Trial Outcomes & Findings for 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 (NCT NCT05921903)

NCT ID: NCT05921903

Last Updated: 2025-08-08

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

386 participants

Primary outcome timeframe

At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days)

Results posted on

2025-08-08

Participant Flow

Participants from 48 study sites were enrolled in the study.

All participants enrolled were randomized to the Exposed set and started the study. Analysis presented includes data up to Primary Completion. Additional results will be provided within one year of study completion.

Participant milestones

Participant milestones
Measure	RSV_IC_1 Group Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	RSV_IC_2 Group IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_HA Group Healthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
Overall Study STARTED	131	130	125
Overall Study COMPLETED	2	0	12
Overall Study NOT COMPLETED	129	130	113

Reasons for withdrawal

Reasons for withdrawal
Measure	RSV_IC_1 Group Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	RSV_IC_2 Group IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_HA Group Healthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
Overall Study Unsolicited non-SAE	0	1	0
Overall Study SAEs/pIMDs/AESIs specific to SOT	0	3	1
Overall Study Ongoing at the time of Primary Completion Analysis	129	126	112

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RSV_IC_1 Group n=131 Participants Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	RSV_IC_2 Group n=130 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_HA Group n=125 Participants Healthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	Total n=386 Participants Total of all reporting groups
Age, Continuous	61.9 YEARS STANDARD_DEVIATION 9.3 • n=5 Participants	61.4 YEARS STANDARD_DEVIATION 8.4 • n=7 Participants	63.8 YEARS STANDARD_DEVIATION 8.2 • n=5 Participants	62.4 YEARS STANDARD_DEVIATION 8.7 • n=4 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	50 Participants n=7 Participants	66 Participants n=5 Participants	170 Participants n=4 Participants
Sex: Female, Male Male	77 Participants n=5 Participants	80 Participants n=7 Participants	59 Participants n=5 Participants	216 Participants n=4 Participants
Race/Ethnicity, Customized White	89 Participants n=5 Participants	79 Participants n=7 Participants	95 Participants n=5 Participants	263 Participants n=4 Participants
Race/Ethnicity, Customized All Other Races	42 Participants n=5 Participants	51 Participants n=7 Participants	30 Participants n=5 Participants	123 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days)

Population: Analysis was performed on the Per protocol Set (PPS) for humoral immunogenicity, which included all participants who received the study intervention administration as per protocol, had immunogenicity results pre and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity, without prohibited concomitant medication/vaccination. Only participants with data available at the specified timepoints were included in the analysis.

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).

Outcome measures

Outcome measures
Measure	RSV_IC_2 Group n=111 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_IC_2 Group IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_HA Group Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	Pooled RSV_IC Group IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
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 Group	1.34 Ratio Interval 1.2 to 1.48	—	—	—

PRIMARY outcome

Timeframe: At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days)

Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

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).

Outcome measures

Outcome measures
Measure	RSV_IC_2 Group n=111 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_IC_2 Group IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_HA Group Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	Pooled RSV_IC Group IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
RSV-B Serum Neutralizing Titers Expressed As MGI Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group	1.26 Ratio Interval 1.14 to 1.4	—	—	—

SECONDARY outcome

Timeframe: 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)

Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.

Neutralizing titers were calculated as GMT and expressed in titers (Estimated Dilution 60 \[ED60\]).

Outcome measures

Outcome measures
Measure	RSV_IC_2 Group n=123 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_IC_2 Group n=123 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_HA Group n=125 Participants Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	Pooled RSV_IC Group IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups RSV-A , Visit 1	807.0 Titers (ED60) Interval 700.9 to 929.2	814.1 Titers (ED60) Interval 701.3 to 945.1	889.0 Titers (ED60) Interval 781.9 to 1010.6	—
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups RSV-A , Visit 2	1775.8 Titers (ED60) Interval 1201.0 to 2625.6	2031.1 Titers (ED60) Interval 1283.6 to 3213.9	6716.8 Titers (ED60) Interval 4907.6 to 9193.0	—
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups RSV-A , Visit 3	3990.8 Titers (ED60) Interval 3219.4 to 4947.0	4174.0 Titers (ED60) Interval 3230.7 to 5392.6	6822.5 Titers (ED60) Interval 5926.2 to 7854.4	—
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups RSV-A , Visit 4	4184.7 Titers (ED60) Interval 3360.1 to 5211.7	5377.9 Titers (ED60) Interval 4265.4 to 6780.6	5707.0 Titers (ED60) Interval 4853.6 to 6710.3	—
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups RSV-B, Visit 1	864.2 Titers (ED60) Interval 727.8 to 1026.2	892.9 Titers (ED60) Interval 754.1 to 1057.3	1027.3 Titers (ED60) Interval 889.6 to 1186.3	—
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups RSV-B, Visit 2	2325.3 Titers (ED60) Interval 1592.9 to 3394.5	2603.1 Titers (ED60) Interval 1714.9 to 3951.3	8113.6 Titers (ED60) Interval 5699.9 to 11549.5	—
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups RSV-B, Visit 3	5002.9 Titers (ED60) Interval 3901.7 to 6414.8	4834.7 Titers (ED60) Interval 3736.6 to 6255.6	9140.5 Titers (ED60) Interval 7805.3 to 10704.1	—
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups RSV-B, Visit 4	4461.7 Titers (ED60) Interval 3519.0 to 5657.0	5820.8 Titers (ED60) Interval 4658.2 to 7273.5	6281.6 Titers (ED60) Interval 5377.6 to 7337.7	—

SECONDARY outcome

Timeframe: At Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)

Neutralizing titers were calculated as GMT and expressed in titers (ED60).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days)

Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.

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.

Outcome measures

Outcome measures
Measure	RSV_IC_2 Group n=118 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_IC_2 Group n=235 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_HA Group Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	Pooled RSV_IC Group IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups Visit 2	6689.9 Titers (ED60) Interval 4639.3 to 9646.7	1902.8 Titers (ED60) Interval 1479.6 to 2446.9	—	—
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups Visit 3	6653.8 Titers (ED60) Interval 5503.5 to 8044.6	4113.0 Titers (ED60) Interval 3595.5 to 4705.0	—	—

SECONDARY outcome

Timeframe: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)

Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.

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.

Outcome measures

Outcome measures
Measure	RSV_IC_2 Group n=114 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_IC_2 Group n=110 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_HA Group Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	Pooled RSV_IC Group IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups	4041.9 Titers (ED60) Interval 3254.8 to 5019.3	5098.4 Titers (ED60) Interval 4088.8 to 6357.3	—	—

SECONDARY outcome

Timeframe: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)

Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.

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.

Outcome measures

Outcome measures
Measure	RSV_IC_2 Group n=114 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_IC_2 Group n=110 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_HA Group Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	Pooled RSV_IC Group IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups	4244.8 Titers (ED60) Interval 3551.8 to 5073.0	5541.6 Titers (ED60) Interval 4622.0 to 6644.2	—	—

SECONDARY outcome

Timeframe: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)

Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.

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.

Outcome measures

Outcome measures
Measure	RSV_IC_2 Group n=110 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_IC_2 Group n=110 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_HA Group Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	Pooled RSV_IC Group IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups	5505.3 Titers (ED60) Interval 4627.0 to 6550.3	5615.7 Titers (ED60) Interval 4719.8 to 6681.6	—	—

SECONDARY outcome

Timeframe: At Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days)

Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.

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.

Outcome measures

Outcome measures
Measure	RSV_IC_2 Group n=118 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_IC_2 Group n=235 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_HA Group Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	Pooled RSV_IC Group IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups Visit 2	8238.7 Titers (ED60) Interval 5972.9 to 11364.1	2442.6 Titers (ED60) Interval 1958.3 to 3046.7	—	—
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups Visit 3	8545.5 Titers (ED60) Interval 7031.3 to 10385.8	5106.9 Titers (ED60) Interval 4448.4 to 5863.0	—	—

SECONDARY outcome

Timeframe: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)

Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.

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.

Outcome measures

Outcome measures
Measure	RSV_IC_2 Group n=114 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_IC_2 Group n=110 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_HA Group Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	Pooled RSV_IC Group IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups	4333.3 Titers (ED60) Interval 3510.0 to 5349.8	5550.5 Titers (ED60) Interval 4478.3 to 6879.4	—	—

SECONDARY outcome

Timeframe: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)

Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.

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.

Outcome measures

Outcome measures
Measure	RSV_IC_2 Group n=114 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_IC_2 Group n=110 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_HA Group Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	Pooled RSV_IC Group IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups	4632.9 Titers (ED60) Interval 3890.8 to 5516.6	5973.5 Titers (ED60) Interval 5000.9 to 7135.4	—	—

SECONDARY outcome

Timeframe: At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)

Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.

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.

Outcome measures

Outcome measures
Measure	RSV_IC_2 Group n=110 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_IC_2 Group n=110 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_HA Group Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	Pooled RSV_IC Group IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups	6090.6 Titers (ED60) Interval 5184.6 to 7155.0	6123.0 Titers (ED60) Interval 5212.1 to 7193.0	—	—

SECONDARY outcome

Timeframe: At Visit 5 (last dose +180-210 days) and Visit 6 (last dose + 350-380 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

Population: Analysis was performed on PPS for humoral immunogenicity. Only participants with data available for the specified groups at the specified timepoints were included in this analysis.

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.

Outcome measures

Outcome measures
Measure	RSV_IC_2 Group n=122 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_IC_2 Group n=113 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_HA Group n=118 Participants Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	Pooled RSV_IC Group n=235 Participants IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI RSV-A, Visit 2	2.14 Ratio Interval 1.44 to 3.18	2.20 Ratio Interval 1.45 to 3.34	7.59 Ratio Interval 5.44 to 10.58	2.17 Ratio Interval 1.64 to 2.87
RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI RSV-A, Visit 3	4.92 Ratio Interval 3.95 to 6.12	5.01 Ratio Interval 4.0 to 6.27	7.82 Ratio Interval 6.74 to 9.06	4.96 Ratio Interval 4.24 to 5.8
RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI RSV-A, Visit 4	5.29 Ratio Interval 4.24 to 6.6	6.53 Ratio Interval 5.32 to 8.01	6.55 Ratio Interval 5.6 to 7.6	—
RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI RSV-B, Visit 2	2.51 Ratio Interval 1.78 to 3.55	2.54 Ratio Interval 1.75 to 3.67	8.59 Ratio Interval 6.59 to 11.2	2.53 Ratio Interval 1.98 to 3.23
RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI RSV-B, Visit 3	5.72 Ratio Interval 4.53 to 7.21	5.34 Ratio Interval 4.25 to 6.72	8.80 Ratio Interval 7.67 to 10.11	5.53 Ratio Interval 4.71 to 6.51
RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI RSV-B, Visit 4	5.22 Ratio Interval 4.2 to 6.49	6.52 Ratio Interval 5.34 to 7.97	6.35 Ratio Interval 5.5 to 7.33	—

SECONDARY outcome

Timeframe: At Visit 5 (last dose +180-210 days) and Visit 6 (last dose + 350-380 days), each compared with Visit 1 (Day 1)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days)

Population: Analysis was performed on the PPS for cell mediated immunity (CMI), which included all participants who received the study intervention administration as per protocol, had cell mediated immunogenicity results pre and post-dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity, without prohibited concomitant medication/vaccination. Only participants with data available for CD4+ T cells at the specified timepoints were included in analysis.

CMI response is expressed as group geometric mean of the frequency of RSVPreF3-specific cluster of differentiation CD4+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-alpha, IFN-gamma, IL- 13 and IL-17. The CMI is measured in a subgroup consisting of participants with renal and lung SOT (from RSV\_IC\_1 and RSV\_IC\_2 groups) and healthy participants (from RSV\_HA group).

Outcome measures

Outcome measures
Measure	RSV_IC_2 Group n=24 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_IC_2 Group n=28 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_HA Group n=31 Participants Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	Pooled RSV_IC Group IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells Visit 1	86.8 Specific CD4+ Tcells/million CD4+ Tcells Standard Deviation 1.0	110.3 Specific CD4+ Tcells/million CD4+ Tcells Standard Deviation 0.9	107.8 Specific CD4+ Tcells/million CD4+ Tcells Standard Deviation 0.9	—
Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells Visit 2	2932.2 Specific CD4+ Tcells/million CD4+ Tcells Standard Deviation 0.6	3704.3 Specific CD4+ Tcells/million CD4+ Tcells Standard Deviation 0.5	2959.8 Specific CD4+ Tcells/million CD4+ Tcells Standard Deviation 0.3	—
Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells Visit 3	1049.0 Specific CD4+ Tcells/million CD4+ Tcells Standard Deviation 0.8	1718.5 Specific CD4+ Tcells/million CD4+ Tcells Standard Deviation 0.4	1042.4 Specific CD4+ Tcells/million CD4+ Tcells Standard Deviation 0.3	—
Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells Visit 4	910.8 Specific CD4+ Tcells/million CD4+ Tcells Standard Deviation 0.8	2709.0 Specific CD4+ Tcells/million CD4+ Tcells Standard Deviation 0.3	734.4 Specific CD4+ Tcells/million CD4+ Tcells Standard Deviation 0.3	—

SECONDARY outcome

Timeframe: At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days)

Population: Analysis was performed on PPS for CMI. Only participants with data available for CD8+ T cells for the specified groups at the specified timepoints were included in this analysis.

CMI response is expressed as group geometric mean of the frequency of RSVPreF3-specific CD8+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-alpha, IFN-gamma, IL- 13 and IL-17. The CMI is measured in a subgroup consisting of participants with renal and lung SOT (from RSV\_IC\_1 and RSV\_IC\_2 groups) and healthy participants (from RSV\_HA group).

Outcome measures

Outcome measures
Measure	RSV_IC_2 Group n=22 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_IC_2 Group n=25 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_HA Group n=27 Participants Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	Pooled RSV_IC Group IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells Visit 1	33.9 Specific CD8+ Tcells/million CD8+ Tcells Standard Deviation 1.0	8.2 Specific CD8+ Tcells/million CD8+ Tcells Standard Deviation 1.1	27.7 Specific CD8+ Tcells/million CD8+ Tcells Standard Deviation 1.0	—
CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells Visit 2	16.0 Specific CD8+ Tcells/million CD8+ Tcells Standard Deviation 1.2	8.7 Specific CD8+ Tcells/million CD8+ Tcells Standard Deviation 1.0	13.0 Specific CD8+ Tcells/million CD8+ Tcells Standard Deviation 1.2	—
CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells Visit 3	21.7 Specific CD8+ Tcells/million CD8+ Tcells Standard Deviation 0.8	22.3 Specific CD8+ Tcells/million CD8+ Tcells Standard Deviation 1.1	21.0 Specific CD8+ Tcells/million CD8+ Tcells Standard Deviation 1.1	—
CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells Visit 4	12.0 Specific CD8+ Tcells/million CD8+ Tcells Standard Deviation 1.1	16.9 Specific CD8+ Tcells/million CD8+ Tcells Standard Deviation 0.9	13.2 Specific CD8+ Tcells/million CD8+ Tcells Standard Deviation 1.1	—

SECONDARY outcome

Timeframe: At Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 7 days (i.e., the day of vaccination and 6 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group)

Population: Analysis was performed on the Exposed set (ES) which included all participants who received the study intervention administration. Only participants with solicited administration site events at the specified timepoints were included in this analysis.

Assessed solicited administration site events included pain, erythema (redness) and swelling, at the injection site. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.

Outcome measures

Outcome measures
Measure	RSV_IC_2 Group n=131 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_IC_2 Group n=128 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_HA Group n=125 Participants Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	Pooled RSV_IC Group IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
Number Of Participants Reporting Any Solicited Administration Site Events Pain, Dosing at visit 1	95 Participants	92 Participants	95 Participants	—
Number Of Participants Reporting Any Solicited Administration Site Events Pain, Dosing at visit 3	—	81 Participants	—	—
Number Of Participants Reporting Any Solicited Administration Site Events Erythema, Dosing at visit 1	8 Participants	14 Participants	11 Participants	—
Number Of Participants Reporting Any Solicited Administration Site Events Erythema, Dosing at visit 3	—	10 Participants	—	—
Number Of Participants Reporting Any Solicited Administration Site Events Swelling, Dosing at visit 1	8 Participants	11 Participants	3 Participants	—
Number Of Participants Reporting Any Solicited Administration Site Events Swelling, Dosing at visit 3	—	6 Participants	—	—

SECONDARY outcome

Population: Analysis was performed on the ES. Only participants with solicited systemic events at the specified timepoints were included in this analysis.

Assessed solicited systemic events included fever (pyrexia), myalgia, arthralgia, headache, and fatigue. Fever is defined as body temperature greater or equal to (≥) 38 degrees Celsius (ºC). Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.

Outcome measures

Outcome measures
Measure	RSV_IC_2 Group n=131 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_IC_2 Group n=128 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_HA Group n=125 Participants Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	Pooled RSV_IC Group IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
Number Of Participants Reporting Any Solicited Systemic Events Fever , Dosing at visit 1	2 Participants	1 Participants	1 Participants	—
Number Of Participants Reporting Any Solicited Systemic Events Fever , Dosing at visit 3	—	2 Participants	—	—
Number Of Participants Reporting Any Solicited Systemic Events Myalgia, Dosing at visit 1	37 Participants	38 Participants	49 Participants	—
Number Of Participants Reporting Any Solicited Systemic Events Myalgia, Dosing at visit 3	—	38 Participants	—	—
Number Of Participants Reporting Any Solicited Systemic Events Arthralgia, Dosing at visit 1	19 Participants	15 Participants	15 Participants	—
Number Of Participants Reporting Any Solicited Systemic Events Arthralgia, Dosing at visit 3	—	19 Participants	—	—
Number Of Participants Reporting Any Solicited Systemic Events Headache, Dosing at visit 1	31 Participants	33 Participants	44 Participants	—
Number Of Participants Reporting Any Solicited Systemic Events Headache, Dosing at visit 3	—	30 Participants	—	—
Number Of Participants Reporting Any Solicited Systemic Events Fatigue, Dosing at visit 1	41 Participants	45 Participants	48 Participants	—
Number Of Participants Reporting Any Solicited Systemic Events Fatigue, Dosing at visit 3	—	47 Participants	—	—

SECONDARY outcome

Timeframe: Within 30 days (i.e., the day of vaccination and 29 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group)

Population: Analysis was performed on the ES. Only participants with unsolicited AEs at the specified timepoints were included in the analysis.

An unsolicited AE is an AE that was not included in the list of solicited events. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.

Outcome measures

Outcome measures
Measure	RSV_IC_2 Group n=131 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_IC_2 Group n=130 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_HA Group n=125 Participants Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	Pooled RSV_IC Group IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
Number Of Participants Reporting Any Unsolicited Adverse Events (AEs) At Any Dose Administration	21 Participants	60 Participants	26 Participants	—

SECONDARY outcome

Timeframe: From Visit 1 (Day 1) up to Visit 4 (Visit 3 + 30-42 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)

Population: Analysis was performed on the ES.

A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. Any SAE = occurrence of the SAE regardless of relation to study vaccination. Related SAE = SAE assessed by the investigator as related to the study vaccination. Fatal SAE = occurrence of a fatal SAE regardless of relation to study vaccination.

Outcome measures

Outcome measures
Measure	RSV_IC_2 Group n=131 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_IC_2 Group n=130 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_HA Group n=125 Participants Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	Pooled RSV_IC Group IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs Any SAEs	12 Participants	18 Participants	3 Participants	—
Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs Related SAEs	1 Participants	0 Participants	0 Participants	—
Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs Fatal SAEs	0 Participants	2 Participants	0 Participants	—

SECONDARY outcome

Population: Analysis was performed on the ES.

pIMDs are a subset of AESIs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any pIMDs = occurrence of the pIMDs regardless of relation to study vaccination. Related pIMDs = pIMDs assessed by the investigator as related to the study vaccination.

Outcome measures

Outcome measures
Measure	RSV_IC_2 Group n=131 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_IC_2 Group n=130 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_HA Group n=125 Participants Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	Pooled RSV_IC Group IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
Number Of Participants Reporting Any Potential Immune-Mediated Disease (pIMDs) And pIMDs Related To Study Intervention Related pIMD	0 Participants	0 Participants	0 Participants	—
Number Of Participants Reporting Any Potential Immune-Mediated Disease (pIMDs) And pIMDs Related To Study Intervention Any pIMD	0 Participants	0 Participants	1 Participants	—

SECONDARY outcome

Population: Analysis was performed on the ES. Only SOT participants that had data available at the specified timepoints were included in the analysis.

AESIs include the acute rejection of transplant (specific to renal and lung SOT participants). Analysis was performed only on participants that received transplant in RSV\_IC\_1 and RSV\_IC\_2 groups.

Outcome measures

Outcome measures
Measure	RSV_IC_2 Group n=131 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_IC_2 Group n=130 Participants IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).	RSV_HA Group Healthy participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	Pooled RSV_IC Group IC participants (recipients of lung or renal transplant) who received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) in RSV\_IC\_1 and RSV\_IC\_2 groups were pooled. As pre-specified in the statistical analysis plan, the IC participants were pooled for humoral immunogenicity analysis up to Visit 3 (Visit 1 + 30-60 days).
Number Of Participants With Any AEs Of Special Interest (AESIs) Specific To Renal And Lung SOT Participants	0 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: From Visit 1 (Day 1) up to study end (Visit 6 - last dose + 350-380 days), vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Visit 1 (Day 1) up to study end (Visit 6 - last dose + 350-380 days), vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Visit 1 (Day 1) up to study end (Visit 6 - last dose + 350-380 days), vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)

Outcome measures

Outcome data not reported

Adverse Events

RSV_IC_1 Group

Serious events: 12 serious events

Other events: 106 other events

Deaths: 0 deaths

RSV_IC_2 Group

Serious events: 18 serious events

Other events: 120 other events

Deaths: 2 deaths

RSV_HA Group

Serious events: 3 serious events

Other events: 111 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER