Who is sponsoring NCT03814590?

NCT03814590 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT03814590?

Interventions in NCT03814590: RSV Vaccine (GSK3844766A) unadjuvanted low dose, RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, RSV Vaccine (GSK3844766A) unadjuvanted medium dose, RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, RSV Vaccine (GSK3844766A) unadjuvanted high dose, RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, Placebo (Saline solution).

What condition does NCT03814590 study?

NCT03814590 studies Respiratory Syncytial Virus Infections.

Is NCT03814590 still recruiting?

NCT03814590 is currently completed. Last updated 5 August 2022.

Are results published for NCT03814590?

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

Last reviewed 2022-08-05 · How we verify

NCT03814590

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

A Study to Assess the Safety, Reactogenicity and Immune Response of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3844766A) in Older Adults

Completed Phase 1, PHASE2 Results posted Last updated 5 August 2022

What this trial tests

Phase 1, PHASE2 trial testing RSV Vaccine (GSK3844766A) unadjuvanted low dose in Respiratory Syncytial Virus Infections in 1,053 participants. Completed in 30 November 2020.

Timeline

21 January 2019

Primary endpoint
12 December 2019

30 November 2020

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	1,053
Start date	21 January 2019
Primary completion	12 December 2019
Estimated completion	30 November 2020
Sites	21 locations across Belgium, United States

Drugs / interventions tested

RSV Vaccine (GSK3844766A) unadjuvanted low dose — full drug profile →
RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E — full drug profile →
RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B — full drug profile →
RSV Vaccine (GSK3844766A) unadjuvanted medium dose
RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E — full drug profile →
RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B
RSV Vaccine (GSK3844766A) unadjuvanted high dose
RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E
RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B — full drug profile →
Placebo (Saline solution)

Conditions studied

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

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 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 Any Solicited Local Symptoms After First Vaccination Dose Primary · During a 7-day follow-up period after first vaccination dose (i.e., on the day of vaccination [at Day 1] and 6 subsequent days)

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

Erythema

Group	Value	95% CI
Low Dose_PLAIN_A Group	0
Medium Dose_PLAIN_A Group	1
High Dose_PLAIN_A Group	0
Placebo_A Group	0
Low Dose_PLAIN_B Group	0
Medium Dose_PLAIN_B Group	1
High Dose_PLAIN_B Group	2
Low Dose_AS01E_B Group	5
Medium Dose_AS01E_B Group	6
High Dose_AS01E_B Group	9
Low Dose_AS01B_B Group	16
Medium Dose_AS01B_B Group	15

Pain

Group	Value	95% CI
Low Dose_PLAIN_A Group	1
Medium Dose_PLAIN_A Group	7
High Dose_PLAIN_A Group	6
Placebo_A Group	0
Low Dose_PLAIN_B Group	9
Medium Dose_PLAIN_B Group	5
High Dose_PLAIN_B Group	14
Low Dose_AS01E_B Group	54
Medium Dose_AS01E_B Group	57
High Dose_AS01E_B Group	56
Low Dose_AS01B_B Group	78
Medium Dose_AS01B_B Group	63

Swelling

Group	Value	95% CI
Low Dose_PLAIN_A Group	0
Medium Dose_PLAIN_A Group	0
High Dose_PLAIN_A Group	0
Placebo_A Group	0
Low Dose_PLAIN_B Group	0
Medium Dose_PLAIN_B Group	0
High Dose_PLAIN_B Group	2
Low Dose_AS01E_B Group	7
Medium Dose_AS01E_B Group	7
High Dose_AS01E_B Group	6
Low Dose_AS01B_B Group	10
Medium Dose_AS01B_B Group	7

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

Erythema

Group	Value	95% CI
Low Dose_PLAIN_A Group	0
Medium Dose_PLAIN_A Group	0
High Dose_PLAIN_A Group	0
Placebo_A Group	0
Low Dose_PLAIN_B Group	1
Medium Dose_PLAIN_B Group	0
High Dose_PLAIN_B Group	2
Low Dose_AS01E_B Group	3
Medium Dose_AS01E_B Group	3
High Dose_AS01E_B Group	7
Low Dose_AS01B_B Group	16
Medium Dose_AS01B_B Group	14

Pain

Group	Value	95% CI
Low Dose_PLAIN_A Group	5
Medium Dose_PLAIN_A Group	7
High Dose_PLAIN_A Group	8
Placebo_A Group	1
Low Dose_PLAIN_B Group	18
Medium Dose_PLAIN_B Group	18
High Dose_PLAIN_B Group	23
Low Dose_AS01E_B Group	34
Medium Dose_AS01E_B Group	48
High Dose_AS01E_B Group	47
Low Dose_AS01B_B Group	58
Medium Dose_AS01B_B Group	56

Swelling

Group	Value	95% CI
Low Dose_PLAIN_A Group	0
Medium Dose_PLAIN_A Group	0
High Dose_PLAIN_A Group	0
Placebo_A Group	0
Low Dose_PLAIN_B Group	0
Medium Dose_PLAIN_B Group	1
High Dose_PLAIN_B Group	2
Low Dose_AS01E_B Group	3
Medium Dose_AS01E_B Group	3
High Dose_AS01E_B Group	6
Low Dose_AS01B_B Group	10
Medium Dose_AS01B_B Group	7

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

Assessed solicited general symptoms include arthralgia, fatigue, fever \[defined as temperature equal to or above 38.0 degrees Celsius (°C)\], gastrointestinal symptoms \[nausea, vomiting, diarrhea and/or abdominal pain\], headache, myalgia and shivering.

Arthralgia

Group	Value	95% CI
Low Dose_PLAIN_A Group	0
Medium Dose_PLAIN_A Group	0
High Dose_PLAIN_A Group	0
Placebo_A Group	0
Low Dose_PLAIN_B Group	7
Medium Dose_PLAIN_B Group	4
High Dose_PLAIN_B Group	0
Low Dose_AS01E_B Group	7
Medium Dose_AS01E_B Group	12
High Dose_AS01E_B Group	6
Low Dose_AS01B_B Group	15
Medium Dose_AS01B_B Group	9

Fatigue

Group	Value	95% CI
Low Dose_PLAIN_A Group	4
Medium Dose_PLAIN_A Group	5
High Dose_PLAIN_A Group	1
Placebo_A Group	6
Low Dose_PLAIN_B Group	22
Medium Dose_PLAIN_B Group	11
High Dose_PLAIN_B Group	24
Low Dose_AS01E_B Group	26
Medium Dose_AS01E_B Group	28
High Dose_AS01E_B Group	21
Low Dose_AS01B_B Group	30
Medium Dose_AS01B_B Group	29

Fever

Group	Value	95% CI
Low Dose_PLAIN_A Group	0
Medium Dose_PLAIN_A Group	0
High Dose_PLAIN_A Group	0
Placebo_A Group	0
Low Dose_PLAIN_B Group	1
Medium Dose_PLAIN_B Group	0
High Dose_PLAIN_B Group	0
Low Dose_AS01E_B Group	1
Medium Dose_AS01E_B Group	3
High Dose_AS01E_B Group	1
Low Dose_AS01B_B Group	3
Medium Dose_AS01B_B Group	3

Gastrointestinal symptoms

Group	Value	95% CI
Low Dose_PLAIN_A Group	1
Medium Dose_PLAIN_A Group	2
High Dose_PLAIN_A Group	1
Placebo_A Group	1
Low Dose_PLAIN_B Group	8
Medium Dose_PLAIN_B Group	8
High Dose_PLAIN_B Group	10
Low Dose_AS01E_B Group	8
Medium Dose_AS01E_B Group	8
High Dose_AS01E_B Group	9
Low Dose_AS01B_B Group	13
Medium Dose_AS01B_B Group	7

Headache

Group	Value	95% CI
Low Dose_PLAIN_A Group	2
Medium Dose_PLAIN_A Group	4
High Dose_PLAIN_A Group	3
Placebo_A Group	2
Low Dose_PLAIN_B Group	8
Medium Dose_PLAIN_B Group	7
High Dose_PLAIN_B Group	13
Low Dose_AS01E_B Group	20
Medium Dose_AS01E_B Group	12
High Dose_AS01E_B Group	17
Low Dose_AS01B_B Group	28
Medium Dose_AS01B_B Group	27

Myalgia

Group	Value	95% CI
Low Dose_PLAIN_A Group	0
Medium Dose_PLAIN_A Group	1
High Dose_PLAIN_A Group	1
Placebo_A Group	0
Low Dose_PLAIN_B Group	4
Medium Dose_PLAIN_B Group	3
High Dose_PLAIN_B Group	1
Low Dose_AS01E_B Group	9
Medium Dose_AS01E_B Group	8
High Dose_AS01E_B Group	6
Low Dose_AS01B_B Group	19
Medium Dose_AS01B_B Group	12

Shivering

Group	Value	95% CI
Low Dose_PLAIN_A Group	0
Medium Dose_PLAIN_A Group	2
High Dose_PLAIN_A Group	0
Placebo_A Group	1
Low Dose_PLAIN_B Group	1
Medium Dose_PLAIN_B Group	1
High Dose_PLAIN_B Group	2
Low Dose_AS01E_B Group	6
Medium Dose_AS01E_B Group	5
High Dose_AS01E_B Group	3
Low Dose_AS01B_B Group	12
Medium Dose_AS01B_B Group	8

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

Arthralgia

Group	Value	95% CI
Low Dose_PLAIN_A Group	0
Medium Dose_PLAIN_A Group	0
High Dose_PLAIN_A Group	0
Placebo_A Group	0
Low Dose_PLAIN_B Group	1
Medium Dose_PLAIN_B Group	4
High Dose_PLAIN_B Group	2
Low Dose_AS01E_B Group	8
Medium Dose_AS01E_B Group	8
High Dose_AS01E_B Group	10
Low Dose_AS01B_B Group	21
Medium Dose_AS01B_B Group	11

Fatigue

Group	Value	95% CI
Low Dose_PLAIN_A Group	3
Medium Dose_PLAIN_A Group	2
High Dose_PLAIN_A Group	4
Placebo_A Group	5
Low Dose_PLAIN_B Group	16
Medium Dose_PLAIN_B Group	11
High Dose_PLAIN_B Group	13
Low Dose_AS01E_B Group	24
Medium Dose_AS01E_B Group	22
High Dose_AS01E_B Group	24
Low Dose_AS01B_B Group	35
Medium Dose_AS01B_B Group	35

Fever

Group	Value	95% CI
Low Dose_PLAIN_A Group	0
Medium Dose_PLAIN_A Group	0
High Dose_PLAIN_A Group	0
Placebo_A Group	0
Low Dose_PLAIN_B Group	0
Medium Dose_PLAIN_B Group	0
High Dose_PLAIN_B Group	0
Low Dose_AS01E_B Group	3
Medium Dose_AS01E_B Group	1
High Dose_AS01E_B Group	1
Low Dose_AS01B_B Group	4
Medium Dose_AS01B_B Group	6

Gastrointestinal symptoms

Group	Value	95% CI
Low Dose_PLAIN_A Group	1
Medium Dose_PLAIN_A Group	1
High Dose_PLAIN_A Group	2
Placebo_A Group	2
Low Dose_PLAIN_B Group	4
Medium Dose_PLAIN_B Group	2
High Dose_PLAIN_B Group	7
Low Dose_AS01E_B Group	7
Medium Dose_AS01E_B Group	5
High Dose_AS01E_B Group	7
Low Dose_AS01B_B Group	11
Medium Dose_AS01B_B Group	7

Headache

Group	Value	95% CI
Low Dose_PLAIN_A Group	2
Medium Dose_PLAIN_A Group	2
High Dose_PLAIN_A Group	3
Placebo_A Group	3
Low Dose_PLAIN_B Group	11
Medium Dose_PLAIN_B Group	9
High Dose_PLAIN_B Group	8
Low Dose_AS01E_B Group	15
Medium Dose_AS01E_B Group	18
High Dose_AS01E_B Group	10
Low Dose_AS01B_B Group	33
Medium Dose_AS01B_B Group	26

Myalgia

Group	Value	95% CI
Low Dose_PLAIN_A Group	0
Medium Dose_PLAIN_A Group	0
High Dose_PLAIN_A Group	0
Placebo_A Group	0
Low Dose_PLAIN_B Group	0
Medium Dose_PLAIN_B Group	2
High Dose_PLAIN_B Group	3
Low Dose_AS01E_B Group	6
Medium Dose_AS01E_B Group	9
High Dose_AS01E_B Group	11
Low Dose_AS01B_B Group	19
Medium Dose_AS01B_B Group	12

Shivering

Group	Value	95% CI
Low Dose_PLAIN_A Group	0
Medium Dose_PLAIN_A Group	0
High Dose_PLAIN_A Group	0
Placebo_A Group	0
Low Dose_PLAIN_B Group	0
Medium Dose_PLAIN_B Group	0
High Dose_PLAIN_B Group	0
Low Dose_AS01E_B Group	9
Medium Dose_AS01E_B Group	3
High Dose_AS01E_B Group	4
Low Dose_AS01B_B Group	14
Medium Dose_AS01B_B Group	12

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

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/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Group	Value	95% CI
Low Dose_PLAIN_A Group	2
Medium Dose_PLAIN_A Group	4
High Dose_PLAIN_A Group	4
Placebo_A Group	6
Low Dose_PLAIN_B Group	34
Medium Dose_PLAIN_B Group	28
High Dose_PLAIN_B Group	30
Low Dose_AS01E_B Group	40
Medium Dose_AS01E_B Group	29
High Dose_AS01E_B Group	36
Low Dose_AS01B_B Group	39
Medium Dose_AS01B_B Group	34

Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose (Part A Groups) Primary · At baseline and at 7 days after the first vaccine dose (Day 8)

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 unkn

ALT-WITHIN-WITHIN

Group	Value	95% CI
Low Dose_PLAIN_A Group	12
Medium Dose_PLAIN_A Group	12
High Dose_PLAIN_A Group	11
Placebo_A Group	12

AST-WITHIN-WITHIN

Group	Value	95% CI
Low Dose_PLAIN_A Group	11
Medium Dose_PLAIN_A Group	12
High Dose_PLAIN_A Group	11
Placebo_A Group	11

AST-ABOVE-WITHIN

Group	Value	95% CI
Low Dose_PLAIN_A Group	1
Medium Dose_PLAIN_A Group	0
High Dose_PLAIN_A Group	0
Placebo_A Group	1

Basophils-WITHIN-WITHIN

Group	Value	95% CI
Low Dose_PLAIN_A Group	12
Medium Dose_PLAIN_A Group	12
High Dose_PLAIN_A Group	11
Placebo_A Group	12

Creatinine-BELOW-BELOW

Group	Value	95% CI
Low Dose_PLAIN_A Group	0
Medium Dose_PLAIN_A Group	0
High Dose_PLAIN_A Group	0
Placebo_A Group	1

Creatinine-BELOW-WITHIN

Group	Value	95% CI
Low Dose_PLAIN_A Group	1
Medium Dose_PLAIN_A Group	2
High Dose_PLAIN_A Group	0
Placebo_A Group	0

Creatinine-WITHIN-WITHIN

Group	Value	95% CI
Low Dose_PLAIN_A Group	11
Medium Dose_PLAIN_A Group	9
High Dose_PLAIN_A Group	11
Placebo_A Group	11

Creatinine-ABOVE-ABOVE

Group	Value	95% CI
Low Dose_PLAIN_A Group	0
Medium Dose_PLAIN_A Group	1
High Dose_PLAIN_A Group	0
Placebo_A Group	0

Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose (Part B Groups) Primary · At baseline and at 7 days after the first vaccine dose (Day 8)

ALT-WITHIN-UNKNOWN

Group	Value	95% CI
Low Dose_PLAIN_B Group	0
Medium Dose_PLAIN_B Group	0
High Dose_PLAIN_B Group	0
Low Dose_AS01E_B Group	1
Medium Dose_AS01E_B Group	0
High Dose_AS01E_B Group	0
Low Dose_AS01B_B Group	0
Medium Dose_AS01B_B Group	0
High Dose_AS01B_B Group	1
Placebo_B Group	1

ALT-WITHIN-WITHIN

Group	Value	95% CI
Low Dose_PLAIN_B Group	99
Medium Dose_PLAIN_B Group	97
High Dose_PLAIN_B Group	98
Low Dose_AS01E_B Group	97
Medium Dose_AS01E_B Group	98
High Dose_AS01E_B Group	100
Low Dose_AS01B_B Group	100
Medium Dose_AS01B_B Group	94
High Dose_AS01B_B Group	98
Placebo_B Group	98

ALT-WITHIN-ABOVE

Group	Value	95% CI
Low Dose_PLAIN_B Group	1
Medium Dose_PLAIN_B Group	0
High Dose_PLAIN_B Group	1
Low Dose_AS01E_B Group	0
Medium Dose_AS01E_B Group	0
High Dose_AS01E_B Group	0
Low Dose_AS01B_B Group	0
Medium Dose_AS01B_B Group	1
High Dose_AS01B_B Group	0
Placebo_B Group	1

ALT-ABOVE-WITHIN

Group	Value	95% CI
Low Dose_PLAIN_B Group	0
Medium Dose_PLAIN_B Group	0
High Dose_PLAIN_B Group	0
Low Dose_AS01E_B Group	0
Medium Dose_AS01E_B Group	2
High Dose_AS01E_B Group	0
Low Dose_AS01B_B Group	0
Medium Dose_AS01B_B Group	2
High Dose_AS01B_B Group	0
Placebo_B Group	0

ALT-ABOVE-ABOVE

Group	Value	95% CI
Low Dose_PLAIN_B Group	1
Medium Dose_PLAIN_B Group	0
High Dose_PLAIN_B Group	0
Low Dose_AS01E_B Group	2
Medium Dose_AS01E_B Group	0
High Dose_AS01E_B Group	0
Low Dose_AS01B_B Group	3
Medium Dose_AS01B_B Group	3
High Dose_AS01B_B Group	2
Placebo_B Group	1

AST-WITHIN-UNKNOWN

Group	Value	95% CI
Low Dose_PLAIN_B Group	0
Medium Dose_PLAIN_B Group	0
High Dose_PLAIN_B Group	0
Low Dose_AS01E_B Group	1
Medium Dose_AS01E_B Group	0
High Dose_AS01E_B Group	1
Low Dose_AS01B_B Group	2
Medium Dose_AS01B_B Group	1
High Dose_AS01B_B Group	1
Placebo_B Group	1

AST-WITHIN-WITHIN

Group	Value	95% CI
Low Dose_PLAIN_B Group	100
Medium Dose_PLAIN_B Group	97
High Dose_PLAIN_B Group	98
Low Dose_AS01E_B Group	98
Medium Dose_AS01E_B Group	99
High Dose_AS01E_B Group	98
Low Dose_AS01B_B Group	97
Medium Dose_AS01B_B Group	97
High Dose_AS01B_B Group	98
Placebo_B Group	99

AST-WITHIN-ABOVE

Group	Value	95% CI
Low Dose_PLAIN_B Group	1
Medium Dose_PLAIN_B Group	0
High Dose_PLAIN_B Group	1
Low Dose_AS01E_B Group	1
Medium Dose_AS01E_B Group	0
High Dose_AS01E_B Group	0
Low Dose_AS01B_B Group	0
Medium Dose_AS01B_B Group	0
High Dose_AS01B_B Group	1
Placebo_B Group	1

Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose (Part A Groups) Primary · At baseline and at 7 days after the second vaccine dose (Day 68)

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 un

ALT-WITHIN-WITHIN

Group	Value	95% CI
Low Dose_PLAIN_A Group	11
Medium Dose_PLAIN_A Group	10
High Dose_PLAIN_A Group	10
Placebo_A Group	12

ALT-WITHIN-ABOVE

Group	Value	95% CI
Low Dose_PLAIN_A Group	1
Medium Dose_PLAIN_A Group	0
High Dose_PLAIN_A Group	0
Placebo_A Group	0

ALT-ABOVE-WITHIN

Group	Value	95% CI
Low Dose_PLAIN_A Group	0
Medium Dose_PLAIN_A Group	0
High Dose_PLAIN_A Group	1
Placebo_A Group	0

AST-WITHIN-WITHIN

Group	Value	95% CI
Low Dose_PLAIN_A Group	10
Medium Dose_PLAIN_A Group	10
High Dose_PLAIN_A Group	11
Placebo_A Group	12

AST-WITHIN-ABOVE

Group	Value	95% CI
Low Dose_PLAIN_A Group	1
Medium Dose_PLAIN_A Group	0
High Dose_PLAIN_A Group	0
Placebo_A Group	0

AST-ABOVE-ABOVE

Group	Value	95% CI
Low Dose_PLAIN_A Group	1
Medium Dose_PLAIN_A Group	0
High Dose_PLAIN_A Group	0
Placebo_A Group	0

Basophils-UNKNOWN-WITHIN

Group	Value	95% CI
Low Dose_PLAIN_A Group	1
Medium Dose_PLAIN_A Group	0
High Dose_PLAIN_A Group	0
Placebo_A Group	0

Basophils-WITHIN-WITHIN

Group	Value	95% CI
Low Dose_PLAIN_A Group	11
Medium Dose_PLAIN_A Group	10
High Dose_PLAIN_A Group	11
Placebo_A Group	12

Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose (Part B Groups) Primary · At baseline and at 7 days after the second vaccine dose (Day 68)

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 un

ALT-UNKNOWN-WITHIN

Group	Value	95% CI
Low Dose_PLAIN_B Group	1
Medium Dose_PLAIN_B Group	0
High Dose_PLAIN_B Group	0
Low Dose_AS01E_B Group	1
Medium Dose_AS01E_B Group	0
High Dose_AS01E_B Group	1
Low Dose_AS01B_B Group	1
Medium Dose_AS01B_B Group	1
High Dose_AS01B_B Group	2
Placebo_B Group	0

ALT-WITHIN-UNKNOWN

Group	Value	95% CI
Low Dose_PLAIN_B Group	0
Medium Dose_PLAIN_B Group	0
High Dose_PLAIN_B Group	0
Low Dose_AS01E_B Group	0
Medium Dose_AS01E_B Group	0
High Dose_AS01E_B Group	0
Low Dose_AS01B_B Group	0
Medium Dose_AS01B_B Group	0
High Dose_AS01B_B Group	0
Placebo_B Group	1

ALT-WITHIN-WITHIN

Group	Value	95% CI
Low Dose_PLAIN_B Group	93
Medium Dose_PLAIN_B Group	94
High Dose_PLAIN_B Group	95
Low Dose_AS01E_B Group	93
Medium Dose_AS01E_B Group	94
High Dose_AS01E_B Group	94
Low Dose_AS01B_B Group	95
Medium Dose_AS01B_B Group	91
High Dose_AS01B_B Group	90
Placebo_B Group	96

ALT-WITHIN-ABOVE

Group	Value	95% CI
Low Dose_PLAIN_B Group	2
Medium Dose_PLAIN_B Group	0
High Dose_PLAIN_B Group	0
Low Dose_AS01E_B Group	0
Medium Dose_AS01E_B Group	2
High Dose_AS01E_B Group	2
Low Dose_AS01B_B Group	0
Medium Dose_AS01B_B Group	2
High Dose_AS01B_B Group	1
Placebo_B Group	0

ALT-ABOVE-WITHIN

Group	Value	95% CI
Low Dose_PLAIN_B Group	1
Medium Dose_PLAIN_B Group	0
High Dose_PLAIN_B Group	0
Low Dose_AS01E_B Group	1
Medium Dose_AS01E_B Group	1
High Dose_AS01E_B Group	0
Low Dose_AS01B_B Group	1
Medium Dose_AS01B_B Group	2
High Dose_AS01B_B Group	2
Placebo_B Group	0

ALT-ABOVE-ABOVE

Group	Value	95% CI
Low Dose_PLAIN_B Group	0
Medium Dose_PLAIN_B Group	0
High Dose_PLAIN_B Group	0
Low Dose_AS01E_B Group	1
Medium Dose_AS01E_B Group	1
High Dose_AS01E_B Group	0
Low Dose_AS01B_B Group	1
Medium Dose_AS01B_B Group	1
High Dose_AS01B_B Group	2
Placebo_B Group	2

AST-UNKNOWN-WITHIN

Group	Value	95% CI
Low Dose_PLAIN_B Group	1
Medium Dose_PLAIN_B Group	0
High Dose_PLAIN_B Group	0
Low Dose_AS01E_B Group	1
Medium Dose_AS01E_B Group	0
High Dose_AS01E_B Group	1
Low Dose_AS01B_B Group	1
Medium Dose_AS01B_B Group	1
High Dose_AS01B_B Group	2
Placebo_B Group	0

AST-WITHIN-UNKNOWN

Group	Value	95% CI
Low Dose_PLAIN_B Group	0
Medium Dose_PLAIN_B Group	0
High Dose_PLAIN_B Group	0
Low Dose_AS01E_B Group	0
Medium Dose_AS01E_B Group	0
High Dose_AS01E_B Group	0
Low Dose_AS01B_B Group	0
Medium Dose_AS01B_B Group	0
High Dose_AS01B_B Group	0
Placebo_B Group	1

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 dose of 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
Low Dose_PLAIN_A Group	1
Medium Dose_PLAIN_A Group	0
High Dose_PLAIN_A Group	0
Placebo_A Group	0
Low Dose_PLAIN_B Group	1
Medium Dose_PLAIN_B Group	1
High Dose_PLAIN_B Group	4
Low Dose_AS01E_B Group	3
Medium Dose_AS01E_B Group	7
High Dose_AS01E_B Group	1
Low Dose_AS01B_B Group	7
Medium Dose_AS01B_B Group	6

General adverse event

Group	Value	95% CI
Low Dose_PLAIN_A Group	1
Medium Dose_PLAIN_A Group	0
High Dose_PLAIN_A Group	0
Placebo_A Group	0
Low Dose_PLAIN_B Group	1
Medium Dose_PLAIN_B Group	1
High Dose_PLAIN_B Group	3
Low Dose_AS01E_B Group	2
Medium Dose_AS01E_B Group	5
High Dose_AS01E_B Group	0
Low Dose_AS01B_B Group	2
Medium Dose_AS01B_B Group	3

Local adverse event

Group	Value	95% CI
Low Dose_PLAIN_A Group	0
Medium Dose_PLAIN_A Group	0
High Dose_PLAIN_A Group	0
Placebo_A Group	0
Low Dose_PLAIN_B Group	0
Medium Dose_PLAIN_B Group	0
High Dose_PLAIN_B Group	2
Low Dose_AS01E_B Group	1
Medium Dose_AS01E_B Group	2
High Dose_AS01E_B Group	1
Low Dose_AS01B_B Group	6
Medium Dose_AS01B_B Group	3

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 dose of vaccination

Any adverse event

Group	Value	95% CI
Low Dose_PLAIN_A Group	1
Medium Dose_PLAIN_A Group	0
High Dose_PLAIN_A Group	0
Placebo_A Group	0
Low Dose_PLAIN_B Group	1
Medium Dose_PLAIN_B Group	0
High Dose_PLAIN_B Group	2
Low Dose_AS01E_B Group	5
Medium Dose_AS01E_B Group	3
High Dose_AS01E_B Group	5
Low Dose_AS01B_B Group	8
Medium Dose_AS01B_B Group	7

General adverse event

Group	Value	95% CI
Low Dose_PLAIN_A Group	1
Medium Dose_PLAIN_A Group	0
High Dose_PLAIN_A Group	0
Placebo_A Group	0
Low Dose_PLAIN_B Group	1
Medium Dose_PLAIN_B Group	0
High Dose_PLAIN_B Group	2
Low Dose_AS01E_B Group	4
Medium Dose_AS01E_B Group	2
High Dose_AS01E_B Group	2
Low Dose_AS01B_B Group	5
Medium Dose_AS01B_B Group	5

Local adverse event

Group	Value	95% CI
Low Dose_PLAIN_A Group	0
Medium Dose_PLAIN_A Group	0
High Dose_PLAIN_A Group	0
Placebo_A Group	0
Low Dose_PLAIN_B Group	0
Medium Dose_PLAIN_B Group	0
High Dose_PLAIN_B Group	0
Low Dose_AS01E_B Group	1
Medium Dose_AS01E_B Group	1
High Dose_AS01E_B Group	3
Low Dose_AS01B_B Group	4
Medium Dose_AS01B_B Group	2

Number of Subjects With Any Serious Adverse Events (SAEs) up to 30 Days After the Second Vaccination Primary · From first vaccination (Day 1) up to 30 days post 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
Low Dose_PLAIN_A Group	0
Medium Dose_PLAIN_A Group	0
High Dose_PLAIN_A Group	0
Placebo_A Group	0
Low Dose_PLAIN_B Group	6
Medium Dose_PLAIN_B Group	0
High Dose_PLAIN_B Group	1
Low Dose_AS01E_B Group	4
Medium Dose_AS01E_B Group	2
High Dose_AS01E_B Group	1
Low Dose_AS01B_B Group	1
Medium Dose_AS01B_B Group	3

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 Day 91 for Part A groups and till Month 14 for Part B groups.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Low Dose_PLAIN_A Group

Serious: 0/12 (0%)

Deaths: 0/12

Medium Dose_PLAIN_A Group

Serious: 0/12 (0%)

Deaths: 0/12

High Dose_PLAIN_A Group

Serious: 0/12 (0%)

Deaths: 0/12

Placebo_A Group

Serious: 0/12 (0%)

Deaths: 0/12

Low Dose_PLAIN_B Group

Serious: 13/101 (13%)

Deaths: 0/101

Medium Dose_PLAIN_B Group

Serious: 3/97 (3%)

Deaths: 1/97

High Dose_PLAIN_B Group

Serious: 5/100 (5%)

Deaths: 1/100

Low Dose_AS01E_B Group

Serious: 8/101 (8%)

Deaths: 0/101

Medium Dose_AS01E_B Group

Serious: 6/101 (6%)

Deaths: 0/101

High Dose_AS01E_B Group

Serious: 11/100 (11%)

Deaths: 0/100

Low Dose_AS01B_B Group

Serious: 9/103 (9%)

Deaths: 1/103

Medium Dose_AS01B_B Group

Serious: 5/100 (5%)

Deaths: 0/100

High Dose_AS01B_B Group

Serious: 9/101 (9%)

Deaths: 1/101

Placebo_B Group

Serious: 9/101 (9%)

Deaths: 0/101

Serious adverse events (82 terms)

Reaction	System	Low Dose_PLAIN_A Group	Medium Dose_PLAIN_A Group	High Dose_PLAIN_A Group	Placebo_A Group	Low Dose_PLAIN_B Group	Medium Dose_PLAIN_B Group	High Dose_PLAIN_B Group	Low Dose_AS01E_B Group	Medium Dose_AS01E_B Group	High Dose_AS01E_B Group	Low Dose_AS01B_B Group	Medium Dose_AS01B_B Group	High Dose_AS01B_B Group	Placebo_B Group
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Iron deficiency anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Arrhythmia	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Atrioventricular block complete	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cardiac arrest	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cardio-respiratory arrest	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cardiomyopathy	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Ventricular extrasystoles	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Ventricular tachycardia	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vertigo	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Chest pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Death	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Biliary colic	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cholecystitis	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cholelithiasis	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (233 terms — click to expand)

Reaction	System	Low Dose_PLAIN_A Group	Medium Dose_PLAIN_A Group	High Dose_PLAIN_A Group	Placebo_A Group	Low Dose_PLAIN_B Group	Medium Dose_PLAIN_B Group	High Dose_PLAIN_B Group	Low Dose_AS01E_B Group	Medium Dose_AS01E_B Group	High Dose_AS01E_B Group	Low Dose_AS01B_B Group	Medium Dose_AS01B_B Group	High Dose_AS01B_B Group	Placebo_B Group
Injection site pain	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastrointestinal disorder	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Injection site swelling	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Influenza like illness	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Injection site pruritus	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Injection site warmth	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Ear pain	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Feeling hot	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Injection site haemorrhage	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Faeces soft	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Tooth abscess	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Back pain, Breast cancer, Prostate cancer, Pulmonary embolism, Iron deficiency anaemia, Acute myocardial infarction, Arrhythmia, Atrial fibrillation.

Data from ClinicalTrials.gov NCT03814590 adverse events section.

Sponsor's own description

The purpose of this study is to assess the safety, reactogenicity and immune responses of two doses of the investigational RSV vaccines (with different formulations), when administered intramuscularly (IM) according to a 0, 2 month schedule, in older adults aged 60 to 80 years. As the investigational vaccines have not yet been tested in humans before, the study will first assess the safety, reactogenicity and immune responses in young adults aged 18 to 40 years. The study will thus be conducted in 2 parts (Part A and Part B).

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
Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F (RSVPreF3) Candidate Vaccine in Older Adults: Phase 1/2 Randomized Clinical Trial.
Leroux-Roels I, Davis MG, Steenackers K, Essink B, et al · · 2023 · cited 95× · PMID 35904987 · DOI 10.1093/infdis/jiac327
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
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
Overview of the respiratory syncytial virus vaccine candidate pipeline in Canada.
Killikelly A, Tunis M, House A, Quach C, et al · · 2020 · cited 17× · PMID 32510521 · DOI 10.14745/ccdr.v46i04a01
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
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
Respiratory Syncytial Virus Vaccines: Analysis of Pre-Marketing Clinical Trials for Immunogenicity in the Population over 50 Years of Age.
Papazisis G, Topalidou X, Gioula G, González PA, et al · · 2024 · cited 8× · PMID 38675736 · DOI 10.3390/vaccines12040353

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Trials by the same sponsor.

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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 NCT03814590 (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: 5 August 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/NCT03814590.

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

NCT03814590

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (82 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Respiratory Syncytial Virus Infections

Other GlaxoSmithKline trials

Verify against primary sources