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

NCT ID: NCT02360475

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 507 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-20
• Study Completion Date: 2016-06-21

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.

Conditions

Respiratory Syncytial Virus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

RSV vaccine formulation 1 Group

Subjects in this group will receive a single dose of formulation 1 of the RSV vaccine

Group Type: EXPERIMENTAL

RSV vaccine GSK3003895A (formulation 1)

Intervention Type: BIOLOGICAL

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

RSV vaccine formulation 2 Group

Subjects in this group will receive a single dose of formulation 2 of RSV vaccine

Group Type: EXPERIMENTAL

RSV vaccine GSK3003898A (formulation 2)

Intervention Type: BIOLOGICAL

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

RSV vaccine formulation 3 Group

Subjects in this group will receive a single dose of formulation 3 of RSV vaccine

Group Type: EXPERIMENTAL

RSV vaccine GSK3003899A (formulation 3)

Intervention Type: BIOLOGICAL

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

Boostrix Group

Subjects in this group will receive a single dose of Boostrix

Group Type: ACTIVE_COMPARATOR

Boostrix

Intervention Type: BIOLOGICAL

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

Interventions

RSV vaccine GSK3003895A (formulation 1)

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

Intervention Type: BIOLOGICAL

RSV vaccine GSK3003898A (formulation 2)

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

Intervention Type: BIOLOGICAL

RSV vaccine GSK3003899A (formulation 3)

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

Intervention Type: BIOLOGICAL

Boostrix

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

Intervention Type: BIOLOGICAL

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 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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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

Countries

United States; Australia; Czechia; Germany

References

Steff AM, Cadieux-Dion C, de Lannoy G, Prato MK, Czeszak X, Andre B, Ingels DC, Louckx M, Dewe W, Picciolato M, Maleux K, Fissette L, Dieussaert I. Hamster neogenin, a host-cell protein contained in a respiratory syncytial virus candidate vaccine, induces antibody responses in rabbits but not in clinical trial participants. Hum Vaccin Immunother. 2020 Jun 2;16(6):1327-1337. doi: 10.1080/21645515.2019.1693749. Epub 2020 Jan 17.

Reference Type: DERIVED

PMID: 31951765 (View on PubMed)

Beran J, Lickliter JD, Schwarz TF, Johnson C, Chu L, Domachowske JB, Van Damme P, Withanage K, Fissette LA, David MP, Maleux K, Schmidt AC, Picciolato M, Dieussaert I. Safety and Immunogenicity of 3 Formulations of an Investigational Respiratory Syncytial Virus Vaccine in Nonpregnant Women: Results From 2 Phase 2 Trials. J Infect Dis. 2018 Apr 23;217(10):1616-1625. doi: 10.1093/infdis/jiy065.

Reference Type: DERIVED

PMID: 29401325 (View on PubMed)

Related Links

https://clinicalstudydatarequest.com

IPD for this study will be made available via the Clinical Study Data Request site.

Other Identifiers

2014-002688-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

201510

Identifier Type: -

Identifier Source: org_study_id