Respiratory Syncytial Virus InfectionsPhase 2NCT02753413

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

A Phase 2 study testing RSV vaccine GSK3003891A and Boostrix in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 1 site in Belgium.

Completed

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

Official record

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Trial summary

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. 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 GSK3003891A and Boostrix
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 1 siteBelgium
Study dates: 1 Apr 2016to 28 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 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:

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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.

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.
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.

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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.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

GSK Investigational Site
Wilrijk, 2610

Other trials in Belgium

About this study

Official title: An Observer-blind Safety and Reactogenicity Study to Assess GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A) in Healthy Women

Conditions: Respiratory Syncytial Virus Infections
Being tested: RSV vaccine GSK3003891A, Boostrix
Keywords: Vaccine, Safety, Reactogenicity, Respiratory syncytial virus (RSV)
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 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.

Study groups in NCT02753413
Study group	Role	What they receive
RSV group	Experimental	Subjects in this group will receive a single dose of the RSV vaccine. Receives: Biological: RSV vaccine GSK3003891A
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 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.
Measured: At Day 7
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.
Measured: 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.
Measured: At Day 7
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.
Measured: 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 LYM, NEU and PLT
Measured: At Day 7
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 LYM, NEU and PLT.
Measured: At Day 30
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
Among biochemical parameters tested were ALT, AST and CRE, graded by FDA toxicity grading for biochemistry parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.
Measured: From Day 7 up to Day 30
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Among haematological parameters tested were EOS, decreased Hgb and LYM graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.
Measured: From Day 7 up to Day 30
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Among haematological parameters tested were NEU, PLT, decreased WBC and increased WBC/I, graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.
Measured: From Day 7 up to Day 30
Number of Subjects With Haematology Change From Baseline by Maximum Grade
Assessed laboratory parameter changed from baseline was haemoglobin (Hgb). FDA grading for Hgb (change from baseline) was not applicable a baseline.
Measured: From Day 7 up to Day 30
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 = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimetres (mm) of injection site. All solicited local symptoms are considered as related to the vaccination.
Measured: During a 7-day follow-up period (from Day 0 to Day 6) after vaccination
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were fatigue, temperature (defined as oral temperature equal to or above [≥] 37.5 degrees Celsius [°C] for oral, axillary or tympanic route), gastrointestinal symptoms (gastro) including nausea, vomiting, diarrhoea and/or abdominal pain; and headache. Any = occurrence of the symptom regardless of intensity grade and relationship to the vaccination. Grade 3 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 a 7-day follow-up period (from Day 0 to Day 6) after vaccination
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 out-side 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 a 30-day follow-up period (from Day 0 to Day 29) after vaccination
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 (Day 0) up to study end (Day 30)

Timeline

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

1 Apr 201628 Jun 2016

First posted27 Apr 2016 (estimated)
Study start1 Apr 2016
Primary completion28 Jun 2016
Study completion28 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 (1)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: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02753413
Sponsor's protocol ID: 204813
Other IDs: 2015-005742-58, 2015
Status last verified: May 2018
First submitted: 21 Apr 2016
Last updated: 26 Jun 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

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
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
RecruitingObservational study
TARSILA Real-World Evidence Study
Respiratory Syncytial Virus (RSV), Maternal Immunization

All Respiratory Syncytial Virus Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observer-blind Safety and Reactogenicity Study to Assess GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A) in Healthy Women
ClinicalTrials.gov ID: NCT02753413
Acronym / sponsor ID: 204813
Conditions: Respiratory Syncytial Virus Infections
Keywords: Vaccine, Safety, Reactogenicity, Respiratory syncytial virus (RSV)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Apr 2016
Primary completion: 28 Jun 2016 (actual)
Study completion: 28 Jun 2016 (actual)
First posted: 27 Apr 2016 (estimated)
Results: Posted 11 Jul 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: 2

Arm	Type	Receives
RSV group	Experimental	Biological: RSV vaccine GSK3003891ASubjects in this group will receive a single dose of the 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 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 (24 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.
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.

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 GSK3003891ASingle dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.	Biological	RSV 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 Abnormal Biochemical Laboratory Values.
Time frame: At Day 7
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.
Number of Subjects With Abnormal Biochemical Laboratory Values.
Time frame: At Day 30
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.
Number of Subjects With Abnormal Haematological Laboratory Values.
Time frame: At Day 7
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.
Number of Subjects With Abnormal Haematological Laboratory Values.
Time frame: At Day 30
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.
Number of Subjects With Abnormal Haematological Laboratory Values.
Time frame: At Day 7
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 LYM, NEU and PLT
Number of Subjects With Abnormal Haematological Laboratory Values.
Time frame: At Day 30
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 LYM, NEU and PLT.
Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading
Time frame: From Day 7 up to Day 30
Among biochemical parameters tested were ALT, AST and CRE, graded by FDA toxicity grading for biochemistry parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Time frame: From Day 7 up to Day 30
Among haematological parameters tested were EOS, decreased Hgb and LYM graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.
Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading
Time frame: From Day 7 up to Day 30
Among haematological parameters tested were NEU, PLT, decreased WBC and increased WBC/I, graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.
Number of Subjects With Haematology Change From Baseline by Maximum Grade
Time frame: From Day 7 up to Day 30
Assessed laboratory parameter changed from baseline was haemoglobin (Hgb). FDA grading for Hgb (change from baseline) was not applicable a baseline.
Number of Subjects With Solicited Local Symptoms
Time frame: During a 7-day follow-up period (from Day 0 to Day 6) after vaccination
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimetres (mm) of injection site. All solicited local symptoms are considered as related to the vaccination.
Number of Subjects With Solicited General Symptoms
Time frame: During a 7-day follow-up period (from Day 0 to Day 6) after vaccination
Assessed solicited general symptoms were fatigue, temperature (defined as oral temperature equal to or above [≥] 37.5 degrees Celsius [°C] for oral, axillary or tympanic route), gastrointestinal symptoms (gastro) including nausea, vomiting, diarrhoea and/or abdominal pain; and headache. Any = occurrence of the symptom regardless of intensity grade and relationship to the vaccination. Grade 3 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 a 30-day follow-up period (from Day 0 to Day 29) after vaccination
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 out-side 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 (Day 0) up to study end (Day 30)
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.

Results and safety

Results posted to the registry on 11 Jul 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 Group	49	49
Boostrix Group	51	51

Primary outcome: Number of Subjects With Abnormal Biochemical Laboratory Values.

Time frame: At Day 7. Count of participants. Unit: Participants

Measure	GSK3003891A Group n = 49	Boostrix Group n = 51
ALT, Within-Bellow	0	0
ALT, Within-Within	48	50
ALT, Within-Above	1	1
AST, Within-Below	0	0
AST, Within-Within	48	48
AST, Within-Above	0	3
AST, Above-Below	0	0
AST, Above-Within	0	0

Population analysed: The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.

Primary outcome: Number of Subjects With Abnormal Biochemical Laboratory Values.

Time frame: At Day 30. Count of participants. Unit: Participants

Measure	GSK3003891A Group n = 49	Boostrix Group n = 51
ALT, Within-Bellow	0	0
ALT, Within-Within	48	51
ALT, Within-Above	1	0
AST, Within-Below	0	0
AST, Within-Within	47	51
AST, Within-Above	1	0
AST, Above-Below	0	0
AST, Above-Within	0	0

Population analysed: The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.

Primary outcome: Number of Subjects With Abnormal Haematological Laboratory Values.

Time frame: At Day 7. Count of participants. Unit: Participants

Measure	GSK3003891A Group n = 48	Boostrix Group n = 50
EOS, Within-Bellow	0	0
EOS, Within-Within	46	45
EOS, Within-Above	2	2
EOS, Above-Below	0	0
EOS, Above-Within	0	2
EOS, Above-Above	1	2
Hgb, Below-Below	0	1
Hgb, Below-Within	1	0

Population analysed: The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.

Primary outcome: Number of Subjects With Abnormal Haematological Laboratory Values.

Time frame: At Day 30. Count of participants. Unit: Participants

Measure	GSK3003891A Group n = 48	Boostrix Group n = 50
EOS, Within-Bellow	0	0
EOS, Within-Within	41	44
EOS, Within-Above	7	3
EOS, Above-Below	0	0
EOS, Above-Within	0	3
EOS, Above-Above	1	1
Hgb, Below-Below	0	1
Hgb, Below-Within	1	0

Population analysed: The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.

Adverse events

Time frame: Solicited and unsolicited AEs during the 30-Day follow-up period after vaccination; SAEs from Day 0 up to study end Day 30.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK3003891A Group	0 of 49 (0%)	27 of 49 (55.1%)	0 of 49
Boostrix Group	0 of 51 (0%)	46 of 51 (90.2%)	0 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RSV vaccine GSK3003891A and Boostrix in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 1 site in Belgium.

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 24 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 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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 11 Jul 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 Abnormal Biochemical Laboratory Values. (time frame: At Day 7). The study lists 14 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 NCT02753413, which also lists 1 linked publication.

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 26 Jun 2018.