NCT05960097 is a Phase 2 clinical trial of CV0701 mRNA COVID-19 Vaccine (Low dose) in SARS-CoV-2, sponsored by GlaxoSmithKline.

Who is sponsoring NCT05960097?

NCT05960097 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT05960097?

Interventions in NCT05960097: CV0701 mRNA COVID-19 Vaccine (Low dose), CV0701 mRNA COVID-19 Vaccine (Medium dose), CV0701 mRNA COVID-19 Vaccine (High dose), CV0601 mRNA COVID-19 Vaccine, Control vaccine, CV0801 mRNA COVID-19 Vaccine.

What condition does NCT05960097 study?

NCT05960097 studies SARS-CoV-2, COVID-19.

Is NCT05960097 still recruiting?

NCT05960097 is currently completed. Last updated 23 October 2025.

Are results published for NCT05960097?

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

Last reviewed 2025-10-23 · How we verify

NCT05960097

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

A Study on the Safety and Immune Response of Investigational COVID-19 mRNA Vaccines in Healthy Adults

Completed Phase 2 Results posted Last updated 23 October 2025

What this trial tests

Phase 2 trial testing CV0701 mRNA COVID-19 Vaccine (Low dose) in SARS-CoV-2 in 692 participants. Completed in 30 August 2024.

Timeline

1 August 2023

Primary endpoint
30 August 2024

30 August 2024

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	692
Start date	1 August 2023
Primary completion	30 August 2024
Estimated completion	30 August 2024
Sites	17 locations across United States, Australia

Drugs / interventions tested

CV0701 mRNA COVID-19 Vaccine (Low dose) — full drug profile →
CV0701 mRNA COVID-19 Vaccine (Medium dose) — full drug profile →
CV0701 mRNA COVID-19 Vaccine (High dose)
CV0601 mRNA COVID-19 Vaccine — full drug profile →
Control vaccine — full drug profile →
CV0801 mRNA COVID-19 Vaccine — full drug profile →

Conditions studied

SARS-CoV-2 — all drugs for SARS-CoV-2 →
COVID-19 — all drugs for COVID-19 →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with SARS-CoV-2 or COVID-19. 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.

Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein Secondary · At Day 91 and Day 181

Day 91

Group	Value	95% CI
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)	872.5	686.0 – 1109.7
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)	1181.9	914.8 – 1527.0
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)	1477.7	1160.4 – 1881.8
Part A: CV0601 mRNA COVID-19 Vaccine	1527.8	1196.7 – 1950.4
Part A: Control Vaccine	1155.6	896.6 – 1489.3

Day 181

Group	Value	95% CI
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)	585.0	444.3 – 770.3
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)	797.0	600.2 – 1058.5
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)	977.6	738.2 – 1294.6
Part A: CV0601 mRNA COVID-19 Vaccine	1032.6	777.1 – 1372.2
Part A: Control Vaccine	734.2	546.9 – 985.7

Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein Secondary · At Day 91 and Day 181

Day 91

Group	Value	95% CI
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)	2637.0	2198.6 – 3162.9
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)	3714.0	3058.0 – 4510.8
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)	4284.9	3566.3 – 5148.4
Part A: CV0601 mRNA COVID-19 Vaccine	3952.1	3281.3 – 4760.0
Part A: Control Vaccine	3216.5	2656.1 – 3895.1

Day 181

Group	Value	95% CI
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)	2215.8	1779.5 – 2759.0
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)	2935.4	2342.8 – 3677.9
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)	3319.3	2653.8 – 4151.6
Part A: CV0601 mRNA COVID-19 Vaccine	3243.6	2584.7 – 4070.5
Part A: Control Vaccine	2640.6	2095.6 – 3327.2

Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein Secondary · At Day 29, Day 91 and Day 181

Day 29

Group	Value	95% CI
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)	196.0	155.1 – 247.7
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)	281.5	220.6 – 359.3
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)	335.0	262.4 – 427.6
Part A: CV0601 mRNA COVID-19 Vaccine	404.3	316.8 – 515.9
Part A: Control Vaccine	265.7	209.2 – 337.5

Day 91

Group	Value	95% CI
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)	139.8	108.1 – 180.9
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)	188.6	142.8 – 249.1
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)	259.6	199.3 – 338.2
Part A: CV0601 mRNA COVID-19 Vaccine	259.5	199.6 – 337.2
Part A: Control Vaccine	194.5	148.2 – 255.3

Day 181

Group	Value	95% CI
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)	105.3	78.7 – 140.9
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)	131.1	97.3 – 176.7
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)	170.2	125.7 – 230.5
Part A: CV0601 mRNA COVID-19 Vaccine	180.2	133.5 – 243.1
Part A: Control Vaccine	117.2	85.9 – 159.7

Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein Secondary · At Day 29 compared to baseline (Day 1)

Seroresponse is defined as post-booster titer greater than or equal to (≥) 4 times the lower limit of quantification (LLOQ) when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.

Group	Value	95% CI
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)	38.5	27.66 – 50.17
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)	50.0	38.14 – 61.86
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)	50.7	38.86 – 62.42
Part A: CV0601 mRNA COVID-19 Vaccine	51.4	39.44 – 63.15
Part A: Control Vaccine	48.1	36.71 – 59.64

Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein Secondary · At Day 29 compared to baseline (Day 1)

Seroresponse is defined as post-booster titer ≥ 4 times the lower limit of quantification (LLOQ) when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.

Group	Value	95% CI
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)	17.9	10.17 – 28.28
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)	25.7	16.22 – 37.16
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)	29.3	19.38 – 40.98
Part A: CV0601 mRNA COVID-19 Vaccine	25.7	16.22 – 37.16
Part A: Control Vaccine	35.0	24.67 – 46.48

Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein Secondary · At Day 29 compared to baseline (Day 1)

Seroresponse is defined as post-booster titer ≥ 4 times the LLOQ when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.

Group	Value	95% CI
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)	39.7	28.83 – 51.46
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)	43.8	32.24 – 55.95
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)	55.4	43.39 – 66.98
Part A: CV0601 mRNA COVID-19 Vaccine	47.3	35.57 – 59.25
Part A: Control Vaccine	47.5	36.21 – 58.98

Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein Secondary · At Day 29, Day 91 and Day 181 compared to baseline (Day 1)

GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.

Day 29

Group	Value	95% CI
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)	2.72	2.17 – 3.42
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)	3.84	3.03 – 4.87
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)	4.56	3.62 – 5.75
Part A: CV0601 mRNA COVID-19 Vaccine	4.77	3.76 – 6.04
Part A: Control Vaccine	3.71	2.94 – 4.68

Day 91

Group	Value	95% CI
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)	1.69	1.33 – 2.15
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)	2.29	1.77 – 2.95
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)	2.86	2.24 – 3.64
Part A: CV0601 mRNA COVID-19 Vaccine	2.95	2.31 – 3.77
Part A: Control Vaccine	2.23	1.73 – 2.88

Day 181

Group	Value	95% CI
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)	0.96	0.73 – 1.27
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)	1.31	0.99 – 1.74
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)	1.61	1.21 – 2.13
Part A: CV0601 mRNA COVID-19 Vaccine	1.70	1.28 – 2.26
Part A: Control Vaccine	1.21	0.90 – 1.62

Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein Secondary · At Day 29, Day 91 and Day 181 compared to baseline (Day 1)

GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.

Day 29

Group	Value	95% CI
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)	2.14	1.79 – 2.55
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)	2.68	2.23 – 3.23
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)	3.03	2.52 – 3.63
Part A: CV0601 mRNA COVID-19 Vaccine	3.02	2.51 – 3.63
Part A: Control Vaccine	2.79	2.33 – 3.34

Day 91

Group	Value	95% CI
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)	1.41	1.17 – 1.69
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)	1.98	1.63 – 2.41
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)	2.28	1.90 – 2.75
Part A: CV0601 mRNA COVID-19 Vaccine	2.11	1.75 – 2.54
Part A: Control Vaccine	1.72	1.42 – 2.08

Day 181

Group	Value	95% CI
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)	1.07	0.86 – 1.34
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)	1.42	1.14 – 1.78
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)	1.61	1.29 – 2.01
Part A: CV0601 mRNA COVID-19 Vaccine	1.57	1.25 – 1.97
Part A: Control Vaccine	1.28	1.02 – 1.61

Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein Secondary · At Day 29, Day 91 and Day 181 compared to baseline (Day 1)

GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.

Day 29

Group	Value	95% CI
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)	2.66	2.11 – 3.36
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)	3.82	3.00 – 4.88
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)	4.55	3.56 – 5.81
Part A: CV0601 mRNA COVID-19 Vaccine	5.49	4.30 – 7.00
Part A: Control Vaccine	3.61	2.84 – 4.58

Day 91

Group	Value	95% CI
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)	1.78	1.37 – 2.30
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)	2.40	1.82 – 3.17
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)	3.30	2.53 – 4.30
Part A: CV0601 mRNA COVID-19 Vaccine	3.30	2.54 – 4.29
Part A: Control Vaccine	2.47	1.88 – 3.25

Day 181

Group	Value	95% CI
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)	1.16	0.86 – 1.55
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)	1.44	1.07 – 1.94
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)	1.87	1.38 – 2.53
Part A: CV0601 mRNA COVID-19 Vaccine	1.98	1.47 – 2.67
Part A: Control Vaccine	1.29	0.94 – 1.76

Part A: Geometric Mean Titer (GMT) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein Primary · At Day 29

Group	Value	95% CI
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)	1266.7	1008.1 – 1591.7
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)	1786.9	1409.1 – 2265.9
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)	2122.1	1681.9 – 2677.4
Part A: CV0601 mRNA COVID-19 Vaccine	2218.6	1751.4 – 2810.5
Part A: Control Vaccine	1725.5	1367.6 – 2177.0

Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein Primary · At Day 29

Group	Value	95% CI
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)	3725.0	3116.4 – 4452.5
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)	4680.6	3886.5 – 5637.0
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)	5275.7	4397.6 – 6329.1
Part A: CV0601 mRNA COVID-19 Vaccine	5261.2	4368.3 – 6336.5
Part A: Control Vaccine	4863.4	4058.1 – 5828.5

Part B: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein Primary · At Day 29

Group	Value	95% CI
Part B: CV0801 mRNA COVID-19 Vaccine (Baseline-control Storage Condition)	5658.8	4762.8 – 6723.4
Part B: CV0801 mRNA COVID-19 Vaccine (Intermediate Storage Condition)	4889.4	4097.4 – 5834.5
Part B: CV0801 mRNA COVID-19 Vaccine (Maximum Storage Condition)	4629.7	3892.7 – 5506.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)

Serious: 3/87 (3%)

Deaths: 0/87

Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)

Serious: 0/84 (0%)

Deaths: 0/84

Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)

Serious: 3/84 (4%)

Deaths: 0/84

Part A: CV0601 mRNA COVID-19 Vaccine

Serious: 1/85 (1%)

Deaths: 0/85

Part A: Control Vaccine

Serious: 3/85 (4%)

Deaths: 0/85

Part B: CV0801 mRNA COVID-19 Vaccine (Maximum Storage Condition)

Serious: 2/86 (2%)

Deaths: 0/86

Part B: CV0801 mRNA COVID-19 Vaccine (Intermediate Storage Condition)

Serious: 2/87 (2%)

Deaths: 0/87

Part B: CV0801 mRNA COVID-19 Vaccine (Baseline-control Storage Condition)

Serious: 4/88 (5%)

Deaths: 0/88

Serious adverse events (20 terms)

Reaction	System	Part A: CV0701 mRNA COVID-…	Part A: CV0701 mRNA COVID-…	Part A: CV0701 mRNA COVID-…	Part A: CV0601 mRNA COVID-…	Part A: Control Vaccine	Part B: CV0801 mRNA COVID-…	Part B: CV0801 mRNA COVID-…	Part B: CV0801 mRNA COVID-…
Coronary artery disease	Cardiac disorders	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Biliary colic	Hepatobiliary disorders	—	—	—	—	—	—	—	—
Hepatic cyst	Hepatobiliary disorders	—	—	—	—	—	—	—	—
Abscess limb	Infections and infestations	—	—	—	—	—	—	—	—
Endocarditis	Infections and infestations	—	—	—	—	—	—	—	—
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	—	—	—	—	—	—	—	—
Ophthalmic herpes simplex	Infections and infestations	—	—	—	—	—	—	—	—
Rhinovirus infection	Infections and infestations	—	—	—	—	—	—	—	—
Joint dislocation	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Road traffic accident	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—	—	—	—	—
Mixed anxiety and depressive disorder	Psychiatric disorders	—	—	—	—	—	—	—	—
Suicidal ideation	Psychiatric disorders	—	—	—	—	—	—	—	—
Nephrolithiasis	Renal and urinary disorders	—	—	—	—	—	—	—	—
Ureterolithiasis	Renal and urinary disorders	—	—	—	—	—	—	—	—
Endometrial hyperplasia with cellular atypia	Reproductive system and breast disorders	—	—	—	—	—	—	—	—

Other adverse events (128 terms — click to expand)

Reaction	System	Part A: CV0701 mRNA COVID-…	Part A: CV0701 mRNA COVID-…	Part A: CV0701 mRNA COVID-…	Part A: CV0601 mRNA COVID-…	Part A: Control Vaccine	Part B: CV0801 mRNA COVID-…	Part B: CV0801 mRNA COVID-…	Part B: CV0801 mRNA COVID-…
Injection site pain	General disorders	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Fever	General disorders	—	—	—	—	—	—	—	—
Injection site erythema	General disorders	—	—	—	—	—	—	—	—
Injection site swelling	General disorders	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Seasonal allergy	Immune system disorders	—	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Iron deficiency	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—
Depression	Psychiatric disorders	—	—	—	—	—	—	—	—
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—
Iron deficiency anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Palpitations	Cardiac disorders	—	—	—	—	—	—	—	—
Ventricular extrasystoles	Cardiac disorders	—	—	—	—	—	—	—	—
Conjunctivitis allergic	Eye disorders	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Frequent bowel movements	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Irritable bowel syndrome	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Chest discomfort	General disorders	—	—	—	—	—	—	—	—
Injection site pruritus	General disorders	—	—	—	—	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—	—	—	—	—

Most-reported serious reactions: Coronary artery disease, Abdominal pain, Gastrooesophageal reflux disease, Biliary colic, Hepatic cyst, Abscess limb, Endocarditis, Infective exacerbation of chronic obstructive airways disease.

Data from ClinicalTrials.gov NCT05960097 adverse events section.

Sponsor's own description

The purpose of Part A of this study is to assess the immune response and safety of a booster dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the investigational vaccines to control vaccine. The purpose of Part B of this study is to assess the immune response and safety of a booster dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the investigational vaccine under three different storage conditions.

Publications & conference data

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

Clinical development of therapeutic mRNA applications.
Żak MM, Zangi L. · · 2025 · cited 28× · PMID 40143545 · DOI 10.1016/j.ymthe.2025.03.034
Advancing mRNA vaccines for infectious diseases: key components, innovations, and clinical progress.
Li S, Zheng L, Zhong J, Gao X. · · 2025 · cited 8× · PMID 40321006 · DOI 10.1042/ebc20253009
Engineering Lipid Nanoparticles for mRNA Immunotherapy.
Zwolsman R, Darwish YB, Kluza E, van der Meel R. · · 2025 · cited 8× · PMID 40195623 · DOI 10.1002/wnan.70007
Bioresponsive engineered nanoparticles for immunomodulation.
Hegde M, Mishra A, Banerjee R, Bintee B, et al · · 2025 · cited 4× · PMID 41162977 · DOI 10.1186/s12916-025-04305-6
Safety and immunogenicity of a modified mRNA-lipid nanoparticle vaccine candidate against COVID-19: Results from a phase 1, dose-escalation study.
Essink BJ, Shapiro C, Isidro MGD, Bradley P, et al · · 2024 · cited 3× · PMID 39422261 · DOI 10.1080/21645515.2024.2408863

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Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05960097 (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: 23 October 2025

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/NCT05960097.

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NCT05960097

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 (20 terms)

Sponsor's own description

Publications & conference data

Related trials

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Other GlaxoSmithKline trials

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