| Primary | Number of Participants With Solicited Local Adverse Events (AEs) | Number of participants with solicited local AEs were reported. Solicited local AE's included pain/tenderness, erythema, and induration/swelling. | Full analysis set (FAS) included all participants with at least one vaccination. Here, "n (number analyzed)" is defined as participants analyzed for specified category. | Posted | | Count of Participants | | Participants | | Up to 7 days after each vaccination (Up to Day 64) | | | | ID | Title | Description |
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| OG000 | Regimen 1 | Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5*10^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2*10^8 infectious units (Inf.U) on Day 57. | | OG001 | Placebo | Participants received matching placebo on Day 1 and Day 57. |
| | | Title | Denominators | Categories |
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| Post- Dose 1 | - ParticipantsOG0005
- ParticipantsOG0014
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| Primary | Number of Participants With Solicited Systemic AEs | Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included headache, fatigue, myalgia, arthralgia, chills, and fever. | FAS included all participants with at least one vaccination. Here, "n (number analyzed)" is defined as participants analyzed for specified category. | Posted | | Count of Participants | | Participants | | Up to 7 days after each vaccination (Up to Day 64) | | | | ID | Title | Description |
|---|
| OG000 | Regimen 1 | Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5*10^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2*10^8 infectious units (Inf.U) on Day 57. | | OG001 | Placebo | Participants received matching placebo on Day 1 and Day 57. |
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| Primary | Number of Participants With Unsolicited AEs | Number of participants with unsolicited AEs were reported. Unsolicited AEs included all AEs for which the participant was not specifically questioned in the participant diary. | FAS included all participants with at least one vaccination. Here, "n (number analyzed)" is defined as participants analyzed for specified category. | Posted | | Count of Participants | | Participants | | 28 days after each vaccination (Up to Day 85) | | | | ID | Title | Description |
|---|
| OG000 | Regimen 1 | Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5*10^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2*10^8 infectious units (Inf.U) on Day 57. | | OG001 | Placebo | Participants received matching placebo on Day 1 and Day 57. |
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| Primary | Number of Participants With Serious Adverse Events (SAEs) | Number of participants with SAEs were reported. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. | FAS included all participants with at least one vaccination. | Posted | | Count of Participants | | Participants | | Up to 12 months after the first vaccination (target visit Day 366) | | | | ID | Title | Description |
|---|
| OG000 | Regimen 1 | Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5*10^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2*10^8 infectious units (Inf.U) on Day 57. | | OG001 | Placebo | Participants received matching placebo on Day 1 and Day 57. |
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| Secondary | Percentage of Participants With Human Papillomavirus (HPV)-Specific CD4+ T-cell Responses: Interferon (IFN)g+ | Percentage of participants with HPV-Specific CD4+ T-cell responses for IFNg+ to peptide pools were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both). | FAS included all participants with at least one vaccination. Here, N (number of participants analyzed) is defined as participants evaluable for this outcome measure. Here, "n (number analyzed)" is defined as participants analyzed for specified category. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 57, Day 78, Day 239, and Day 366 | | | | ID | Title | Description |
|---|
| OG000 | Regimen 1 | Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5*10^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2*10^8 infectious units (Inf.U) on Day 57. | | OG001 | Placebo | Participants received matching placebo on Day 1 and Day 57. |
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| Secondary | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Interleukin (IL)2+ | Percentage of participants with HPV-Specific CD4+ T-cell responses for IL2+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both). | FAS included all participants with at least one vaccination. Here, N (number of participants analyzed) is defined as participants evaluable for this outcome measure. Here, "n (number analyzed)" is defined as participants analyzed for specified category. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 57, Day 78, Day 239, and Day 366 | | | | ID | Title | Description |
|---|
| OG000 | Regimen 1 | Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5*10^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2*10^8 infectious units (Inf.U) on Day 57. | | OG001 | Placebo | Participants received matching placebo on Day 1 and Day 57. |
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| Secondary | Percentage of Participants With HPV-Specific CD4+ T-cell Responses: Tumor Necrosis Factor (TNF)a+ | Percentage of participants with HPV-Specific CD4+ T-cell responses for TNF a+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both). | FAS included all participants with at least one vaccination. Here, N (number of participants analyzed) is defined as participants evaluable for this outcome measure. Here, "n (number analyzed)" is defined as participants analyzed for specified category. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 57, Day 78, Day 239, and Day 366 | | | | ID | Title | Description |
|---|
| OG000 | Regimen 1 | Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5*10^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2*10^8 infectious units (Inf.U) on Day 57. | | OG001 | Placebo | Participants received matching placebo on Day 1 and Day 57. |
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| Secondary | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IFNg+ | Percentage of participants with HPV-Specific CD8+ T-cell responses for IFNg+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both). | FAS included all participants with at least one vaccination. Here, N (number of participants analyzed) is defined as participants evaluable for this outcome measure. Here, "n (number analyzed)" is defined as participants analyzed for specified category. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 57, Day 78, Day 239, and Day 366 | | | | ID | Title | Description |
|---|
| OG000 | Regimen 1 | Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5*10^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2*10^8 infectious units (Inf.U) on Day 57. | | OG001 | Placebo | Participants received matching placebo on Day 1 and Day 57. |
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| Secondary | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: IL2+ | Percentage of participants with HPV-Specific CD8+ T-cell responses for IL2+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both). | FAS included all participants with at least one vaccination. Here, N (number of participants analyzed) is defined as participants evaluable for this outcome measure. Here, "n (number analyzed)" is defined as participants analyzed for specified category. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 57, Day 78, Day 239, and Day 366 | | | | ID | Title | Description |
|---|
| OG000 | Regimen 1 | Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5*10^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2*10^8 infectious units (Inf.U) on Day 57. | | OG001 | Placebo | Participants received matching placebo on Day 1 and Day 57. |
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| Secondary | Percentage of Participants With HPV-Specific CD8+ T-cell Responses: TNFa+ | Percentage of participants with HPV-Specific CD8+ T-cell responses for TNFa+ were reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. The different peptide pools for HPV16 or HPV 18 were: E2, E6/E7 and combined (E2 and E6/E7 both). | FAS included all participants with at least one vaccination. Here, N (number of participants analyzed) is defined as participants evaluable for this outcome measure. Here, "n (number analyzed)" is defined as participants analyzed for specified category. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 57, Day 78, Day 239, and Day 366 | | | | ID | Title | Description |
|---|
| OG000 | Regimen 1 | Participants received adenovirus serotype 26. human papillomavirus (Ad26.HPV)16 (Regimen 1a) or Ad26.HPV18 (Regimen 1b) at a single low dose of 5*10^10 viral particles (vp) on Day 1 followed by modified vaccinia Ankara (MVA).HPV16/18 at 2*10^8 infectious units (Inf.U) on Day 57. | | OG001 | Placebo | Participants received matching placebo on Day 1 and Day 57. |
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