| Primary | Humoral Immune Response in Terms of Respiratory Syncytial Virus (RSV)-A Neutralizing Antibody Geometric Mean Titers (GMTs) at Day 1 | RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). | Analysis was performed on the per-protocol (PP)-humoral immunity (HI) set, which included participants from the RSV_annual Group, the RSV_flexible revaccination Group and the RSV_1dose Group who had blood samples collected for testing of humoral immunity at Day 1 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion. | Posted | | Geometric Mean | 95% Confidence Interval | Titers (ED60) | | At Day 1 | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36). |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000832.4(763.4 to 907.7)
- OG001864.9(790.6 to 946.1)
- OG002896.8(815.9 to 985.8)
|
|
| |
| Primary | Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Day 31 | RSV-A neutralizing antibodies were given as GMTs and expressed as ED60. | Analysis was performed on the PP-HI set, which included participants from the RSV_annual Group, the RSV_flexible revaccination Group and the RSV_1dose Group who had blood samples collected for testing of humoral immunity at Day 31 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion. | Posted | | Geometric Mean | 95% Confidence Interval | Titers (ED60) | | At Day 31 | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36). |
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| Primary | Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 6 | RSV-A neutralizing antibodies were given as GMTs and expressed as ED60. | Analysis was performed on the PP-HI set, which included participants from the RSV_annual Group, the RSV_flexible revaccination Group and the RSV_1dose Group who had blood samples collected for testing of humoral immunity at Month 6 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion. | Posted | | Geometric Mean | 95% Confidence Interval | Titers (ED60) | | At Month 6 | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36). |
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| Primary | Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 12 | RSV-A neutralizing antibodies were given as GMTs and expressed as ED60. | Analysis was performed on the PP-HI set, which included participants from the RSV_annual Group, the RSV_flexible revaccination Group and the RSV_1dose Group who had blood samples collected for testing of humoral immunity at Month 12 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion. | Posted | | Geometric Mean | 95% Confidence Interval | Titers (ED60) | | At Month 12 | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36). |
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| Primary | Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 1 | RSV-B neutralizing antibodies measured as GMTs and expressed as ED60. | Analysis was performed on the PP-HI set, which included participants from the RSV_annual Group, the RSV_flexible revaccination Group and the RSV_1dose Group who had blood samples collected for testing of humoral immunity at Day 1 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion. | Posted | | Geometric Mean | 95% Confidence Interval | Titers (ED60) | | At Day 1 | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36). |
|
| Primary | Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 31 | RSV-B neutralizing antibodies measured as GMTs and expressed as ED60. | Analysis was performed on the PP-HI set, which included participants from the RSV_annual Group, the RSV_flexible revaccination Group and the RSV_1dose Group who had blood samples collected for testing of humoral immunity at Day 31 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion. | Posted | | Geometric Mean | 95% Confidence Interval | Titers (ED60) | | At Day 31 | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36). |
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| Primary | Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 6 | RSV-B neutralizing antibodies measured as GMTs and expressed as ED60. | Analysis was performed on the PP-HI set, which included participants from the RSV_annual Group, the RSV_flexible revaccination Group and the RSV_1dose Group who had blood samples collected for testing of humoral immunity at Month 6 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion. | Posted | | Geometric Mean | 95% Confidence Interval | Titers (ED60) | | At Month 6 | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36). |
|
| Primary | Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 12 | RSV-B neutralizing antibodies measured as GMTs and expressed as ED60. | Analysis was performed on the PP-HI set, which included participants from the RSV_annual Group, the RSV_flexible revaccination Group and the RSV_1dose Group who had blood samples collected for testing of humoral immunity at Month 12 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion. | Posted | | Geometric Mean | 95% Confidence Interval | Titers (ED60) | | At Month 12 | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36). |
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| Secondary | Humoral Immune Response in Terms of RSVPreF3 Immunoglobulin G (IgG) Antibody Geometric Mean Concentrations (GMCs) at Day 1 | Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by enzyme-linked immunosorbent assay (ELISA). The corresponding antibody GMC was expressed in Elisa Laboratory Units/milliliter (ELU/mL). | Analysis was performed on the PP-HI set, which included participants from the RSV_annual Group, the RSV_flexible revaccination Group and the RSV_1dose Group who had blood samples collected for testing of humoral immunity at Day 1 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion. | Posted | | Geometric Mean | 95% Confidence Interval | ELU/mL | | At Day 1 | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose |
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| Secondary | Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Day 31 | Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL. | Analysis was performed on the PP-HI set, which included participants from the RSV_annual Group, the RSV_flexible revaccination Group and the RSV_1dose Group who had blood samples collected for testing of humoral immunity at Day 31 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion. | Posted | | Geometric Mean | 95% Confidence Interval | ELU/mL | | At Day 31 | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36). |
|
| Secondary | Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 6 | Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL. | Analysis was performed on the PP-HI set, which included participants from the RSV_annual Group, the RSV_flexible revaccination Group and the RSV_1dose Group who had blood samples collected for testing of humoral immunity at Month 6 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion. | Posted | | Geometric Mean | 95% Confidence Interval | ELU/mL | | At Month 6 | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36). |
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| Secondary | Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 12 | Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL. | Analysis was performed on the PP-HI set, which included participants from the RSV_annual Group, the RSV_flexible revaccination Group and the RSV_1dose Group who had blood samples collected for testing of humoral immunity at Month 12 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion. | Posted | | Geometric Mean | 95% Confidence Interval | ELU/mL | | At Month 12 | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36). |
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| Secondary | Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 18 | Month 18 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). | | Not Posted | May 2027 | | | | | At Month 18 | | Participants | | | | |
| Secondary | Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 24 | Month 24 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). | | Not Posted | May 2027 | | | | | At Month 24 | | Participants | | | | |
| Secondary | Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 30 | Month 30 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). | | Not Posted | May 2027 | | | | | At Month 30 | | Participants | | | | |
| Secondary | Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 36 | Month 36 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). | | Not Posted | May 2027 | | | | | At Month 36 | | Participants | | | | |
| Secondary | Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 13 | Month 13 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). | | Not Posted | May 2027 | | | | | At Month 13 | | Participants | | | | |
| Secondary | Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 25 | Month 25 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). | | Not Posted | May 2027 | | | | | At Month 25 | | Participants | | | | |
| Secondary | Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 18 | Month 18 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). | | Not Posted | May 2027 | | | | | At Month 18 | | Participants | | | | |
| Secondary | Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 24 | Month 24 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). | | Not Posted | May 2027 | | | | | At Month 24 | | Participants | | | | |
| Secondary | Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 30 | Month 30 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). | | Not Posted | May 2027 | | | | | At Month 30 | | Participants | | | | |
| Secondary | Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 36 | Month 36 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). | | Not Posted | May 2027 | | | | | At Month 36 | | Participants | | | | |
| Secondary | Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 13 | Month 13 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). | | Not Posted | May 2027 | | | | | At Month 13 | | Participants | | | | |
| Secondary | Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 25 | Month 25 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60). | | Not Posted | May 2027 | | | | | At Month 25 | | Participants | | | | |
| Secondary | Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 18 | Month 18 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL. | | Not Posted | May 2027 | | | | | At Month 18 | | Participants | | | | |
| Secondary | Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 24 | Month 24 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL. | | Not Posted | May 2027 | | | | | At Month 24 | | Participants | | | | |
| Secondary | Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 30 | Month 30 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL. | | Not Posted | May 2027 | | | | | At Month 30 | | Participants | | | | |
| Secondary | Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 36 | Month 36 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL. | | Not Posted | May 2027 | | | | | At Month 36 | | Participants | | | | |
| Secondary | Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 13 | Month 13 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL. | | Not Posted | May 2027 | | | | | At Month 13 | | Participants | | | | |
| Secondary | Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 25 | Month 25 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL. | | Not Posted | May 2027 | | | | | At Month 25 | | Participants | | | | |
| Secondary | Cell-Mediated Immunity (CMI) Response in Terms of Frequency of RSVPreF3-specific Cluster of Differentiation CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1 | Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. | Analysis was performed on the PP-CMI set, which included participants from the RSV_annual Group, the RSV_flexible revaccination Group and the RSV_1dose Group who had blood samples collected for testing of CMI at Day 1, minus participants with protocol deviations that lead to exclusion. | Posted | | Median | Inter-Quartile Range | CD4 atl2_7m/ million of CD4+ cells | | At Day 1 | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose |
|
| Secondary | CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1 | Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations. | Analysis was performed on the PP-CMI set, which included participants from the RSV_annual Group, the RSV_flexible revaccination Group and the RSV_1dose Group who had blood samples collected for testing of CMI at Day 1, minus participants with protocol deviations that lead to exclusion. | Posted | | Median | Inter-Quartile Range | CD8 atl2_7m/ million of CD8+ cells | | At Day 1 | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36). |
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| Secondary | CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31 | Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations. | Analysis was performed on the PP-CMI set, which included participants from the RSV_annual Group, the RSV_flexible revaccination Group and the RSV_1dose Group who had blood samples collected for testing of CMI at Day 31, minus participants with protocol deviations that lead to exclusion. | Posted | | Median | Inter-Quartile Range | CD4 atl2_7m/ million of CD4+ cells | | At Day 31 | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36). |
|
| Secondary | CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31 | Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations. | Analysis was performed on the PP-CMI set, which included participants from the RSV_annual Group, the RSV_flexible revaccination Group and the RSV_1dose Group who had blood samples collected for testing of CMI at Day 31, minus participants with protocol deviations that lead to exclusion. | Posted | | Median | Inter-Quartile Range | CD8 atl2_7m/ million of CD8+ cells | | At Day 31 | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36). |
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| Secondary | CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 6 | Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations. | Analysis was performed on the PP-CMI set, which included participants from the RSV_annual Group, the RSV_flexible revaccination Group and the RSV_1dose Group who had blood samples collected for testing of CMI at Month 6, minus participants with protocol deviations that lead to exclusion. | Posted | | Median | Inter-Quartile Range | CD4 atl2_7m/ million of CD4+ cells | | At Month 6 | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36). |
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| Secondary | CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 6 | Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations. | Analysis was performed on the PP-CMI set, which included participants from the RSV_annual Group, the RSV_flexible revaccination Group and the RSV_1dose Group who had blood samples collected for testing of CMI at Month 6, minus participants with protocol deviations that lead to exclusion. | Posted | | Median | Inter-Quartile Range | CD8 atl2_7m/ million of CD8+ cells | | At Month 6 | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36). |
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| Secondary | CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12 | Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations. | Analysis was performed on the PP-CMI set, which included participants from the RSV_annual Group, the RSV_flexible revaccination Group and the RSV_1dose Group who had blood samples collected for testing of CMI at Month 12, minus participants with protocol deviations that lead to exclusion. | Posted | | Median | Inter-Quartile Range | CD4 atl2_7m/ million of CD4+ cells | | At Month 12 | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36). |
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| Secondary | CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12 | Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations. | Analysis was performed on the PP-CMI set, which included participants from the RSV_annual Group, the RSV_flexible revaccination Group and the RSV_1dose Group who had blood samples collected for testing of CMI at Month 12, minus participants with protocol deviations that lead to exclusion. | Posted | | Median | Inter-Quartile Range | CD8 atl2_7m/ million of CD8+ cells | | At Month 12 | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36). |
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| Secondary | CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 18 | Month 18 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. | | Not Posted | May 2027 | | | | | At Month 18 | | Participants | | | | |
| Secondary | CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 18 | Month 18 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. | | Not Posted | May 2027 | | | | | At Month 18 | | Participants | | | | |
| Secondary | CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 24 | Month 24 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. | | Not Posted | May 2027 | | | | | At Month 24 | | Participants | | | | |
| Secondary | CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 24 | Month 24 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. | | Not Posted | May 2027 | | | | | At Month 24 | | Participants | | | | |
| Secondary | CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 30 | Month 30 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. | | Not Posted | May 2027 | | | | | At Month 30 | | Participants | | | | |
| Secondary | CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 30 | Month 30 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. | | Not Posted | May 2027 | | | | | At Month 30 | | Participants | | | | |
| Secondary | CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 36 | Month 36 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. | | Not Posted | May 2027 | | | | | At Month 36 | | Participants | | | | |
| Secondary | CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 36 | Month 36 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. | | Not Posted | May 2027 | | | | | At Month 36 | | Participants | | | | |
| Secondary | CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 13 | Month 13 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. | | Not Posted | May 2027 | | | | | At Month 13 | | Participants | | | | |
| Secondary | CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 13 | Month 13 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. | | Not Posted | May 2027 | | | | | At Month 13 | | Participants | | | | |
| Secondary | CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 25 | Month 25 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. | | Not Posted | May 2027 | | | | | At Month 25 | | Participants | | | | |
| Secondary | CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 25 | Month 25 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. | | Not Posted | May 2027 | | | | | At Month 25 | | Participants | | | | |
| Secondary | Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Day 1 | The solicited administration-site events were erythema, pain and swelling at the injection site. | The analysis was performed on the Exposed Set (ES), which included all participants who received at least 1 dose of the study intervention and for whom solicited administration-site data was available for the specific duration. | Posted | | Count of Participants | | Participants | | During the 4-day follow up period after first vaccination (vaccine administered on Day 1) | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36). |
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| Secondary | Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Month 12 | Month 12 to Month 18 data will be disclosed during final posting. The solicited administration-site events were erythema, pain and swelling at the injection site. | | Not Posted | | | | | | During the 4-day follow up period after vaccination (vaccine administered at Month 12) | | Participants | | | | |
| Secondary | Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Month 24 | Month 24 data will be disclosed during final posting. The solicited administration-site events were erythema, pain and swelling at the injection site. | | Not Posted | May 2027 | | | | | During the 4-day follow up period after vaccination (vaccine administered at Month 24) | | Participants | | | | |
| Secondary | Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1 | The solicited systemic events included arthralgia, fatigue, fever (defined as temperature equal to or above 38.0 degree Celsius [°C]), headache and myalgia. | The analysis was performed on the ES, which included all participants who received at least 1 dose of the study intervention and for whom solicited systemic data was available for the specific duration. | Posted | | Count of Participants | | Participants | | During the 4-day follow up period after vaccination (vaccine administered on Day 1) | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36). |
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| Secondary | Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Month 12 | Month 12 to Month 18 data will be disclosed during final posting. The solicited systemic events included arthralgia, fatigue, fever (defined as temperature equal to or above 38.0°C), headache and myalgia. | | Not Posted | | | | | | During the 4-day follow up period after vaccination (vaccine administered at Month 12) | | Participants | | | | |
| Secondary | Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Month 24 | Month 24 data will be disclosed during final posting. The solicited systemic events included arthralgia, fatigue, fever (defined as temperature equal to or above 38.0 degree Celsius (°C)), headache and myalgia. | | Not Posted | May 2027 | | | | | During the 4-day follow up period after vaccination (vaccine administered at Month 24) | | Participants | | | | |
| Secondary | Number of Participants With Any Unsolicited Adverse Events (AEs) Following Vaccination at Day 1 | An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of study intervention, 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. | The analysis was performed on the ES, which included all participants who received at least 1 dose of the study intervention and for whom safety data was available for 30 days following vaccination at Day 1. | Posted | | Count of Participants | | Participants | | During the 30-day follow up period after vaccination (vaccine administered on Day 1) | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). |
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| Secondary | Number of Participants With Any Unsolicited AEs Following Vaccination at Month 12 | Month 12 to Month 18 data will be disclosed during final posting. An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of study intervention, 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. | | Not Posted | | | | | | During the 4-day follow up period after vaccination (vaccine administered at Month 12) | | Participants | | | | |
| Secondary | Number of Participants With Any Unsolicited AEs Following Vaccination at Month 24 | Month 24 data will be disclosed during final posting. An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of study intervention, 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. | | Not Posted | May 2027 | | | | | During the 4-day follow up period after vaccination (vaccine administered at Month 24) | | Participants | | | | |
| Secondary | Number of Participants With Serious Adverse Events (SAE) Following Vaccination at Day 1 | An 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. | The analysis was performed on the ES, which included all participants who received at least 1 dose of the study intervention. | Posted | | Count of Participants | | Participants | | From first vaccination (Day 1) up to 6 months post-Dose 1 (Month 6) | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36). |
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| Secondary | Number of Participants With SAEs Following Vaccination at Month 12 | Month 12 to Month 18 data will be disclosed during final posting. An 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. | | Not Posted | | | | | | During the 4-day follow up period after vaccination (vaccine administered at Month 12) | | Participants | | | | |
| Secondary | Number of Participants With SAEs Following Vaccination at Month 24 | Month 24 data will be disclosed during final posting. An 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. | | Not Posted | May 2027 | | | | | During the 4-day follow up period after vaccination (vaccine administered at Month 24) | | Participants | | | | |
| Secondary | Number of Participants Reporting Any Potential Immune-mediated Disease (pIMD) Following Vaccination at Day 1 | pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. | The analysis was performed on the ES, which included all participants who received at least 1 dose of the study intervention. | Posted | | Count of Participants | | Participants | | From first vaccination (Day 1) up to 6 months post-Dose 1 (Month 6) | | | | ID | Title | Description |
|---|
| OG000 | RSV_annual | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36). | | OG001 | RSV_flexible Revaccination | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36). | | OG002 | RSV_1dose | Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36). |
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| Secondary | Number of Participants Reporting Any pIMD Following Vaccination at Month 12 | Month 12 to Month 18 data will be disclosed during final posting. pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. | | Not Posted | | | | | | During the 4-day follow up period after vaccination (vaccine administered at Month 12) | | Participants | | | | |
| Secondary | Number of Participants Reporting Any pIMD Following Vaccination at Month 24 | Month 24 data will be disclosed during final posting. pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. | | Not Posted | May 2027 | | | | | During the 4-day follow up period after vaccination (vaccine administered at Month 24) | | Participants | | | | |
| Secondary | Number of Participants With a Fatal SAE, Related SAE and Related pIMDs | A fatal SAE is any untoward medical occurrence that results in death. A related SAE is an SAE considered to be causally related to the study intervention. A related pIMD is a pIMD considered to be causally related to the study intervention. The study is ongoing at the time of the results posting. Results for Months 18 up to study end (Month 36) will be updated during final posting. | | Not Posted | | | | | | From first vaccination (Day 1) up to study end (Month 36) | | Participants | | | | |