Respiratory Syncytial Virus InfectionsPhase 2NCT02360475

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

A Phase 2 study testing RSV vaccine GSK3003895A (formulation 1), RSV vaccine GSK3003898A (formulation 2) and RSV vaccine GSK3003899A (formulation 3) in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 12 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Respiratory Syncytial Virus Infections
What is being tested?: RSV vaccine GSK3003895A (formulation 1), RSV vaccine GSK3003898A (formulation 2) and RSV vaccine GSK3003899A (formulation 3)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 507 participants
Where: 12 sitesin 4 countries
Study dates: 20 Mar 2015to 21 Jun 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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:

Show all 9Show fewer

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.

Who cannot join

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.

Show all 23Show fewer

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.

Trial locations and contacts

12 sites in 4 countries.

Country

City, postcode or hospital

12 sites in 4 countries

United States7 sites

GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Lenexa, Kansas, 66219
GSK Investigational Site
Lexington, Kentucky, 40509
GSK Investigational Site
Mesa, Arizona, 85213
GSK Investigational Site
Milford, Massachusetts, 01757
GSK Investigational Site
San Diego, California, 92108
GSK Investigational Site
Syracuse, New York, 13210

Other trials in United States

Germany3 sites

GSK Investigational Site
Dippoldiswalde, Saxony, 01744
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23554
GSK Investigational Site
Würzburg, Bavaria, 97070

Other trials in Germany

Australia1 site

GSK Investigational Site
Melbourne, Victoria, 3004

Other trials in Australia

Czechia1 site

GSK Investigational Site
Hradec Králové

Other trials in Czechia

About this study

Official 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

Conditions: Respiratory Syncytial Virus Infections
Being tested: RSV vaccine GSK3003895A (formulation 1), RSV vaccine GSK3003898A (formulation 2), RSV vaccine GSK3003899A (formulation 3), Boostrix
Keywords: Vaccine, Immunogenicity, Safety, Respiratory syncytial virus (RSV), Reactogenicity
Medical subject headings: Respiratory Syncytial Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RSV vaccine GSK3003895A (formulation 1)Biological
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
RSV vaccine GSK3003898A (formulation 2)Biological
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
RSV vaccine GSK3003899A (formulation 3)Biological
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

Study groups in NCT02360475
Study group	Role	What they receive
RSV vaccine formulation 1 Group	Experimental	Subjects in this group will receive a single dose of formulation 1 of the RSV vaccine Receives: Biological: RSV vaccine GSK3003895A (formulation 1)
RSV vaccine formulation 2 Group	Experimental	Subjects in this group will receive a single dose of formulation 2 of RSV vaccine Receives: Biological: RSV vaccine GSK3003898A (formulation 2)
RSV vaccine formulation 3 Group	Experimental	Subjects in this group will receive a single dose of formulation 3 of RSV vaccine Receives: Biological: RSV vaccine GSK3003899A (formulation 3)
Boostrix Group	Active comparator	Subjects in this group will receive a single dose of Boostrix Receives: Biological: Boostrix

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: During the 7-day (Days 0-6) post-vaccination period
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.
Measured: During the 7-day (Days 0-6) post-vaccination period
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.
Measured: During the 30-Day (Days 0-29) post-vaccination period
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.
Measured: From vaccination at Day 0, up to Day 30 post-vaccination
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).
Measured: At Day 0 pre-vaccination
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).
Measured: At Day 30 post-vaccination

Secondary outcomes (7)

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).
Measured: At Day 60 post-vaccination
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).
Measured: At Day 90 post-vaccination
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).
Measured: At Day 0 pre-vaccination
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).
Measured: At Day 30 post-vaccination
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).
Measured: At Day 60 post-vaccination
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).
Measured: At Day 90 post-vaccination
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.
Measured: Up to study end at Day 360

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Mar 201521 Jun 2016

First posted10 Feb 2015 (estimated)
Study start20 Mar 2015
Primary completion2 Jul 2015
Study completion21 Jun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 507 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02360475
Sponsor's protocol ID: 201510
Other IDs: 2014-002688-14, 2014
Status last verified: May 2018
First submitted: 29 Jan 2015
Last updated: 3 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

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.
PubMed 31951765
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.
PubMed 29401325

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 3
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
Respiratory Syncytial Virus Infections
Active, not recruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Respiratory Syncytial Virus (RSV), Infectious Disease
RecruitingPhase 2
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Respiratory Syncytial Virus (RSV)
RecruitingObservational study
TARSILA Real-World Evidence Study
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All Respiratory Syncytial Virus Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT02360475
Acronym / sponsor ID: 201510
Conditions: Respiratory Syncytial Virus Infections
Keywords: Vaccine, Immunogenicity, Safety, Respiratory syncytial virus (RSV), Reactogenicity
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 507 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 20 Mar 2015 (actual)
Primary completion: 2 Jul 2015 (actual)
Study completion: 21 Jun 2016 (actual)
First posted: 10 Feb 2015 (estimated)
Results: Posted 16 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
RSV vaccine formulation 1 Group	Experimental	Biological: RSV vaccine GSK3003895A (formulation 1)Subjects in this group will receive a single dose of formulation 1 of the RSV vaccine
RSV vaccine formulation 2 Group	Experimental	Biological: RSV vaccine GSK3003898A (formulation 2)Subjects in this group will receive a single dose of formulation 2 of RSV vaccine
RSV vaccine formulation 3 Group	Experimental	Biological: RSV vaccine GSK3003899A (formulation 3)Subjects in this group will receive a single dose of formulation 3 of RSV vaccine
Boostrix Group	Active comparator	Biological: BoostrixSubjects in this group will receive a single dose of Boostrix

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (23 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RSV vaccine GSK3003895A (formulation 1)Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm	Biological	RSV vaccine formulation 1 Group
RSV vaccine GSK3003898A (formulation 2)Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm	Biological	RSV vaccine formulation 2 Group
RSV vaccine GSK3003899A (formulation 3)Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm	Biological	RSV vaccine formulation 3 Group
BoostrixSingle dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm	Biological	Boostrix Group

Primary outcome

Number of Subjects With Solicited Local Symptoms
Time frame: 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
Time frame: 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 Unsolicited Adverse Events (AEs)
Time frame: 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 Serious Adverse Events (SAEs)
Time frame: 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
Time frame: At Day 0 pre-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).
Titres of RSV-A Neutralizing Antibodies
Time frame: 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).

7 secondary outcomes

Titres of RSV-A Neutralizing Antibodies
Time frame: At Day 60 post-vaccination
Titres of RSV-A Neutralizing Antibodies
Time frame: At Day 90 post-vaccination
Concentrations of Palivizumab Competing Antibodies (PCA)
Time frame: At Day 0 pre-vaccination
Concentrations of PCA
Time frame: At Day 30 post-vaccination
Concentrations of PCA
Time frame: At Day 60 post-vaccination
Concentrations of PCA
Time frame: At Day 90 post-vaccination
Number of Subjects With SAEs
Time frame: Up to study end at Day 360

Results and safety

Results posted to the registry on 16 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK3003891A 30 Non-adjuvanted Group	126	122
GSK3003891A 60 Non-adjuvanted Group	124	111
GSK3003891A 60 Adjuvanted Group	125	117
Boostrix Group	125	120

Primary outcome: Number of Subjects With Solicited Local Symptoms

Time frame: During the 7-day (Days 0-6) post-vaccination period. Count of participants. Unit: Participants

Measure	GSK3003891A 30 Non-adjuvanted Group n = 124	GSK3003891A 60 Non-adjuvanted Group n = 119	GSK3003891A 60 Adjuvanted Group n = 124	Boostrix Group n = 124
Any Pain	62	68	104	104
Grade 3 Pain	1	2	9	3
Any Redness	6	3	8	6
Grade 3 Redness	0	0	0	0
Any Swelling	7	6	12	5
Grade 3 Swelling	0	0	0	0

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented and with the symptoms sheet filled in.

Primary outcome: Number of Subjects With Solicited General Symptoms

Time frame: During the 7-day (Days 0-6) post-vaccination period. Count of participants. Unit: Participants

Measure	GSK3003891A 30 Non-adjuvanted Group n = 124	GSK3003891A 60 Non-adjuvanted Group n = 119	GSK3003891A 60 Adjuvanted Group n = 124	Boostrix Group n = 124
Any Fatigue	53	50	56	45
G3 Fatigue	8	1	4	2
Related Fatigue	44	41	50	39
Any Gastro. symp.	16	19	23	20
G3 Gastro. symp.	1	2	1	0
Related Gastro. symp.	9	14	21	17
Any Headache	47	44	53	39
G3 Headache	3	2	5	3

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented and with the symptoms sheet filled in.

Primary outcome: Number of Subjects With Unsolicited Adverse Events (AEs)

Time frame: During the 30-Day (Days 0-29) post-vaccination period. Count of participants. Unit: Participants

Measure	GSK3003891A 30 Non-adjuvanted Group n = 126	GSK3003891A 60 Non-adjuvanted Group n = 124	GSK3003891A 60 Adjuvanted Group n = 125	Boostrix Group n = 125
Value	35	38	34	37

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented.

Primary outcome: Number of Subjects With Serious Adverse Events (SAEs)

Time frame: From vaccination at Day 0, up to Day 30 post-vaccination. Count of participants. Unit: Participants

Measure	GSK3003891A 30 Non-adjuvanted Group n = 126	GSK3003891A 60 Non-adjuvanted Group n = 124	GSK3003891A 60 Adjuvanted Group n = 125	Boostrix Group n = 125
Value	1	1	0	0

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited and Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK3003891A 30 Non-adjuvanted Group	3 of 126 (2.4%)	93 of 126 (73.8%)	0 of 126
GSK3003891A 60 Non-adjuvanted Group	3 of 124 (2.4%)	88 of 124 (71%)	0 of 124
GSK3003891A 60 Adjuvanted Group	6 of 125 (4.8%)	112 of 125 (89.6%)	0 of 125
Boostrix Group	2 of 125 (1.6%)	109 of 125 (87.2%)	0 of 125

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31951765Steff 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.
Derived from this study: PubMed 29401325Beran 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.
IPD for this study will be made available via the Clinical Study Data Request site.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

12 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Germany, Australia, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Solicited Local Symptoms (time frame: During the 7-day (Days 0-6) post-vaccination period). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02360475, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.