Please note the ANZCTR will be unattended from Friday 24 December 2021 for the holidays. The Registry will re-open on Monday 17 January 2022. Submissions and updates will not be processed during that time.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. We recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02360475




Registration number
NCT02360475
Ethics application status
Date submitted
29/01/2015
Date registered
10/02/2015
Date last updated
3/07/2018

Titles & IDs
Public title
Safety, Reactogenicity and Immunogenicity Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Women
Scientific title
An Observer-blind Study to Assess the Safety, Reactogenicity and Immunogenicity of Different Formulations of GSK Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Women
Secondary ID [1] 0 0
2014-002688-14
Secondary ID [2] 0 0
201510
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - RSV vaccine GSK3003895A (formulation 1)
Other interventions - RSV vaccine GSK3003898A (formulation 2)
Other interventions - RSV vaccine GSK3003899A (formulation 3)
Other interventions - Boostrix

Experimental: RSV vaccine formulation 1 Group - Subjects in this group will receive a single dose of formulation 1 of the RSV vaccine

Experimental: RSV vaccine formulation 2 Group - Subjects in this group will receive a single dose of formulation 2 of RSV vaccine

Experimental: RSV vaccine formulation 3 Group - Subjects in this group will receive a single dose of formulation 3 of RSV vaccine

Active Comparator: Boostrix Group - Subjects in this group will receive a single dose of Boostrix


Other interventions: RSV vaccine GSK3003895A (formulation 1)
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm

Other interventions: RSV vaccine GSK3003898A (formulation 2)
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm

Other interventions: RSV vaccine GSK3003899A (formulation 3)
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm

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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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 = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 100 millimeters (mm).
Timepoint [1] 0 0
During the 7-day (Days 0-6) post-vaccination period
Primary outcome [2] 0 0
Number of Subjects With Solicited General Symptoms - 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.
Timepoint [2] 0 0
During the 7-day (Days 0-6) post-vaccination period
Primary outcome [3] 0 0
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 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.
Timepoint [3] 0 0
During the 30-Day (Days 0-29) post-vaccination period
Primary outcome [4] 0 0
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.
Timepoint [4] 0 0
From vaccination at Day 0, up to Day 30 post-vaccination
Primary outcome [5] 0 0
Titres of RSV-A Neutralizing Antibodies - 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).
Timepoint [5] 0 0
At Day 0 pre-vaccination
Primary outcome [6] 0 0
Titres of RSV-A Neutralizing Antibodies - 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).
Timepoint [6] 0 0
At Day 30 post-vaccination
Secondary outcome [1] 0 0
Titres of RSV-A Neutralizing Antibodies - 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).
Timepoint [1] 0 0
At Day 60 post-vaccination
Secondary outcome [2] 0 0
Titres of RSV-A Neutralizing Antibodies - 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).
Timepoint [2] 0 0
At Day 90 post-vaccination
Secondary outcome [3] 0 0
Concentrations of Palivizumab Competing Antibodies (PCA) - 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).
Timepoint [3] 0 0
At Day 0 pre-vaccination
Secondary outcome [4] 0 0
Concentrations of PCA - 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).
Timepoint [4] 0 0
At Day 30 post-vaccination
Secondary outcome [5] 0 0
Concentrations of PCA - 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).
Timepoint [5] 0 0
At Day 60 post-vaccination
Secondary outcome [6] 0 0
Concentrations of PCA - 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).
Timepoint [6] 0 0
At Day 90 post-vaccination
Secondary outcome [7] 0 0
Number of Subjects With SAEs - SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Timepoint [7] 0 0
Up to study end at Day 360

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Czechia
State/province [8] 0 0
Hradec Kralove
Country [9] 0 0
Germany
State/province [9] 0 0
Bayern
Country [10] 0 0
Germany
State/province [10] 0 0
Sachsen
Country [11] 0 0
Germany
State/province [11] 0 0
Schleswig-Holstein

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02360475
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications