Who is sponsoring NCT04090658?

NCT04090658 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT04090658?

Interventions in NCT04090658: RSV_PreF3 Vaccine (GSK3844766A) adjuvanted with AS01B, Placebo.

What condition does NCT04090658 study?

NCT04090658 studies Respiratory Syncytial Virus Infections.

Is NCT04090658 still recruiting?

NCT04090658 is currently completed. Last updated 25 February 2022.

Are results published for NCT04090658?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-02-25 · How we verify

NCT04090658

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Test GlaxoSmithKline's (GSK) Respiratory Syncytial Virus RSV Candidate Vaccine's Safety and Immune Response in Japanese Older Adults

Completed Phase 1 Results posted Last updated 25 February 2022

What this trial tests

Phase 1 trial testing RSV_PreF3 Vaccine (GSK3844766A) adjuvanted with AS01B in Respiratory Syncytial Virus Infections in 40 participants. Completed in 11 December 2020.

Timeline

25 September 2019

Primary endpoint
10 January 2020

11 December 2020

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	40
Start date	25 September 2019
Primary completion	10 January 2020
Estimated completion	11 December 2020
Sites	1 location across Japan

Drugs / interventions tested

RSV_PreF3 Vaccine (GSK3844766A) adjuvanted with AS01B — full drug profile →
Placebo

Conditions studied

Respiratory Syncytial Virus Infections — all drugs for Respiratory Syncytial Virus Infections →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 60 to 80, any sex, with Respiratory Syncytial Virus Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose of Vaccination Primary · During a 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after first dose of vaccination administered at Day 1

Assessed solicited local AEs at injection site are pain, erythema and swelling. Any erythema/swelling is scored with a diameter larger than (\>) 20 millimeters (mm).

Erythema

Group	Value	95% CI
RSV_PreF3_AS01B Group	1
Placebo Group	0

Pain

Group	Value	95% CI
RSV_PreF3_AS01B Group	17
Placebo Group	1

Swelling

Group	Value	95% CI
RSV_PreF3_AS01B Group	2
Placebo Group	0

Number of Subjects With Solicited Local AEs After Second Dose of Vaccination Primary · During a 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after second dose of vaccination administered at Day 61

Assessed solicited local AEs at injection site are pain, erythema and swelling. Any erythema/swelling was scored with a diameter larger than (\>) 20 millimeters (mm).

Erythema

Group	Value	95% CI
RSV_PreF3_AS01B Group	0
Placebo Group	0

Pain

Group	Value	95% CI
RSV_PreF3_AS01B Group	17
Placebo Group	4

Swelling

Group	Value	95% CI
RSV_PreF3_AS01B Group	0
Placebo Group	0

Number of Subjects With Solicited General AEs After First Dose of Vaccination Primary · During a 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after first dose of vaccination administered at Day 1

Assessed solicited general AEs solicited were: arthralgia; fatigue; fever (any temperature greater than or equal to 38.0 °C - the preferred location for measuring temperature being the oral cavity); gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain); headache; myalgia and shivering.

Arthralgia

Group	Value	95% CI
RSV_PreF3_AS01B Group	1
Placebo Group	0

Fatigue

Group	Value	95% CI
RSV_PreF3_AS01B Group	9
Placebo Group	2

Fever

Group	Value	95% CI
RSV_PreF3_AS01B Group	0
Placebo Group	0

Gastrointestinal symptoms

Group	Value	95% CI
RSV_PreF3_AS01B Group	1
Placebo Group	1

Headache

Group	Value	95% CI
RSV_PreF3_AS01B Group	2
Placebo Group	2

Myalgia

Group	Value	95% CI
RSV_PreF3_AS01B Group	6
Placebo Group	0

Shivering

Group	Value	95% CI
RSV_PreF3_AS01B Group	1
Placebo Group	0

Number of Subjects With Solicited General AEs After Second Dose of Vaccination Primary · During a 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after second dose of vaccination administered at Day 61

Assessed solicited general AEs solicited are: arthralgia; fatigue; fever (any temperature greater than or equal to 38.0 °C - the preferred location for measuring temperature being the oral cavity); gastrointestinal symptoms including (nausea, vomiting, diarrhea and/or abdominal pain); headache; myalgia and shivering.

Arthralgia

Group	Value	95% CI
RSV_PreF3_AS01B Group	5
Placebo Group	0

Fatigue

Group	Value	95% CI
RSV_PreF3_AS01B Group	9
Placebo Group	1

Fever

Group	Value	95% CI
RSV_PreF3_AS01B Group	4
Placebo Group	0

Gastrointestinal symptoms

Group	Value	95% CI
RSV_PreF3_AS01B Group	0
Placebo Group	1

Headache

Group	Value	95% CI
RSV_PreF3_AS01B Group	5
Placebo Group	1

Myalgia

Group	Value	95% CI
RSV_PreF3_AS01B Group	5
Placebo Group	1

Shivering

Group	Value	95% CI
RSV_PreF3_AS01B Group	4
Placebo Group	0

Number of Subjects With Unsolicited AEs After Any Vaccination Primary · During a 30-day follow-up period (i.e., on the day of vaccination and 29 subsequent days) after any vaccination (across doses)

An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.

Group	Value	95% CI
RSV_PreF3_AS01B Group	7
Placebo Group	6

Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Primary · At 7 days after the first vaccine dose (i.e. at Day 8 versus Day 1)

Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 1 (pre-vaccination dose 1=baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: \<parameter\>-\<range at baseline\>-\<range at timing\> (e.g. ALT-Within-Within). Ranges level being classified as belo

ALT-Above-Above

Group	Value	95% CI
RSV_PreF3_AS01B Group	1
Placebo Group	0

ALT-Within-Within

Group	Value	95% CI
RSV_PreF3_AS01B Group	19
Placebo Group	20

AST-Within-Above

Group	Value	95% CI
RSV_PreF3_AS01B Group	0
Placebo Group	1

AST-Within-Within

Group	Value	95% CI
RSV_PreF3_AS01B Group	20
Placebo Group	19

Basophils-Within-Within

Group	Value	95% CI
RSV_PreF3_AS01B Group	20
Placebo Group	20

Creatinine-Within-Below

Group	Value	95% CI
RSV_PreF3_AS01B Group	1
Placebo Group	0

Creatinine-Within-Within

Group	Value	95% CI
RSV_PreF3_AS01B Group	19
Placebo Group	20

Eosinophils-Below-Below

Group	Value	95% CI
RSV_PreF3_AS01B Group	3
Placebo Group	1

Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Primary · At 7 days after the second vaccine dose (i.e at Day 68 versus Day 61)

Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 61 (pre-vaccination dose 2=baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: \<parameter\>-\<range at baseline\>-\<range at timing\> (e.g. ALT-Within-Within). Ranges level being classified as be

ALT-Within-Within

Group	Value	95% CI
RSV_PreF3_AS01B Group	20
Placebo Group	20

AST-Within-Above

Group	Value	95% CI
RSV_PreF3_AS01B Group	0
Placebo Group	1

AST-Within-Within

Group	Value	95% CI
RSV_PreF3_AS01B Group	20
Placebo Group	19

Basophils-Within-Within

Group	Value	95% CI
RSV_PreF3_AS01B Group	20
Placebo Group	20

Creatinine-Below-Below

Group	Value	95% CI
RSV_PreF3_AS01B Group	0
Placebo Group	1

Creatinine-Within-Above

Group	Value	95% CI
RSV_PreF3_AS01B Group	0
Placebo Group	1

Creatinine-Within-Below

Group	Value	95% CI
RSV_PreF3_AS01B Group	1
Placebo Group	0

Creatinine-Within-Within

Group	Value	95% CI
RSV_PreF3_AS01B Group	19
Placebo Group	18

Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After First Dose of Vaccination Primary · During a 30-day follow-up period (i.e., on the day of vaccination at Day 1, and 29 subsequent days) after first vaccination

A Grade 3 AE is any AE assessed as severe, i.e. which prevents normal, everyday activities. In adults, such an AE would, for example, prevent attendance at work and would necessitate the administration of corrective therapy.

Any adverse event

Group	Value	95% CI
RSV_PreF3_AS01B Group	0
Placebo Group	0

General adverse event

Group	Value	95% CI
RSV_PreF3_AS01B Group	0
Placebo Group	0

Local adverse event

Group	Value	95% CI
RSV_PreF3_AS01B Group	0
Placebo Group	0

Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After Second Dose of Vaccination Primary · During a 30-day follow-up period (i.e., on the day of vaccination at Day 61, and 29 subsequent days) after second vaccination

Any adverse event

Group	Value	95% CI
RSV_PreF3_AS01B Group	2
Placebo Group	0

General adverse event

Group	Value	95% CI
RSV_PreF3_AS01B Group	1
Placebo Group	0

Local adverse event

Group	Value	95% CI
RSV_PreF3_AS01B Group	1
Placebo Group	0

Number of Subjects With Any Serious Adverse Events (SAEs) up to 30 Days After the Second Vaccination Primary · From Day 1 up to 30 days after the second vaccination (Day 91)

A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity.

Group	Value	95% CI
RSV_PreF3_AS01B Group	0
Placebo Group	1

Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) up to 30 Days After the Second Vaccination Primary · From Day 1 up to 30 days after the second vaccination (Day 91)

pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology

Group	Value	95% CI
RSV_PreF3_AS01B Group	0
Placebo Group	0

Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of Neutralizing Antibody Titers Against RSV- Serotype A Secondary · At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91)

Serological assays for the determination of functional antibodies against RSV-A were performed by neutralization assay. Anti RSV-A neutralizing antibody titers are given as geometric mean titers (GMTs) and expressed as Estimated Dose: serum dilution giving a 60% reduction of the signal compared to a control without serum (ED60). The cut-off of the assay is 18 ED60.

Day 1

Group	Value	95% CI
RSV_PreF3_AS01B Group	727.3	445.6 – 1187.3
Placebo Group	656	464.7 – 926.2

Day 31

Group	Value	95% CI
RSV_PreF3_AS01B Group	5315	3452.8 – 8181.5
Placebo Group	582.3	372.1 – 911.2

Day 61

Group	Value	95% CI
RSV_PreF3_AS01B Group	4382.8	2828.1 – 6792.1
Placebo Group	646.1	442.6 – 943.1

Day 91

Group	Value	95% CI
RSV_PreF3_AS01B Group	4605.2	3031.2 – 6996.4
Placebo Group	529.9	352.4 – 796.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

RSV_PreF3_AS01B Group

Serious: 0/20 (0%)

Deaths: 0/20

Placebo Group

Serious: 1/20 (5%)

Deaths: 0/20

Serious adverse events (2 terms)

Reaction	System	RSV_PreF3_AS01B Group	Placebo Group
Radius fracture	Injury, poisoning and procedural complications	—	—
Ulna fracture	Injury, poisoning and procedural complications	—	—

Other adverse events (21 terms — click to expand)

Reaction	System	RSV_PreF3_AS01B Group	Placebo Group
Injection site pain	General disorders	—	—
Fatigue	General disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Headache	Nervous system disorders	—	—
Chills	General disorders	—	—
Pyrexia	General disorders	—	—
Injection site swelling	General disorders	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—
Gastrointestinal disorder	Gastrointestinal disorders	—	—
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	—	—
Sneezing	Respiratory, thoracic and mediastinal disorders	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Toothache	Gastrointestinal disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Rhinitis	Infections and infestations	—	—
Tonsillitis	Infections and infestations	—	—
Eosinophil count increased	Investigations	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Radius fracture, Ulna fracture.

Data from ClinicalTrials.gov NCT04090658 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 doses of GSK Biologicals' RSV candidate vaccine adjuvanted with AS01B for the prevention of lower respiratory tract diseases caused by RSV in ethnic Japanese adults 60-80 years of age.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Respiratory syncytial virus prevention within reach: the vaccine and monoclonal antibody landscape.
Mazur NI, Terstappen J, Baral R, Bardají A, et al · · 2023 · cited 294× · PMID 35952703 · DOI 10.1016/s1473-3099(22)00291-2
Respiratory Syncytial Virus Vaccines: A Review of the Candidates and the Approved Vaccines.
Topalidou X, Kalergis AM, Papazisis G. · · 2023 · cited 84× · PMID 37887775 · DOI 10.3390/pathogens12101259
Recent Advances in the Development of Toll-like Receptor Agonist-Based Vaccine Adjuvants for Infectious Diseases.
Yang JX, Tseng JC, Yu GY, Luo Y, et al · · 2022 · cited 81× · PMID 35214155 · DOI 10.3390/pharmaceutics14020423
Respiratory syncytial virus: from pathogenesis to potential therapeutic strategies.
Shang Z, Tan S, Ma D. · · 2021 · cited 74× · PMID 34671221 · DOI 10.7150/ijbs.64762
Current State and Challenges in Developing Respiratory Syncytial Virus Vaccines.
Biagi C, Dondi A, Scarpini S, Rocca A, et al · · 2020 · cited 45× · PMID 33187337 · DOI 10.3390/vaccines8040672
Efficacy, immunogenicity and safety of respiratory syncytial virus prefusion F vaccine: systematic review and meta-analysis.
Pang Y, Lu H, Cao D, Zhu X, et al · · 2024 · cited 15× · PMID 38711074 · DOI 10.1186/s12889-024-18748-8
Safety and immunogenicity of a respiratory syncytial virus prefusion F protein (RSVPreF3) candidate vaccine in older Japanese adults: A phase I, randomized, observer-blind clinical trial.
Kotb S, Haranaka M, Folschweiller N, Nakanwagi P, et al · · 2023 · cited 13× · PMID 36641341 · DOI 10.1016/j.resinv.2022.11.003
Global progress in clinical research on human respiratory syncytial virus vaccines.
Peng R, Chen C, Chen Q, Zhang Y, et al · · 2024 · cited 8× · PMID 39286350 · DOI 10.3389/fmicb.2024.1457703

Verify or expand the search:

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Other GlaxoSmithKline trials

Trials by the same sponsor.

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NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
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NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04090658 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 25 February 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04090658.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing