A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and Above
CompletedPhase 2Results postedLast updated 8 August 2025
What this trial tests
Phase 2 trial testing RSVPreF3 OA Investigational Vaccine in Respiratory Syncytial Virus Infections in 386 participants. Completed in 16 May 2025.
18 and older, 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.
RSV-A Serum Neutralizing Titers Expressed As Mean Geometric Increase (MGI) Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 GroupPrimary· At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days)
MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-A post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3).
Group
Value
95% CI
RSV_IC_2 Group
1.34
1.20 – 1.48
RSV-B Serum Neutralizing Titers Expressed As MGI Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 GroupPrimary· At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days)
MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-B post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3).
Group
Value
95% CI
RSV_IC_2 Group
1.26
1.14 – 1.40
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA GroupsSecondary· At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 in a subset of participants (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days)
Neutralizing titers were calculated as GMT and expressed in titers (Estimated Dilution 60 \[ED60\]).
RSV-A , Visit 1
Group
Value
95% CI
RSV_IC_1 Group
807.0
700.9 – 929.2
RSV_IC_2 Group
814.1
701.3 – 945.1
RSV_HA Group
889.0
781.9 – 1010.6
RSV-A , Visit 2
Group
Value
95% CI
RSV_IC_1 Group
1775.8
1201.0 – 2625.6
RSV_IC_2 Group
2031.1
1283.6 – 3213.9
RSV_HA Group
6716.8
4907.6 – 9193.0
RSV-A , Visit 3
Group
Value
95% CI
RSV_IC_1 Group
3990.8
3219.4 – 4947.0
RSV_IC_2 Group
4174.0
3230.7 – 5392.6
RSV_HA Group
6822.5
5926.2 – 7854.4
RSV-A , Visit 4
Group
Value
95% CI
RSV_IC_1 Group
4184.7
3360.1 – 5211.7
RSV_IC_2 Group
5377.9
4265.4 – 6780.6
RSV_HA Group
5707.0
4853.6 – 6710.3
RSV-B, Visit 1
Group
Value
95% CI
RSV_IC_1 Group
864.2
727.8 – 1026.2
RSV_IC_2 Group
892.9
754.1 – 1057.3
RSV_HA Group
1027.3
889.6 – 1186.3
RSV-B, Visit 2
Group
Value
95% CI
RSV_IC_1 Group
2325.3
1592.9 – 3394.5
RSV_IC_2 Group
2603.1
1714.9 – 3951.3
RSV_HA Group
8113.6
5699.9 – 11549.5
RSV-B, Visit 3
Group
Value
95% CI
RSV_IC_1 Group
5002.9
3901.7 – 6414.8
RSV_IC_2 Group
4834.7
3736.6 – 6255.6
RSV_HA Group
9140.5
7805.3 – 10704.1
RSV-B, Visit 4
Group
Value
95% CI
RSV_IC_1 Group
4461.7
3519.0 – 5657.0
RSV_IC_2 Group
5820.8
4658.2 – 7273.5
RSV_HA Group
6281.6
5377.6 – 7337.7
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC GroupsSecondary· At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days)
Group GMT was assessed for RSV\_HA group over pooled RSV\_IC group (combined RSV\_IC\_1 and RSV\_IC\_2 groups). The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_HA and Pooled RSV\_IC groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Visit 2
Group
Value
95% CI
RSV_HA Group
6689.9
4639.3 – 9646.7
Pooled RSV_IC Group
1902.8
1479.6 – 2446.9
Visit 3
Group
Value
95% CI
RSV_HA Group
6653.8
5503.5 – 8044.6
Pooled RSV_IC Group
4113.0
3595.5 – 4705.0
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 GroupsSecondary· At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)
Group GMT of RSV\_IC\_2 over RSV\_IC\_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer and the SOT type as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_1 and RSV\_IC\_2 groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Group
Value
95% CI
RSV_IC_1 Group
4041.9
3254.8 – 5019.3
RSV_IC_2 Group
5098.4
4088.8 – 6357.3
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA GroupsSecondary· At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)
Group GMT of RSV\_HA over RSV\_IC\_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_1 and RSV\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Group
Value
95% CI
RSV_IC_1 Group
4244.8
3551.8 – 5073.0
RSV_HA Group
5541.6
4622.0 – 6644.2
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA GroupsSecondary· At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)
Group GMT of RSV\_HA over RSV\_IC\_2 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_2 and RSV\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Group
Value
95% CI
RSV_IC_2 Group
5505.3
4627.0 – 6550.3
RSV_HA Group
5615.7
4719.8 – 6681.6
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC GroupsSecondary· At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days)
Group GMT was assessed for RSV\_HA group over pooled RSV\_IC group (combined RSV\_IC\_1 and RSV\_IC\_2 groups). The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_HA and Pooled RSV\_IC groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Visit 2
Group
Value
95% CI
RSV_HA Group
8238.7
5972.9 – 11364.1
Pooled RSV_IC Group
2442.6
1958.3 – 3046.7
Visit 3
Group
Value
95% CI
RSV_HA Group
8545.5
7031.3 – 10385.8
Pooled RSV_IC Group
5106.9
4448.4 – 5863.0
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 GroupsSecondary· At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)
Group GMT ratio of RSV\_IC\_2 over RSV\_IC\_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer and the SOT type as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_1 and RSV\_IC\_2 groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Group
Value
95% CI
RSV_IC_1 Group
4333.3
3510.0 – 5349.8
RSV_IC_2 Group
5550.5
4478.3 – 6879.4
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA GroupsSecondary· At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)
Group GMT of RSV\_HA over RSV\_IC\_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_1 and RSV\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Group
Value
95% CI
RSV_IC_1 Group
4632.9
3890.8 – 5516.6
RSV_HA Group
5973.5
5000.9 – 7135.4
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA GroupsSecondary· At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)
Group GMT of RSV\_HA over RSV\_IC\_2 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV\_IC\_2 and RSV\_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.
Group
Value
95% CI
RSV_IC_2 Group
6090.6
5184.6 – 7155.0
RSV_HA Group
6123.0
5212.1 – 7193.0
RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGISecondary· At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days), each compared to Visit 1 (Day 1)
MGI was assessed at Visit 2 (in a subset of participants) over Visit 1 and Visit 3 over Visit 1 in RSV\_HA and pooled RSV\_IC (combined RSV\_IC\_1 and RSV\_IC\_2 groups), and at Visit 4 over Visit 1 in RSV\_IC\_1, RSV\_IC\_2, RSV\_HA groups.
RSV-A, Visit 2
Group
Value
95% CI
RSV_IC_1 Group
2.14
1.44 – 3.18
RSV_IC_2 Group
2.20
1.45 – 3.34
RSV_HA Group
7.59
5.44 – 10.58
Pooled RSV_IC Group
2.17
1.64 – 2.87
RSV-A, Visit 3
Group
Value
95% CI
RSV_IC_1 Group
4.92
3.95 – 6.12
RSV_IC_2 Group
5.01
4.00 – 6.27
RSV_HA Group
7.82
6.74 – 9.06
Pooled RSV_IC Group
4.96
4.24 – 5.80
RSV-A, Visit 4
Group
Value
95% CI
RSV_IC_1 Group
5.29
4.24 – 6.60
RSV_IC_2 Group
6.53
5.32 – 8.01
RSV_HA Group
6.55
5.60 – 7.6
RSV-B, Visit 2
Group
Value
95% CI
RSV_IC_1 Group
2.51
1.78 – 3.55
RSV_IC_2 Group
2.54
1.75 – 3.67
RSV_HA Group
8.59
6.59 – 11.20
Pooled RSV_IC Group
2.53
1.98 – 3.23
RSV-B, Visit 3
Group
Value
95% CI
RSV_IC_1 Group
5.72
4.53 – 7.21
RSV_IC_2 Group
5.34
4.25 – 6.72
RSV_HA Group
8.80
7.67 – 10.11
Pooled RSV_IC Group
5.53
4.71 – 6.51
RSV-B, Visit 4
Group
Value
95% CI
RSV_IC_1 Group
5.22
4.20 – 6.49
RSV_IC_2 Group
6.52
5.34 – 7.97
RSV_HA Group
6.35
5.50 – 7.33
Adverse events — posted to ClinicalTrials.gov
Time frame: Solicited AEs: within 7 days post each dose administration, and unsolicited AEs: within 30 days post each dose administration, where doses were administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1(Day 1) + 30-60 days] for RSV_IC_2 group). SAEs, related SAEs, fatal SAEs, pIMDs, related pIMDs and AESIs specific for renal/lung transplant: Visit 1 (Day 1) to Visit 4 (Visit 3 + 30-42 days)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
RSV_IC_1 Group
Serious: 12/131 (9%)
Deaths: 0/131
RSV_IC_2 Group
Serious: 18/130 (14%)
Deaths: 2/130
RSV_HA Group
Serious: 3/125 (2%)
Deaths: 0/125
Serious adverse events (36 terms)
Reaction
System
RSV_IC_1 Group
RSV_IC_2 Group
RSV_HA Group
Pneumonia
Infections and infestations
—
—
—
Sepsis
Infections and infestations
—
—
—
Gastroenteritis
Infections and infestations
—
—
—
Acute kidney injury
Renal and urinary disorders
—
—
—
Pyrexia
General disorders
—
—
—
COVID-19
Infections and infestations
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
Aspergillus infection
Infections and infestations
—
—
—
Urosepsis
Infections and infestations
—
—
—
Escherichia bacteraemia
Infections and infestations
—
—
—
Gangrene
Infections and infestations
—
—
—
Bursitis infective
Infections and infestations
—
—
—
Gastroenteritis Escherichia coli
Infections and infestations
—
—
—
Influenza
Infections and infestations
—
—
—
Oesophageal candidiasis
Infections and infestations
—
—
—
Colitis
Gastrointestinal disorders
—
—
—
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Oropharyngeal squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Myelodysplastic syndrome with excess blasts
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Renal impairment
Renal and urinary disorders
—
—
—
Urinary retention
Renal and urinary disorders
—
—
—
Chest pain
General disorders
—
—
—
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
—
Other adverse events (113 terms — click to expand)
The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a second dose of the vaccine increases the immune response.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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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: 8 August 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/NCT05921903.