Respiratory Synctial Virus InfectionsPhase 1NCT02491463

A Study to Assess the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' RSV Investigational Vaccine (ChAd155-RSV) (GSK3389245A) in Healthy Adults

A Phase 1 study testing GSK3389245A_LD GROUP, GSK3389245A_HD GROUP and Bexsero in people with Respiratory Synctial Virus Infections, run by GlaxoSmithKline at 1 site in United Kingdom.

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 first time in human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of 2 doses of the RSV investigational vaccine, when administered intramuscularly according to a 0, 1 month schedule, in healthy adults aged 18 to 45 years. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Respiratory Synctial Virus Infections
What is being tested?: GSK3389245A_LD GROUP, GSK3389245A_HD GROUP and Bexsero
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 73 participants
Where: 1 siteUnited Kingdom
Study dates: 23 Jul 2015to 26 Jan 2017
Phase: Phase 1
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
All sexes
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
A male or female between, and including, 18 and 45 years of age at the time of first 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 vaccina-tion, and
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series

Who cannot join

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
Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines, or planned use during the study period
Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to 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 the first dose and ending 30 days after the last dose of vaccine administration, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before the first dose and ≥ 15 days after the last dose of study vaccine
Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccines or planned administration during the study period
Blood donation within 4 months prior to study entry or planned blood donation at any time during the study

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Previous vaccination against RSV
Previous vaccination with a recombinant simian or human adenoviral vaccine
Previous Bexsero or other vaccination against Neisseria meningitidis serogroup B
History of or current autoimmune disease
Family history of congenital or hereditary immunodefi-ciency
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
History of any neurological disorders or seizures
History of transient thrombocytopenia or neurological complications following any prior vaccination
Hypersensitivity to latex
Hypersensitivity to Bexsero's active substances or to any of its excipients
Allergic reaction to kanamycin
Any medical condition that in the judgment of the investi-gator would make intramuscular injection unsafe
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
Acute disease and/or fever at the time of enrolment
Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as de-termined by physical examination or laboratory screening tests
Malignancy within previous 5 years or lymphoproliferative disorders
Any clinically significant or any ≥ Grade 2 haematological laboratory abnormality
Body mass index > 40 kg/m2
Current alcohol and/or drug abuse
Pregnant or lactating female
Any other condition that the investigator judges may interfere with study procedures or findings
Planned move to a location that will prohibit participating in the trial until study end

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

GSK Investigational Site
Oxford, Oxfordshire, OX3 7LJ

Other trials in United Kingdom

About this study

Official title: A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in Healthy Adults

Conditions: Respiratory Synctial Virus Infections
Being tested: GSK3389245A_LD GROUP, GSK3389245A_HD GROUP, Bexsero, Placebo
Keywords: Reactogenicity, Safety, Respiratory syncytial virus (RSV), Vaccine, Immunogenicity

What participants receive

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

GSK3389245A_LD GROUPBiological
2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm
GSK3389245A_HD GROUPBiological
2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm
BexseroBiological
Also called Meningococcal group B Vaccine
2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm
PlaceboDrug
2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm

Study groups in NCT02491463
Study group	Role	What they receive
GSK3389245A_LD GROUP	Experimental	Subjects in this group will receive 2 doses, one month apart of the GSK3389245A vaccine low dose Receives: Biological: GSK3389245A_LD GROUP
GSK3389245A_HD GROUP	Experimental	Subjects in this group will receive 2 doses, one month apart, of the GSK3389245A vaccine high dose Receives: Biological: GSK3389245A_HD GROUP
Bexsero Group	Active comparator	Subjects in this group will receive 2 doses, one month apart, of Bexsero Receives: Biological: Bexsero
Placebo Group	Placebo comparator	Subjects in this group will receive 2 doses, one month apart, of placebo Receives: Drug: Placebo

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 = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. All solicited local symptoms are considered as related to the vaccination.
Measured: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)] gastrointestinal symptoms (gastro) [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 the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cells [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 1 (U-B), unknown at baseline and within at Day 1 (U-W), unknown at baseline and above at Day 1 (U-A), below at baseline and below at Day 1 (B-B), below at baseline and within at Day 1 (B-W), below at baseline and above at Day 1(B-A), within at baseline and below at Day 1 (W-B), within at baseline and within at Day 1(W-W), within at baseline and above at Day 1(W-A), above at baseline and below at Day 1(A-B), above at baseline and within at Day 1 (A-W), above at baseline and above at Day 1(A-A)
Measured: At Day 1
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Haematological/ Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 3 (U-B), unknown at baseline and within at Day 3 (U-W), unknown at baseline and above at Day 3 (U-A), below at baseline and below at Day 3 (B-B), below at baseline and within at Day 3 (B-W), below at baseline and above at Day 3(B-A), within at baseline and below at Day 3 (W-B), within at baseline and within at Day 3(W-W), within at baseline and above at Day 3(W-A), above at baseline and below at Day 3(A-B), above at baseline and within at Day 3(A-W), above at baseline and above at Day 3(A-A).
Measured: At Day 3
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Haematological/ Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 7 (U-B), unknown at baseline and within at Day 7 (U-W), unknown at baseline and above at Day 7 (U-A), below at baseline and below at Day 7 (B-B), below at baseline and within at Day 7 (B-W), below at baseline and above at Day 7(B-A), within at baseline and below at Day 7 (W-B), within at baseline and within at Day 7(W-W), within at baseline and above at Day 7(W-A), above at baseline and below at Day 7(A-B), above at baseline and within at Day 7(A-W), above at baseline and above at Day 7(A-A).
Measured: At Day 7
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 30(U-B), unknown at baseline and within at Day30(U-W), unknown at baseline and above at Day 30(U-A), below at baseline and below at Day30(B-B), below at baseline and within at Day30(B-W), below at baseline and above at Day 30(B-A), within at baseline and below at Day 30 (W-B), within at baseline and within at Day 30(W-W), within at baseline and above at Day30(W-A), above at baseline and below at Day30(A-B), above at baseline and within at Day30(A-W), above at baseline and above at Day30(A-A).
Measured: At Day 30
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 31(U-B), unknown at baseline and within at Day31(U-W), unknown at baseline and above at Day 31(U-A), below at baseline and below at Day31(B-B), below at baseline and within at Day31(B-W), below at baseline and above at Day 31(B-A), within at baseline and below at Day 31(W-B), within at baseline and within at Day 31(W-W), within at baseline and above at Day31(W-A), above at baseline and below at Day31(A-B), above at baseline and within at Day31(A-W), above at baseline and above at Day31(A-A).
Measured: At Day 31
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 33(U-B), unknown at baseline and within at Day33(U-W), unknown at baseline and above at Day 33(U-A), below at baseline and below at Day33(B-B), below at baseline and within at Day33(B-W), below at baseline and above at Day 33 (B-A), within at baseline and below at Day 33(W-B), within at baseline and within at Day 33(W-W), within at baseline and above at Day33(W-A), above at baseline and below at Day33(A-B), above at baseline and within at Day33(A-W), above at baseline and above at Day33(A-A).
Measured: At Day 33
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 37(U-B), unknown at baseline and within at Day37(U-W), unknown at baseline and above at Day 37(U-A), below at baseline and below at Day37(B-B), below at baseline and within at Day37(B-W), below at baseline and above at Day 37(B-A), within at baseline and below at Day 37(W-B), within at baseline and within at Day 37(W-W), within at baseline and above at Day37(W-A), above at baseline and below at Day37(A-B), above at baseline and within at Day37(A-W), above at baseline and above at Day37(A-A).
Measured: At Day 37
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 60(U-B), unknown at baseline and within at Day60(U-W), unknown at baseline and above at Day 60(U-A), below at baseline and below at Day60(B-B), below at baseline and within at Day60(B-W), below at baseline and above at Day60(B-A), within at baseline and below at Day 60(W-B), within at baseline and within at Day 60(W-W), within at baseline and above at Day60(W-A), above at baseline and below at Day60(A-B), above at baseline and within at Day60(A-W), above at baseline and above at Day60(A-A).
Measured: At Day 60
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day180(U-B), unknown at baseline and within at Day180(U-W), unknown at baseline and above at Day180(U-A), below at baseline and below at Day180(B-B), below at baseline and within at Day180(B-W),below at baseline and above at Day180(B-A), within at baseline and below at Day180(W-B),within at baseline and within at Day180(W-W), within at baseline and above at Day180(W-A),above at baseline and below at Day180(A-B),above at baseline and within at Day180(A-W),above at baseline and above at Day180(A-A).
Measured: At Day 180
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day360(U-B), unknown at baseline and within at Day360(U-W), unknown at baseline and above at Day360(U-A), below at baseline and below at Day360(B-B), below at baseline and within at Day360(B-W),below at baseline and above at Day360(B-A), within at baseline and below at Day360(W-B),within at baseline and within at Day360(W-W), within at baseline and above at Day360(W-A),above at baseline and below at Day360(A-B),above at baseline and within at Day360(A-W),above at baseline and above at Day360(A-A).
Measured: At Day 360
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
Parameters analysed were ALT, activated partial thromboplastin time [APTT], AST, total bilirubin [TB], CRE, EOS, haemoglobin decrease [HgD], LYM, NEU, platelets [PLA], PT, white blood cells decrease [WBCD] and white blood cells increase [WBCI]. Assessed grades were: Unknown [UG], grade 0 [G0] = no grade, 1 [G1] = mild grade, 2 [G2] = moderate grade, 3 [G3] = severe grade, 4 [G4] = potentially life threatening and overall grading [GTotal]. Parameter grade combinations expressed were: parameter plus UG/G0/1/2/3/4/Total at baseline versus grading G0/1/2/3/4/Total from Day 1 up to Day 60, for the same parameter, e.g. ALT G0-G2.
Measured: From Day 1 to Day 60
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 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 Day 0 to Day 360

Secondary outcomes (5)

Number of Subjects With Haematological and Biochemical Results by Maximum Grade
Parameters analysed were ALT, activated partial thromboplastin time [APTT], AST, total bilirubin [TB], CRE, EOS, haemoglobin decrease [HgD], LYM, NEU, platelets [PLA], PT, white blood cells decrease [WBCD] and white blood cells increase [WBCI]. Assessed grades were: Unknown [UG], grade 0 [G0] = no grade, 1 [G1] = mild grade, 2 [G2] = moderate grade, 3 [G3] = severe grade, 4 [G4] = potentially life threatening and overall grading [GTotal]. Parameter grade combinations expressed were: parameter plus UG/G0/1/2/3/4/Total at baseline versus grading G0/1/2/3/4/Total from Day 1 up to Day 360, for the same parameter, e.g. ALT G0-G2.
Measured: From Day 1 up to Day 360
Anti-respiratory Syncytial Virus (RSV) Neutralizing Antibodies Titers
Serum neutralizing antibody titers were reported as the inverse of the serum dilution which yielded a 60% reduction in the number of viral plaques compared to virus control without serum (Estimated Dilution: ED60). Antibody titers were expressed as Geometric Mean Titers (GMTs).
Measured: At pre-vaccination (Day 0), post-Dose 1 (Day 30) and post-Dose 2 (Day 60)
Number of Subjects With Anti-RSV Neutralizing Antibodies Above the Cut-off Value
Pre-defined cut-off values was higher than or equal to (≥) 8 ED60.
Measured: At pre-vaccination (Day 0), post-Dose 1 (Day 30) and post-Dose 2 (Day 60)
Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells
Interferon-gamma specific T-cells, expressed as T-cells per (/) million cells, were determined by the Enzyme Linked ImmunoSpot (ELISpot) assay.
Measured: At pre-vaccination (Day 0) and post-Dose 1 (Day 7, Day 30) and post-Dose 2 (Day 37, Day 60)
Frequency of Anti-F Immunoglobulin g (IgG) and/or Immunoglobulin A (IgA) Antibody Secreting B-cells (ASC)
IgG/IgA antibody specific B-cells/ expressed as B-cells per million cells, were determined by the ELISpot assay.
Measured: At pre-vaccination (Day 0) and post-Dose 1 (Day 7, Day 30) and post-Dose 2 (Day 37, Day 60)

Timeline

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

23 Jul 201526 Jan 2017

First posted8 Jul 2015 (estimated)
Study start23 Jul 2015
Primary completion8 Apr 2016
Study completion26 Jan 2017

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 Synctial 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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 73 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02491463
Sponsor's protocol ID: 201974
Status last verified: May 2018
First submitted: 29 Jun 2015
Last updated: 20 Aug 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Cicconi P, Jones C, Sarkar E, Silva-Reyes L, Klenerman P, de Lara C, Hutchings C, Moris P, Janssens M, Fissette LA, Picciolato M, Leach A, Gonzalez-Lopez A, Dieussaert I, Snape MD. First-in-Human Randomized Study to Assess the Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus (RSV) Vaccine Based on Chimpanzee-Adenovirus-155 Viral Vector-Expressing RSV Fusion, Nucleocapsid, and Antitermination Viral Proteins in Healthy Adults. Clin Infect Dis. 2020 May 6;70(10):2073-2081. doi: 10.1093/cid/ciz653.
PubMed 31340042

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?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in Healthy Adults
ClinicalTrials.gov ID: NCT02491463
Acronym / sponsor ID: 201974
Conditions: Respiratory Synctial Virus Infections
Keywords: Reactogenicity, Safety, Respiratory syncytial virus (RSV), Vaccine, Immunogenicity
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 73 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 23 Jul 2015 (actual)
Primary completion: 8 Apr 2016 (actual)
Study completion: 26 Jan 2017 (actual)
First posted: 8 Jul 2015 (estimated)
Results: Posted 20 Aug 2018

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
GSK3389245A_LD GROUP	Experimental	Biological: GSK3389245A_LD GROUPSubjects in this group will receive 2 doses, one month apart of the GSK3389245A vaccine low dose
GSK3389245A_HD GROUP	Experimental	Biological: GSK3389245A_HD GROUPSubjects in this group will receive 2 doses, one month apart, of the GSK3389245A vaccine high dose
Bexsero Group	Active comparator	Biological: BexseroSubjects in this group will receive 2 doses, one month apart, of Bexsero
Placebo Group	Placebo comparator	Drug: PlaceboSubjects in this group will receive 2 doses, one month apart, of placebo

Who may qualify

Ages: 18 to 45 years
Sex: All
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
A male or female between, and including, 18 and 45 years of age at the time of first 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 (28 listed)

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
Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines, or planned use during the study period
Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to 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 the first dose and ending 30 days after the last dose of vaccine administration, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before the first dose and ≥ 15 days after the last dose of study vaccine
Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccines or planned administration during the study period

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
GSK3389245A_LD GROUP2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm	Biological	GSK3389245A_LD GROUP
GSK3389245A_HD GROUP2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm	Biological	GSK3389245A_HD GROUP
BexseroAlso: Meningococcal group B Vaccine2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm	Biological	Bexsero Group
Placebo2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm	Drug	Placebo Group

Primary outcome

Number of Subjects With Solicited Local Symptoms
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
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 millimeters (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 the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)] gastrointestinal symptoms (gastro) [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 Haematological and Biochemical Laboratory Abnormalities
Time frame: At Day 1
Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cells [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 1 (U-B), unknown at baseline and within at Day 1 (U-W), unknown at baseline and above at Day 1 (U-A), below at baseline and below at Day 1 (B-B), below at baseline and within at Day 1 (B-W), below at baseline and above at Day 1(B-A), within at baseline and below at Day 1 (W-B), within at baseline and within at Day 1(W-W), within at baseline and above at Day 1(W-A), above at baseline and below at Day 1(A-B), above at baseline and within at Day 1 (A-W), above at baseline and above at Day 1(A-A)
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Time frame: At Day 3
Haematological/ Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 3 (U-B), unknown at baseline and within at Day 3 (U-W), unknown at baseline and above at Day 3 (U-A), below at baseline and below at Day 3 (B-B), below at baseline and within at Day 3 (B-W), below at baseline and above at Day 3(B-A), within at baseline and below at Day 3 (W-B), within at baseline and within at Day 3(W-W), within at baseline and above at Day 3(W-A), above at baseline and below at Day 3(A-B), above at baseline and within at Day 3(A-W), above at baseline and above at Day 3(A-A).
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Time frame: At Day 7
Haematological/ Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 7 (U-B), unknown at baseline and within at Day 7 (U-W), unknown at baseline and above at Day 7 (U-A), below at baseline and below at Day 7 (B-B), below at baseline and within at Day 7 (B-W), below at baseline and above at Day 7(B-A), within at baseline and below at Day 7 (W-B), within at baseline and within at Day 7(W-W), within at baseline and above at Day 7(W-A), above at baseline and below at Day 7(A-B), above at baseline and within at Day 7(A-W), above at baseline and above at Day 7(A-A).
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Time frame: At Day 30
Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 30(U-B), unknown at baseline and within at Day30(U-W), unknown at baseline and above at Day 30(U-A), below at baseline and below at Day30(B-B), below at baseline and within at Day30(B-W), below at baseline and above at Day 30(B-A), within at baseline and below at Day 30 (W-B), within at baseline and within at Day 30(W-W), within at baseline and above at Day30(W-A), above at baseline and below at Day30(A-B), above at baseline and within at Day30(A-W), above at baseline and above at Day30(A-A).
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Time frame: At Day 31
Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 31(U-B), unknown at baseline and within at Day31(U-W), unknown at baseline and above at Day 31(U-A), below at baseline and below at Day31(B-B), below at baseline and within at Day31(B-W), below at baseline and above at Day 31(B-A), within at baseline and below at Day 31(W-B), within at baseline and within at Day 31(W-W), within at baseline and above at Day31(W-A), above at baseline and below at Day31(A-B), above at baseline and within at Day31(A-W), above at baseline and above at Day31(A-A).
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Time frame: At Day 33
Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 33(U-B), unknown at baseline and within at Day33(U-W), unknown at baseline and above at Day 33(U-A), below at baseline and below at Day33(B-B), below at baseline and within at Day33(B-W), below at baseline and above at Day 33 (B-A), within at baseline and below at Day 33(W-B), within at baseline and within at Day 33(W-W), within at baseline and above at Day33(W-A), above at baseline and below at Day33(A-B), above at baseline and within at Day33(A-W), above at baseline and above at Day33(A-A).
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Time frame: At Day 37
Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 37(U-B), unknown at baseline and within at Day37(U-W), unknown at baseline and above at Day 37(U-A), below at baseline and below at Day37(B-B), below at baseline and within at Day37(B-W), below at baseline and above at Day 37(B-A), within at baseline and below at Day 37(W-B), within at baseline and within at Day 37(W-W), within at baseline and above at Day37(W-A), above at baseline and below at Day37(A-B), above at baseline and within at Day37(A-W), above at baseline and above at Day37(A-A).
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Time frame: At Day 60
Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 60(U-B), unknown at baseline and within at Day60(U-W), unknown at baseline and above at Day 60(U-A), below at baseline and below at Day60(B-B), below at baseline and within at Day60(B-W), below at baseline and above at Day60(B-A), within at baseline and below at Day 60(W-B), within at baseline and within at Day 60(W-W), within at baseline and above at Day60(W-A), above at baseline and below at Day60(A-B), above at baseline and within at Day60(A-W), above at baseline and above at Day60(A-A).
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Time frame: At Day 180
Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day180(U-B), unknown at baseline and within at Day180(U-W), unknown at baseline and above at Day180(U-A), below at baseline and below at Day180(B-B), below at baseline and within at Day180(B-W),below at baseline and above at Day180(B-A), within at baseline and below at Day180(W-B),within at baseline and within at Day180(W-W), within at baseline and above at Day180(W-A),above at baseline and below at Day180(A-B),above at baseline and within at Day180(A-W),above at baseline and above at Day180(A-A).
Number of Subjects With Haematological and Biochemical Laboratory Abnormalities
Time frame: At Day 360
Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day360(U-B), unknown at baseline and within at Day360(U-W), unknown at baseline and above at Day360(U-A), below at baseline and below at Day360(B-B), below at baseline and within at Day360(B-W),below at baseline and above at Day360(B-A), within at baseline and below at Day360(W-B),within at baseline and within at Day360(W-W), within at baseline and above at Day360(W-A),above at baseline and below at Day360(A-B),above at baseline and within at Day360(A-W),above at baseline and above at Day360(A-A).
Number of Subjects With Haematological and Biochemical Results by Maximum Grade
Time frame: From Day 1 to Day 60
Parameters analysed were ALT, activated partial thromboplastin time [APTT], AST, total bilirubin [TB], CRE, EOS, haemoglobin decrease [HgD], LYM, NEU, platelets [PLA], PT, white blood cells decrease [WBCD] and white blood cells increase [WBCI]. Assessed grades were: Unknown [UG], grade 0 [G0] = no grade, 1 [G1] = mild grade, 2 [G2] = moderate grade, 3 [G3] = severe grade, 4 [G4] = potentially life threatening and overall grading [GTotal]. Parameter grade combinations expressed were: parameter plus UG/G0/1/2/3/4/Total at baseline versus grading G0/1/2/3/4/Total from Day 1 up to Day 60, for the same parameter, e.g. ALT G0-G2.
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 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 Day 0 to Day 360
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.

5 secondary outcomes

Number of Subjects With Haematological and Biochemical Results by Maximum Grade
Time frame: From Day 1 up to Day 360
Anti-respiratory Syncytial Virus (RSV) Neutralizing Antibodies Titers
Time frame: At pre-vaccination (Day 0), post-Dose 1 (Day 30) and post-Dose 2 (Day 60)
Number of Subjects With Anti-RSV Neutralizing Antibodies Above the Cut-off Value
Time frame: At pre-vaccination (Day 0), post-Dose 1 (Day 30) and post-Dose 2 (Day 60)
Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells
Time frame: At pre-vaccination (Day 0) and post-Dose 1 (Day 7, Day 30) and post-Dose 2 (Day 37, Day 60)
Frequency of Anti-F Immunoglobulin g (IgG) and/or Immunoglobulin A (IgA) Antibody Secreting B-cells (ASC)
Time frame: At pre-vaccination (Day 0) and post-Dose 1 (Day 7, Day 30) and post-Dose 2 (Day 37, Day 60)

Results and safety

Results posted to the registry on 20 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK3389245A_LD Group	7	5
GSK3389245A_HD Group	31	21
Placebo Group	19	15
Bexsero Group	15	14

Primary outcome: Number of Subjects With Solicited Local Symptoms

Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses. Count of participants. Unit: Participants

Measure	GSK3389245A_LD Group n = 7	GSK3389245A_HD Group n = 30	Placebo Group n = 19	Bexsero Group n = 15
Any Pain Dose 1	2	23	1	15
Grade 3 Pain Dose 1	0	1	0	3
Any Redness Dose 1	0	0	0	0
Grade 3 Redness Dose 1	0	0	0	0
Any Swelling Dose 1	0	0	0	0
Grade 3 Swelling Dose 1	0	0	0	0
Any Pain Dose 2	2	19	0	15
Grade 3 Pain Dose 2	0	1	0	2

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented, who had filled in their symptom sheets.

Primary outcome: Number of Subjects With Solicited General Symptoms

Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses. Count of participants. Unit: Participants

Measure	GSK3389245A_LD Group n = 7	GSK3389245A_HD Group n = 30	Placebo Group n = 19	Bexsero Group n = 15
Any Fatigue Dose 1	3	19	8	8
Grade 3 Fatigue Dose 1	0	0	0	0
Related Fatigue Dose 1	3	19	8	8
Any Gastro Dose 1	2	5	6	3
Grade 3 Gastro Dose 1	0	0	0	0
Related Gastro Dose 1	2	5	6	3
Any Headache Dose 1	5	14	8	10
Grade 3 Headache Dose 1	1	0	0	0

Population analysed: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented, who had filled in their symptom sheets.

Primary outcome: Number of Subjects With Haematological and Biochemical Laboratory Abnormalities

Time frame: At Day 1. Count of participants. Unit: Participants

Measure	GSK3389245A_LD Group n = 7	GSK3389245A_HD Group n = 31	Placebo Group n = 19	Bexsero Group n = 15
PTT, U-B	0	0	0	0
PTT, U-W	0	1	0	0
PTT, U-A	0	0	0	0
PTT, B-B	0	0	0	0
PTT, B-W	0	0	0	0
PTT, B-A	0	0	0	0
PTT, W-B	0	0	0	0
PTT, W-W	7	29	18	11

Population analysed: The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 1.

Primary outcome: Number of Subjects With Haematological and Biochemical Laboratory Abnormalities

Time frame: At Day 3. Count of participants. Unit: Participants

Measure	GSK3389245A_LD Group n = 7	GSK3389245A_HD Group n = 30	Placebo Group n = 19	Bexsero Group n = 15
PTT, U-B	0	0	0	0
PTT, U-W	0	1	0	0
PTT, U-A	0	0	0	0
PTT, B-B	0	0	0	0
PTT, B-W	0	0	0	0
PTT, B-A	0	0	0	0
PTT, W-B	0	0	0	0
PTT, W-W	7	29	18	11

5 secondary outcomes are reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
GSK3389245A_LD Group	1 of 7 (14.3%)	7 of 7 (100%)	0 of 7
GSK3389245A_HD Group	0 of 31 (0%)	30 of 31 (96.8%)	0 of 31
Placebo Group	1 of 19 (5.3%)	17 of 19 (89.5%)	0 of 19
Bexsero Group	0 of 15 (0%)	15 of 15 (100%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31340042Cicconi P, Jones C, Sarkar E, Silva-Reyes L, Klenerman P, de Lara C, Hutchings C, Moris P, Janssens M, Fissette LA, Picciolato M, Leach A, Gonzalez-Lopez A, Dieussaert I, Snape MD. First-in-Human Randomized Study to Assess the Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus (RSV) Vaccine Based on Chimpanzee-Adenovirus-155 Viral Vector-Expressing RSV Fusion, Nucleocapsid, and Antitermination Viral Proteins in Healthy Adults. Clin Infect Dis. 2020 May 6;70(10):2073-2081. doi: 10.1093/cid/ciz653.

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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 1 study testing GSK3389245A_LD GROUP, GSK3389245A_HD GROUP and Bexsero in people with Respiratory Synctial Virus Infections, run by GlaxoSmithKline at 1 site in United Kingdom.

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 28 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 20 Aug 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 20 Aug 2018). 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 following each dose and across doses). The study lists 15 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 NCT02491463, 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 20 Aug 2018.