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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003591-13 | EudraCT Number |
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The purpose of this study to evaluate the safety and immunogenicity of a 2-dose regimen of 9vHPV vaccine, where the first dose is administered concomitantly with a first dose of a 2-dose regimen of mRNA-1273 vaccine versus nonconcomitant administration of 9vHPV and mRNA-1273 vaccines in boys and girls 9 to 11 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concomitant Group | Experimental | Participants will receive Dose 1 of 9-valent human papillomavirus [Types 6, 11, 16, 18, 31, 33, 45, 52, 58] (9vHPV) vaccine administered into the left arm as an intramuscular (IM) injection, AND Dose 1 of the messenger ribonucleic acid (mRNA)-1273 vaccine administered into the right arm as an IM injection on Day 1; participants will then receive Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 6. |
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| Non-concomitant Group | Experimental | Participants will receive Dose 1 of the mRNA-1273 vaccine administered into the right arm as an IM injection on Day 1 and Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1. Participants will then receive Dose 1 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 2 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 8. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9vHPV Vaccine | Biological | 9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular (IM) injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) | Antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured using a competitive Luminex immunoassay (cLIA). Per protocol, antibody titers were expressed as milli Merck units/milliliter (mMU/mL). Geometric Mean Titers (GMTs) are reported for both arms for all randomized participants included in the per-protocol immunogenicity (PPI) population. The PPI population is HPV-type specific. | Up approximately 4 weeks post vaccination with 9vHPV Dose 2 |
| Geometric Mean Concentrations of SARS-CoV-2 Spike Protein-Specific Binding Antibodies | The geometric mean concentration (GMC) of serum-derived antibodies to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike protein was determined using an electrochemiluminescence (ECL) assay. GMCs are reported for both arms for all randomized participants included in the mRNA-1273 per-protocol (mRNA-1273-PP) population. | Up approximately 4 weeks post vaccination with mRNA-1273 Dose 2 |
| Percentage of Participants With ≥1 Solicited Injection-site Adverse Event (AE) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited AEs are predefined local AEs (at the injection site) for which the participant was specifically questioned, and noted by the participant in their vaccine report card (VRC). Per protocol, the percentage of participants with ≥1 solicited injection site AE has been reported separately based on injection site for participants in the Concomitant Group (Day 1 mRNA-1273 Dose 1 right arm; Day 1 9vHPV Dose 1 left arm; Month 1 mRNA-1273 Dose 2 right arm; Month 6 9vHPV Dose 2 left arm) and Non-Concomitant Group (Day 1 mRNA-1273 Dose 1 right arm; Month 1 mRNA-1273 Dose 2 right arm; Month 2 9vHPV Dose 1 left arm; Month 8 9vHPV Dose 2 left arm). Per protocol, reporting for Concomitant Group Day 1 Dose 1 separated by injection site is specific to this outcome only and does not apply to other safety outcomes. | Up to approximately Day 7 post vaccination with any study vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Seroconvert to Each of the 9vHPV Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 Following Administration of a 2-Dose Regimen of 9vHPV Vaccine | Serum-derived antibodies to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were measured with a competitive luminex immunoassay (cLIA). Seroconversion is defined as changing from cLIA anti-HPV seronegative serum antibodies for 9vHPV types at pre-vaccination to cLIA anti-HPV seropositive at 4 weeks post vaccination with 9vHPV Dose 2. A participant with anti-HPV cLIA titer at or above the serostatus cutoff values of the cLIA for a given HPV type is considered seropositive for that HPV type. The serostatus cutoffs (milli Merck units/milliliter (mMU/mL) for HPV types were as follows: HPV Type 6: ≥34, HPV Type 11: ≥25; HPV Type 16: ≥32, HPV Type 18: ≥26, HPV Type 31: ≥15, HPV Type 33: ≥10, HPV Type 45: ≥10, HPV Type 52: ≥14, and HPV Type 58: ≥10. Percentage of participants who seroconverted are reported for both arms for all randomized participants included in the PPI population. The PPI population is HPV-type specific. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cognitive Clinical Trials, LLC ( Site 0054) | Phoenix | Arizona | 85044 | United States | ||
| Eclipse Clinical Research ( Site 0095) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Concomitant Group | Participants received Dose 1 of 9-valent human papillomavirus [Types 6, 11, 16, 18, 31, 33, 45, 52, 58] (9vHPV) vaccine administered into the left arm as an intramuscular (IM) injection, AND Dose 1 of the messenger ribonucleic acid (mRNA)-1273 vaccine administered into the right arm as an IM injection on Day 1; participants then received Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 6. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2023 |
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| mRNA-1273 Vaccine | Biological | mRNA-1273 50 mcg dose administered as a 0.25-mL IM injection |
|
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| Percentage of Participants With ≥1 Solicited Systemic AE | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited AEs are predefined systemic events for which the participant is specifically questioned, and which are noted by the participant in their VRC. Per protocol the percentage of participants who experienced ≥1 solicited systemic (affecting the whole body) AE are reported here for participants in the Concomitant (Day 1 mRNA-1273 Dose 1 right arm + 9vHPV Dose 1 left arm; Month 1 mRNA-1273 Dose 2 right arm; Month 6 9vHPV Dose 2 left arm) and Non-Concomitant Groups (Day 1 mRNA-1273 Dose 1 right arm; Month 1 mRNA-1273 Dose 2 right arm; Month 2 9vHPV Dose 1 left arm; Month 8 9vHPV Dose 2 left arm). Per protocol, reporting is based on time of injection; as 9vHPV Dose 1 AND mRNA-1273 Dose 1 were both given on Day 1 of the Concomitant Group they have been combined below. | Up to approximately Day 7 post vaccination with any study vaccine |
| Percentage of Participants With ≥1 Serious Adverse Event (SAE) | A serious adverse event (SAE) was defined as one that results in death, is life threatening, or requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical event that may require medical intervention. Per protocol the percentage of participants who experienced ≥1 SAE are reported here for participants in the Concomitant (Day 1 mRNA-1273 Dose 1 right arm + 9vHPV Dose 1 left arm; Month 1 mRNA-1273 Dose 2 right arm; Month 6 9vHPV Dose 2 left arm) and Non-Concomitant Groups (Day 1 mRNA-1273 Dose 1 right arm; Month 1 mRNA-1273 Dose 2 right arm; Month 2 9vHPV Dose 1 left arm; Month 8 9vHPV Dose 2 left arm). Per protocol, reporting is based on time of injection; as 9vHPV Dose 1 AND mRNA-1273 Dose 1 were both given on Day 1 of the Concomitant Group they have been combined below. | Up to approximately Day 28 post vaccination with any study vaccine |
| Percentage of Participants With ≥1 Vaccine-Related SAE | A SAE was defined as one that results in death, is life threatening, or requires hospitalization/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is a congenital anomaly/birth defect, or other important medical event that may require medical intervention. An SAE judged by the investigator to be related to the study vaccine is a vaccine-related SAE. Per protocol the percentage of participants who experienced ≥1 vaccine-related SAE are reported here for participants in Concomitant (Day 1 mRNA-1273 Dose 1 right arm + 9vHPV Dose 1 left arm; Month 1 mRNA-1273 Dose 2 right arm; Month 6 9vHPV Dose 2 left arm) and Non-Concomitant Groups (Day 1 mRNA-1273 Dose 1 right arm; Month 1 mRNA-1273 Dose 2 right arm; Month 2 9vHPV Dose 1 left arm; Month 8 9vHPV Dose 2 left arm). Per protocol, reporting is based on time of injection; as 9vHPV Dose 1 AND mRNA-1273 Dose 1 were both given on Day 1 of the Concomitant Group they have been combined below. | Up to approximately 9 Months |
| Up to approximately 4 weeks post vaccination with 9vHPV Dose 2 |
| Percentage of Participants Who Experience Seroresponse Following Administration of a 2-Dose Regimen of mRNA-1273 Vaccine | Serum-derived antibodies to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike protein was determined using an electrochemiluminescence (ECL) assay. Seroresponse is defined as a ≥4-fold rise in SARS-CoV-2 spike protein-specific binding antibody concentration from baseline to 4 weeks post vaccination with mRNA-1273 Dose 2. Percentage of participants who experience seroresponse are reported for both arms for all randomized participants included in the mRNA-1273-PP population. | Up to approximately 4 weeks post vaccination with mRNA-1273 Dose 2 |
| Tucson |
| Arizona |
| 85745 |
| United States |
| Children's Clinic of Jonesboro, PA ( Site 0044) | Jonesboro | Arkansas | 72401 | United States |
| Preferred Research Partners Inc. ( Site 0092) | Little Rock | Arkansas | 72211 | United States |
| Coast Clinical Research, LLC ( Site 0027) | Bellflower | California | 90706 | United States |
| Ark Clinical Research ( Site 0098) | Long Beach | California | 90815 | United States |
| Valley Clinical Trials Inc. ( Site 0004) | Northridge | California | 91325 | United States |
| Medical Center for Clinical Research ( Site 0051) | San Diego | California | 92120 | United States |
| Ark Clinical Research ( Site 0108) | Tustin | California | 92780 | United States |
| Emerson Clinical Research Institute ( Site 0021) | Washington D.C. | District of Columbia | 20011 | United States |
| Accel Research Sites-DeLand Clinical Research Unit ( Site 0066) | DeLand | Florida | 32720 | United States |
| Advanced Research for Health Improvement, LLC ( Site 0012) | Immokalee | Florida | 34142 | United States |
| Acevedo Clinical Research Associates ( Site 0001) | Miami | Florida | 33142 | United States |
| Alpha Science Research ( Site 0067) | Miami | Florida | 33186 | United States |
| Advanced Research For Health Improvement LLC ( Site 0075) | Naples | Florida | 34102 | United States |
| Comprehensive Clinical Research ( Site 0038) | West Palm Beach | Florida | 33409 | United States |
| Atlanta Center for Medical Research ( Site 0055) | Atlanta | Georgia | 30331 | United States |
| Mount Vernon Clinical Research ( Site 0053) | Sandy Springs | Georgia | 30328 | United States |
| Clinical Research Prime ( Site 0088) | Idaho Falls | Idaho | 83404 | United States |
| CBH Health ( Site 0019) | Gaithersburg | Maryland | 20877 | United States |
| SKY Integrative Medical Center/SKYCRNG ( Site 0084) | Ridgeland | Mississippi | 39157 | United States |
| Midwest Children's Health Research Institute ( Site 0003) | Lincoln | Nebraska | 68505 | United States |
| Certified Research Associates ( Site 0090) | Cortland | New York | 13045 | United States |
| Corning Center for Clinical Research ( Site 0091) | Horseheads | New York | 14845 | United States |
| Carolina Institute for Clinical Research, LLC ( Site 0042) | Fayetteville | North Carolina | 28303 | United States |
| M3 Wake Research, Inc. ( Site 0014) | Raleigh | North Carolina | 27612 | United States |
| Dayton Clinical Research ( Site 0028) | Dayton | Ohio | 45409 | United States |
| Thomas Jefferson University - Family and Community Medicine ( Site 0006) | Philadelphia | Pennsylvania | 19107 | United States |
| WR-ClinSearch ( Site 0049) | Chattanooga | Tennessee | 37421 | United States |
| DermResearch, Inc. ( Site 0056) | Austin | Texas | 78759 | United States |
| South Texas Clinical Research ( Site 0024) | Corpus Christi | Texas | 78404 | United States |
| South Texas Pediatric Research Group ( Site 0094) | Del Rio | Texas | 78840 | United States |
| West Houston Clinical Research Services ( Site 0078) | Houston | Texas | 77055 | United States |
| Next Level Urgent Care, LLC ( Site 0099) | Houston | Texas | 77057 | United States |
| Milton Haber, M.D. ( Site 0069) | Laredo | Texas | 78041 | United States |
| University of Texas Medical Branch ( Site 0026) | League City | Texas | 77573 | United States |
| University of Utah ( Site 0076) | Salt Lake City | Utah | 84132 | United States |
| Velocity Clinical Research, Salt Lake City ( Site 0025) | West Jordan | Utah | 84088 | United States |
| FG001 | Non-concomitant Group | Participants received Dose 1 of the mRNA-1273 vaccine administered into the right arm as an IM injection on Day 1 and Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1. Participants then received Dose 1 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 2 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 8. |
| Vaccinated: mRNA-1273 Dose 1 |
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| Vaccinated: 9vHPV Dose 1 |
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| Vaccinated: mRNA-1273 Dose 2 |
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| Vaccinated: 9vHPV Dose 2 |
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| Concomitant Group Dose 1 Day 1: 9vHPV |
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| Concomitant Group Dose 1 Day 1: mRNA-1273 |
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| Concomitant Group Dose 2 Month 1: mRNA-1273 |
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| Concomitant Group Dose 2 Month 6: 9vHPV |
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| Non-concomitant Group Dose 1 Day 1: mRNA-1273 |
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| Non-concomitant Group Dose 2 Month 1: mRNA-1273 |
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| Non-concomitant Group Dose 1 Month 2: 9vHPV |
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| Non-concomitant Group Dose 2 Month 8: 9vHPV |
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| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Concomitant Group | Participants received Dose 1 of 9-valent human papillomavirus [Types 6, 11, 16, 18, 31, 33, 45, 52, 58] (9vHPV) vaccine administered into the left arm as an intramuscular (IM) injection, AND Dose 1 of the messenger ribonucleic acid (mRNA)-1273 vaccine administered into the right arm as an IM injection on Day 1; participants then received Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 6. |
| BG001 | Non-concomitant Group | Participants received Dose 1 of the mRNA-1273 vaccine administered into the right arm as an IM injection on Day 1 and Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1. Participants then received Dose 1 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 2 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 8. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) | Antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured using a competitive Luminex immunoassay (cLIA). Per protocol, antibody titers were expressed as milli Merck units/milliliter (mMU/mL). Geometric Mean Titers (GMTs) are reported for both arms for all randomized participants included in the per-protocol immunogenicity (PPI) population. The PPI population is HPV-type specific. | The analysis population is HPV-type specific; the number of participants analyzed is the total number of participants for inclusion in any HPV type-specific PPI. The type-specific PPI population includes all randomized participants who were seronegative pre 9vHPV vaccination to the relevant HPV type(s); had all protocol planned 9vHPV vaccinations; had evaluable serology results post Dose 2; had no protocol deviations that may affect evaluation of participant's immune response to vaccination. | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | Up approximately 4 weeks post vaccination with 9vHPV Dose 2 |
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| Primary | Geometric Mean Concentrations of SARS-CoV-2 Spike Protein-Specific Binding Antibodies | The geometric mean concentration (GMC) of serum-derived antibodies to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike protein was determined using an electrochemiluminescence (ECL) assay. GMCs are reported for both arms for all randomized participants included in the mRNA-1273 per-protocol (mRNA-1273-PP) population. | mRNA-1273-PP population: all randomized participants who; had all protocol planned mRNA-1273 vaccinations; had evaluable serology results post mRNA-1273 Dose 2 vaccination; no protocol deviations that may affect evaluation of participant's immune response to mRNA-1273 vaccination. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | Up approximately 4 weeks post vaccination with mRNA-1273 Dose 2 |
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| Primary | Percentage of Participants With ≥1 Solicited Injection-site Adverse Event (AE) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited AEs are predefined local AEs (at the injection site) for which the participant was specifically questioned, and noted by the participant in their vaccine report card (VRC). Per protocol, the percentage of participants with ≥1 solicited injection site AE has been reported separately based on injection site for participants in the Concomitant Group (Day 1 mRNA-1273 Dose 1 right arm; Day 1 9vHPV Dose 1 left arm; Month 1 mRNA-1273 Dose 2 right arm; Month 6 9vHPV Dose 2 left arm) and Non-Concomitant Group (Day 1 mRNA-1273 Dose 1 right arm; Month 1 mRNA-1273 Dose 2 right arm; Month 2 9vHPV Dose 1 left arm; Month 8 9vHPV Dose 2 left arm). Per protocol, reporting for Concomitant Group Day 1 Dose 1 separated by injection site is specific to this outcome only and does not apply to other safety outcomes. | Per protocol, the safety analyses population consists of all randomized participants who received at least 1 dose of any study vaccine. Participants are included in the treatment group corresponding to the study vaccine they actually received. Per protocol, reporting for Concomitant Group Day 1 Dose 1 separated by injection site is specific to this outcome only and does not apply to other safety outcomes. | Posted | Number | Percentage of Participants | Up to approximately Day 7 post vaccination with any study vaccine |
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| Primary | Percentage of Participants With ≥1 Solicited Systemic AE | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited AEs are predefined systemic events for which the participant is specifically questioned, and which are noted by the participant in their VRC. Per protocol the percentage of participants who experienced ≥1 solicited systemic (affecting the whole body) AE are reported here for participants in the Concomitant (Day 1 mRNA-1273 Dose 1 right arm + 9vHPV Dose 1 left arm; Month 1 mRNA-1273 Dose 2 right arm; Month 6 9vHPV Dose 2 left arm) and Non-Concomitant Groups (Day 1 mRNA-1273 Dose 1 right arm; Month 1 mRNA-1273 Dose 2 right arm; Month 2 9vHPV Dose 1 left arm; Month 8 9vHPV Dose 2 left arm). Per protocol, reporting is based on time of injection; as 9vHPV Dose 1 AND mRNA-1273 Dose 1 were both given on Day 1 of the Concomitant Group they have been combined below. | Per protocol, the safety analyses population consists of all randomized participants who received at least 1 dose of any study vaccine. Participants are included in the treatment group corresponding to the study vaccine they actually received. Per protocol, reporting is based on time of injection; as 9vHPV Dose 1 AND mRNA-1273 Dose 1 were both given on Day 1 of the Concomitant Group they have been combined below. | Posted | Number | Percentage of Participants | Up to approximately Day 7 post vaccination with any study vaccine |
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| Primary | Percentage of Participants With ≥1 Serious Adverse Event (SAE) | A serious adverse event (SAE) was defined as one that results in death, is life threatening, or requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical event that may require medical intervention. Per protocol the percentage of participants who experienced ≥1 SAE are reported here for participants in the Concomitant (Day 1 mRNA-1273 Dose 1 right arm + 9vHPV Dose 1 left arm; Month 1 mRNA-1273 Dose 2 right arm; Month 6 9vHPV Dose 2 left arm) and Non-Concomitant Groups (Day 1 mRNA-1273 Dose 1 right arm; Month 1 mRNA-1273 Dose 2 right arm; Month 2 9vHPV Dose 1 left arm; Month 8 9vHPV Dose 2 left arm). Per protocol, reporting is based on time of injection; as 9vHPV Dose 1 AND mRNA-1273 Dose 1 were both given on Day 1 of the Concomitant Group they have been combined below. | Per protocol, the safety analyses population consists of all randomized participants who received at least 1 dose of any study vaccine. Participants are included in thetreatment group corresponding to the study vaccine they actually received. Per protocol, reporting is based on time of injection; as 9vHPV Dose 1 AND mRNA-1273 Dose 1were both given on Day 1 of the Concomitant Group they have been combined below. | Posted | Number | Percentage of Participants | Up to approximately Day 28 post vaccination with any study vaccine |
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| Primary | Percentage of Participants With ≥1 Vaccine-Related SAE | A SAE was defined as one that results in death, is life threatening, or requires hospitalization/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is a congenital anomaly/birth defect, or other important medical event that may require medical intervention. An SAE judged by the investigator to be related to the study vaccine is a vaccine-related SAE. Per protocol the percentage of participants who experienced ≥1 vaccine-related SAE are reported here for participants in Concomitant (Day 1 mRNA-1273 Dose 1 right arm + 9vHPV Dose 1 left arm; Month 1 mRNA-1273 Dose 2 right arm; Month 6 9vHPV Dose 2 left arm) and Non-Concomitant Groups (Day 1 mRNA-1273 Dose 1 right arm; Month 1 mRNA-1273 Dose 2 right arm; Month 2 9vHPV Dose 1 left arm; Month 8 9vHPV Dose 2 left arm). Per protocol, reporting is based on time of injection; as 9vHPV Dose 1 AND mRNA-1273 Dose 1 were both given on Day 1 of the Concomitant Group they have been combined below. | Per protocol, the safety analyses population consists of all randomized participants who received at least 1 dose of any study vaccine. Participants are included in the treatment group corresponding to the study vaccine they actually received. Per protocol, reporting is based on time of injection; as 9vHPV Dose 1 AND mRNA-1273 Dose 1 were both given on Day 1 of the Concomitant Group they have been combined below. | Posted | Number | Percentage of Participants | Up to approximately 9 Months |
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| Secondary | Percentage of Participants Who Seroconvert to Each of the 9vHPV Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 Following Administration of a 2-Dose Regimen of 9vHPV Vaccine | Serum-derived antibodies to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were measured with a competitive luminex immunoassay (cLIA). Seroconversion is defined as changing from cLIA anti-HPV seronegative serum antibodies for 9vHPV types at pre-vaccination to cLIA anti-HPV seropositive at 4 weeks post vaccination with 9vHPV Dose 2. A participant with anti-HPV cLIA titer at or above the serostatus cutoff values of the cLIA for a given HPV type is considered seropositive for that HPV type. The serostatus cutoffs (milli Merck units/milliliter (mMU/mL) for HPV types were as follows: HPV Type 6: ≥34, HPV Type 11: ≥25; HPV Type 16: ≥32, HPV Type 18: ≥26, HPV Type 31: ≥15, HPV Type 33: ≥10, HPV Type 45: ≥10, HPV Type 52: ≥14, and HPV Type 58: ≥10. Percentage of participants who seroconverted are reported for both arms for all randomized participants included in the PPI population. The PPI population is HPV-type specific. | The analysis population is HPV-type specific; the number of participants analyzed is the total number of participants for inclusion in any HPV type-specific PPI. The type-specific PPI population includes all randomized participants who were seronegative pre 9vHPV vaccination to the relevant HPV type(s); had all protocol planned 9vHPV vaccinations; had evaluable serology results post Dose 2; had no protocol deviations that may affect evaluation of participant's immune response to vaccination. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 4 weeks post vaccination with 9vHPV Dose 2 |
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| Secondary | Percentage of Participants Who Experience Seroresponse Following Administration of a 2-Dose Regimen of mRNA-1273 Vaccine | Serum-derived antibodies to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike protein was determined using an electrochemiluminescence (ECL) assay. Seroresponse is defined as a ≥4-fold rise in SARS-CoV-2 spike protein-specific binding antibody concentration from baseline to 4 weeks post vaccination with mRNA-1273 Dose 2. Percentage of participants who experience seroresponse are reported for both arms for all randomized participants included in the mRNA-1273-PP population. | mRNA-1273-PP population: all randomized participants who; received all protocol planned mRNA-1273 vaccinations; had evaluable serology results from samples collected post mRNA-1273 Dose 2 vaccination; no protocol deviations that may affect evaluation of participant's immune response to mRNA-1273 vaccination. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 4 weeks post vaccination with mRNA-1273 Dose 2 |
|
Up to approximately 9 Months
Population for All-cause mortality was All Randomized Participants. Population for Non-serious adverse events and serious adverse events was All Participants as Treated (APaT). The APaT population consists of all randomized participants who received at least 1 dose of any study vaccine; participants were included in the treatment group corresponding to the study vaccine they actually received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Concomitant Group | Participants received Dose 1 of 9-valent human papillomavirus [Types 6, 11, 16, 18, 31, 33, 45, 52, 58] (9vHPV) vaccine administered into the left arm as an intramuscular (IM) injection, AND Dose 1 of the messenger ribonucleic acid (mRNA)-1273 vaccine administered into the right arm as an IM injection on Day 1; participants then received Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 6. | 0 | 82 | 0 | 81 | 55 | 81 |
| EG001 | Non-concomitant Group | Participants received Dose 1 of the mRNA-1273 vaccine administered into the right arm as an IM injection on Day 1 and Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1. Participants then received Dose 1 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 2 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 8. | 0 | 83 | 0 | 81 | 59 | 81 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Jun 30, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000090983 | 2019-nCoV Vaccine mRNA-1273 |
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Anti-HPV 11 |
|
|
| Anti-HPV 16 |
|
|
| Anti-HPV 18 |
|
|
| Anti-HPV 31 |
|
|
| Anti-HPV 33 |
|
|
| Anti-HPV 45 |
|
|
| Anti-HPV 52 |
|
|
| Anti-HPV 58 |
|
|
| Anti-HPV 11 | Geometric Mean Titer (GMT) Ratio | 1.33 | 2-Sided | 95 | 1.01 | 1.75 | GMT Ratio is between Concomitant Group/Non-concomitant Group. | Other | Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group. |
| Anti-HPV 16 | Geometric Mean Titer (GMT) Ratio | 1.36 | 2-Sided | 95 | 1.02 | 1.82 | GMT Ratio is between Concomitant Group/Non-concomitant Group. | Other | Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group. |
| Anti-HPV 18 | Geometric Mean Titer (GMT) Ratio | 1.25 | 2-Sided | 95 | 0.92 | 1.70 | GMT Ratio is between Concomitant Group/Non-concomitant Group. | Other | Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. Group. GMT Ratio is between Concomitant Group/Non-concomitant Group. |
| Anti-HPV 31 | Geometric Mean Titer (GMT) Ratio | 1.21 | 2-Sided | 95 | 0.91 | 1.61 | GMT Ratio is between Concomitant Group/Non-concomitant Group. | Other | Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. Group. GMT Ratio is between Concomitant Group/Non-concomitant Group. |
| Anti-HPV 33 | Geometric Mean Titer (GMT) Ratio | 1.32 | 2-Sided | 95 | 0.98 | 1.77 | GMT Ratio is between Concomitant Group/Non-concomitant Group. | Other | Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group. |
| Anti-HPV 45 | Geometric Mean Titer (GMT) Ratio | 1.40 | 2-Sided | 95 | 1.01 | 1.93 | GMT Ratio is between Concomitant Group/Non-concomitant Group. | Other | Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group. |
| Anti-HPV 52 | Geometric Mean Titer (GMT) Ratio | 1.45 | 2-Sided | 95 | 1.13 | 1.87 | GMT Ratio is between Concomitant Group/Non-concomitant Group. | Other | Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group. |
| Anti-HPV 58 | Geometric Mean Titer (GMT) Ratio | 1.20 | 2-Sided | 95 | 0.91 | 1.58 | GMT Ratio is between Concomitant Group/Non-concomitant Group. | Other | Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group. |
|
|
|
| OG001 | Non-concomitant Group | Participants received Dose 1 of the mRNA-1273 vaccine administered into the right arm as an IM injection on Day 1 and Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1. Participants then received Dose 1 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 2 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 8. |
|
|
| OG001 | Non-concomitant Group | Participants received Dose 1 of the mRNA-1273 vaccine administered into the right arm as an IM injection on Day 1 and Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1. Participants then received Dose 1 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 2 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 8. |
|
|
| OG001 | Non-concomitant Group | Participants received Dose 1 of the mRNA-1273 vaccine administered into the right arm as an IM injection on Day 1 and Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1. Participants then received Dose 1 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 2 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 8. |
|
|
| OG001 | Non-concomitant Group | Participants received Dose 1 of the mRNA-1273 vaccine administered into the right arm as an IM injection on Day 1 and Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1. Participants then received Dose 1 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 2 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 8. |
|
|
Participants received Dose 1 of 9-valent human papillomavirus [Types 6, 11, 16, 18, 31, 33, 45, 52, 58] (9vHPV) vaccine administered into the left arm as an intramuscular (IM) injection, AND Dose 1 of the messenger ribonucleic acid (mRNA)-1273 vaccine administered into the right arm as an IM injection on Day 1; participants then received Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 6. |
| OG001 | Non-concomitant Group | Participants received Dose 1 of the mRNA-1273 vaccine administered into the right arm as an IM injection on Day 1 and Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1. Participants then received Dose 1 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 2 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 8. |
|
|
| OG001 |
| Non-concomitant Group |
Participants received Dose 1 of the mRNA-1273 vaccine administered into the right arm as an IM injection on Day 1 and Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1. Participants then received Dose 1 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 2 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 8. |
|
|