Primary Completion: 2015-07-02
• Study Completion: 2016-06-21
• Results First Submitted: 2016-11-29
• Results First Submitted QC: 2017-07-14
• Results First Posted: 2017-08-16
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-31
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 507

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 during the study period.

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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 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RSV vaccine formulation 2 Group	RSV vaccine GSK3003898A (formulation 2)	Subjects in this group will receive a single dose of formulation 2 of RSV vaccine
RSV vaccine formulation 1 Group	RSV vaccine GSK3003895A (formulation 1)	Subjects in this group will receive a single dose of formulation 1 of the RSV vaccine
RSV vaccine formulation 3 Group	RSV vaccine GSK3003899A (formulation 3)	Subjects in this group will receive a single dose of formulation 3 of RSV vaccine
Boostrix Group	Boostrix	Subjects in this group will receive a single dose of Boostrix

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Unsolicited Adverse Events (AEs)	During the 30-Day (Days 0-29) post-vaccination period	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 outside 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.
Number of Subjects With Solicited Local Symptoms	During the 7-day (Days 0-6) post-vaccination period	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 100 millimeters (mm).
Number of Subjects With Solicited General Symptoms	During the 7-day (Days 0-6) post-vaccination period	Assessed solicited general symptoms (symp.) were headache, fever \[defined as oral temperature (temp.) equal to or above 37.5 degrees Celsius (°C)\], fatigue, gastrointestinal (Gastro.) symptoms \[nausea, vomiting, diarrhoea and/or abdominal pain\]. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 (G3) symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Number of Subjects With Serious Adverse Events (SAEs)	From vaccination at Day 0, up to Day 30 post-vaccination	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.
Titres of RSV-A Neutralizing Antibodies	At Day 30 post-vaccination	RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60).

Secondary Outcome Measures

Name	Time	Method
Titres of RSV-A Neutralizing Antibodies	At Day 90 post-vaccination	RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs), were defined as any titre greater than or equal to (≥) the cut-off 8 serum dilution inducing 60 % inhibition in plaque forming units (ED60).
Concentrations of PCA	At Day 90 post-vaccination	PCA concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).
Number of Subjects With SAEs	Up to study end at Day 360	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Concentrations of Palivizumab Competing Antibodies (PCA)	At Day 0 pre-vaccination	Palivizumab competing antibody concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Luebeck, Schleswig-Holstein, Germany