Coronavirus Disease (COVID-19), Papillomavirus Infections
Conditions
Brief summary
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.
Interventions
BIOLOGICAL9vHPV Vaccine
9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular (IM) injection
BIOLOGICALmRNA-1273 Vaccine
mRNA-1273 50 mcg dose administered as a 0.25-mL IM injection
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* Has not yet had coitarche and does not plan on becoming sexually active during the vaccination period * Participant or participant's legally acceptable representative can read, understand, and complete the electronic vaccination report card (eVRC).
Exclusion criteria
* Known allergy to any vaccine component * History of severe allergic reaction that required medical intervention * Thrombocytopenia or any coagulation disorder * Has a history of myocarditis or pericarditis * Has a history of a clinical or microbiological diagnosis of COVID-19 ≤90 days prior to Day 1 visit or history of multisystem inflammatory syndrome in children (MIS-C) at any time prior to Day 1 visit * Females only: participant is pregnant * Currently immunocompromised, or been diagnosed with immunodeficiency * Had a splenectomy * Receiving or has received immunosuppressive therapies within the last year * Received any immunoglobulin product or blood-derived product within 3 months * Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) | Up approximately 4 weeks post vaccination with 9vHPV Dose 2 | 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. |
| Geometric Mean Concentrations of SARS-CoV-2 Spike Protein-Specific Binding Antibodies | Up approximately 4 weeks post vaccination with mRNA-1273 Dose 2 | 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. |
| Percentage of Participants With ≥1 Solicited Injection-site Adverse Event (AE) | Up to approximately Day 7 post vaccination with any study vaccine | 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. |
| Percentage of Participants With ≥1 Solicited Systemic AE | Up to approximately Day 7 post vaccination with any study vaccine | 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. |
| Percentage of Participants With ≥1 Serious Adverse Event (SAE) | Up to approximately Day 28 post vaccination with any study vaccine | 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. |
| Percentage of Participants With ≥1 Vaccine-Related SAE | Up to approximately 9 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to approximately 4 weeks post vaccination with 9vHPV Dose 2 | 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. |
| Percentage of Participants Who Experience Seroresponse Following Administration of a 2-Dose Regimen of mRNA-1273 Vaccine | Up to approximately 4 weeks post vaccination with mRNA-1273 Dose 2 | 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. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 82 |
| 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. | 83 |
| Total | 165 |
Baseline characteristics
| Characteristic | Concomitant Group | Total | Non-concomitant Group |
|---|---|---|---|
| Age, Continuous | 9.9 Years STANDARD_DEVIATION 0.9 | 9.9 Years STANDARD_DEVIATION 0.8 | 9.9 Years STANDARD_DEVIATION 0.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 50 Participants | 96 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 69 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants | 59 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 53 Participants | 101 Participants | 48 Participants |
| Sex: Female, Male Female | 43 Participants | 88 Participants | 45 Participants |
| Sex: Female, Male Male | 39 Participants | 77 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 82 | 0 / 83 |
| other Total, other adverse events | 55 / 81 | 59 / 81 |
| serious Total, serious adverse events | 0 / 81 | 0 / 81 |
Outcome results
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.
Time frame: Up approximately 4 weeks post vaccination with mRNA-1273 Dose 2
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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Concomitant Group | Geometric Mean Concentrations of SARS-CoV-2 Spike Protein-Specific Binding Antibodies | 763084.3 μg/mL |
| Non-concomitant Group | Geometric Mean Concentrations of SARS-CoV-2 Spike Protein-Specific Binding Antibodies | 650527.9 μg/mL |
Comparison: Geometric Mean Concentration (GMC) Ratio95% CI: [0.99, 1.4]
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.
Time frame: Up approximately 4 weeks post vaccination with 9vHPV Dose 2
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Concomitant Group | Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) | Anti-HPV 31 | 1695.6 mMU/mL |
| Concomitant Group | Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) | Anti-HPV 16 | 9595.8 mMU/mL |
| Concomitant Group | Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) | Anti-HPV 33 | 1172.3 mMU/mL |
| Concomitant Group | Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) | Anti-HPV 11 | 1517.6 mMU/mL |
| Concomitant Group | Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) | Anti-HPV 45 | 518.0 mMU/mL |
| Concomitant Group | Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) | Anti-HPV 18 | 2139.2 mMU/mL |
| Concomitant Group | Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) | Anti-HPV 52 | 733.6 mMU/mL |
| Concomitant Group | Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) | Anti-HPV 58 | 1095.2 mMU/mL |
| Concomitant Group | Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) | Anti-HPV 6 | 2198.5 mMU/mL |
| Non-concomitant Group | Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) | Anti-HPV 58 | 912.6 mMU/mL |
| Non-concomitant Group | Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) | Anti-HPV 6 | 1806.8 mMU/mL |
| Non-concomitant Group | Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) | Anti-HPV 11 | 1138.2 mMU/mL |
| Non-concomitant Group | Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) | Anti-HPV 16 | 7042.3 mMU/mL |
| Non-concomitant Group | Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) | Anti-HPV 18 | 1713.2 mMU/mL |
| Non-concomitant Group | Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) | Anti-HPV 31 | 1404.7 mMU/mL |
| Non-concomitant Group | Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) | Anti-HPV 33 | 889.9 mMU/mL |
| Non-concomitant Group | Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) | Anti-HPV 45 | 370.8 mMU/mL |
| Non-concomitant Group | Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) | Anti-HPV 52 | 504.7 mMU/mL |
Comparison: Anti-HPV 695% CI: [0.92, 1.61]
Comparison: Anti-HPV 1195% CI: [1.01, 1.75]
Comparison: Anti-HPV 1695% CI: [1.02, 1.82]
Comparison: Anti-HPV 1895% CI: [0.92, 1.7]
Comparison: Anti-HPV 3195% CI: [0.91, 1.61]
Comparison: Anti-HPV 3395% CI: [0.98, 1.77]
Comparison: Anti-HPV 4595% CI: [1.01, 1.93]
Comparison: Anti-HPV 5295% CI: [1.13, 1.87]
Comparison: Anti-HPV 5895% CI: [0.91, 1.58]
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.
Time frame: Up to approximately Day 28 post vaccination with any study vaccine
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Concomitant Group | Percentage of Participants With ≥1 Serious Adverse Event (SAE) | Concomitant Group: Day 1 - 9vHPV Dose 1 + mRNA-1273 Dose 1 | 0.0 Percentage of Participants |
| Concomitant Group | Percentage of Participants With ≥1 Serious Adverse Event (SAE) | Concomitant Group: Month 1 - mRNA-1273 Dose 2 | 0.0 Percentage of Participants |
| Concomitant Group | Percentage of Participants With ≥1 Serious Adverse Event (SAE) | Concomitant Group: Month 6 - 9vHPV Dose 2 | 0.0 Percentage of Participants |
| Non-concomitant Group | Percentage of Participants With ≥1 Serious Adverse Event (SAE) | Non-concomitant Group: Day 1 - mRNA-1273 Dose 1 | 0.0 Percentage of Participants |
| Non-concomitant Group | Percentage of Participants With ≥1 Serious Adverse Event (SAE) | Non-concomitant Group: Month 1 - mRNA-1273 Dose 2 | 0.0 Percentage of Participants |
| Non-concomitant Group | Percentage of Participants With ≥1 Serious Adverse Event (SAE) | Non-concomitant Group: Month 2 - 9vHPV Dose 1 | 0.0 Percentage of Participants |
| Non-concomitant Group | Percentage of Participants With ≥1 Serious Adverse Event (SAE) | Non-concomitant Group: Month 8 - 9vHPV Dose 2 | 0.0 Percentage of Participants |
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.
Time frame: Up to approximately Day 7 post vaccination with any study vaccine
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Concomitant Group | Percentage of Participants With ≥1 Solicited Injection-site Adverse Event (AE) | Concomitant Group: Day 1 -mRNA-1273 Dose 1 (right arm) | 49.4 Percentage of Participants |
| Concomitant Group | Percentage of Participants With ≥1 Solicited Injection-site Adverse Event (AE) | Concomitant Group: Day 1 - 9vHPV Dose 1 (left arm) | 39.5 Percentage of Participants |
| Concomitant Group | Percentage of Participants With ≥1 Solicited Injection-site Adverse Event (AE) | Concomitant Group: Month 1 - mRNA-1273 Dose 2 (right arm) | 35.9 Percentage of Participants |
| Concomitant Group | Percentage of Participants With ≥1 Solicited Injection-site Adverse Event (AE) | Concomitant Group: Month 6 - 9vHPV Dose 2 (left arm) | 26.9 Percentage of Participants |
| Non-concomitant Group | Percentage of Participants With ≥1 Solicited Injection-site Adverse Event (AE) | Non-concomitant Group: Day 1 - mRNA-1273 Dose 1 (right arm) | 55.6 Percentage of Participants |
| Non-concomitant Group | Percentage of Participants With ≥1 Solicited Injection-site Adverse Event (AE) | Non-concomitant Group: Month 1 -mRNA-1273 Dose 2 (right arm) | 44.9 Percentage of Participants |
| Non-concomitant Group | Percentage of Participants With ≥1 Solicited Injection-site Adverse Event (AE) | Non-Concomitant Group: Month 2 - 9vHPV Dose 1 (left arm) | 29.2 Percentage of Participants |
| Non-concomitant Group | Percentage of Participants With ≥1 Solicited Injection-site Adverse Event (AE) | Non-concomitant Group: Month 8 - 9vHPV Dose 2 (left arm) | 43.9 Percentage of Participants |
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.
Time frame: Up to approximately Day 7 post vaccination with any study vaccine
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Concomitant Group | Percentage of Participants With ≥1 Solicited Systemic AE | Concomitant Group: Day 1 - 9vHPV Dose 1 + mRNA-1273 Dose 1 | 33.3 Percentage of Participants |
| Concomitant Group | Percentage of Participants With ≥1 Solicited Systemic AE | Concomitant Group: Month 1 - mRNA-1273 Dose 2 | 33.3 Percentage of Participants |
| Concomitant Group | Percentage of Participants With ≥1 Solicited Systemic AE | Concomitant Group: Month 6 - 9vHPV Dose 2 | 17.9 Percentage of Participants |
| Non-concomitant Group | Percentage of Participants With ≥1 Solicited Systemic AE | Non-concomitant Group: Day 1 - mRNA-1273 Dose 1 | 37.0 Percentage of Participants |
| Non-concomitant Group | Percentage of Participants With ≥1 Solicited Systemic AE | Non-concomitant Group: Month 1 - mRNA-1273 Dose 2 | 33.3 Percentage of Participants |
| Non-concomitant Group | Percentage of Participants With ≥1 Solicited Systemic AE | Non-concomitant Group: Month 2 - 9vHPV Dose 1 | 16.7 Percentage of Participants |
| Non-concomitant Group | Percentage of Participants With ≥1 Solicited Systemic AE | Non-concomitant Group: Month 8 - 9vHPV Dose 2 | 10.6 Percentage of Participants |
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.
Time frame: Up to approximately 9 Months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Concomitant Group | Percentage of Participants With ≥1 Vaccine-Related SAE | Concomitant Group: Day 1 - 9vHPV Dose 1 + mRNA-1273 Dose 1 | 0.0 Percentage of Participants |
| Concomitant Group | Percentage of Participants With ≥1 Vaccine-Related SAE | Concomitant Group: Month 1 - mRNA-1273 Dose 2 | 0.0 Percentage of Participants |
| Concomitant Group | Percentage of Participants With ≥1 Vaccine-Related SAE | Concomitant Group: Month 6 - 9vHPV Dose 2 | 0.0 Percentage of Participants |
| Non-concomitant Group | Percentage of Participants With ≥1 Vaccine-Related SAE | Non-concomitant Group: Day 1 - mRNA-1273 Dose 1 | 0.0 Percentage of Participants |
| Non-concomitant Group | Percentage of Participants With ≥1 Vaccine-Related SAE | Non-concomitant Group: Month 1 - mRNA-1273 Dose 2 | 0.0 Percentage of Participants |
| Non-concomitant Group | Percentage of Participants With ≥1 Vaccine-Related SAE | Non-concomitant Group: Month 2 - 9vHPV Dose 1 | 0.0 Percentage of Participants |
| Non-concomitant Group | Percentage of Participants With ≥1 Vaccine-Related SAE | Non-concomitant Group: Month 8 - 9vHPV Dose 2 | 0.0 Percentage of Participants |
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.
Time frame: Up to approximately 4 weeks post vaccination with mRNA-1273 Dose 2
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Concomitant Group | Percentage of Participants Who Experience Seroresponse Following Administration of a 2-Dose Regimen of mRNA-1273 Vaccine | 96.4 Percentage of Participants |
| Non-concomitant Group | Percentage of Participants Who Experience Seroresponse Following Administration of a 2-Dose Regimen of mRNA-1273 Vaccine | 95.0 Percentage of Participants |
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.
Time frame: Up to approximately 4 weeks post vaccination with 9vHPV Dose 2
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Concomitant Group | 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 | Anti-HPV 11 cLIA ≥25 mMU/ mL | 100.0 Percentage of Participants |
| Concomitant Group | 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 | Anti-HPV 33 cLIA ≥10 mMU/ mL | 100.0 Percentage of Participants |
| Concomitant Group | 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 | Anti-HPV 18 cLIA ≥26 mMU/ mL | 100.0 Percentage of Participants |
| Concomitant Group | 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 | Anti-HPV 45 cLIA ≥10 mMU/ mL | 100.0 Percentage of Participants |
| Concomitant Group | 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 | Anti-HPV 16 cLIA ≥32 mMU/ mL | 100.0 Percentage of Participants |
| Concomitant Group | 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 | Anti-HPV 52 cLIA ≥14 mMU/ mL | 100.0 Percentage of Participants |
| Concomitant Group | 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 | Anti-HPV 31 cLIA ≥15 mMU/ mL | 100.0 Percentage of Participants |
| Concomitant Group | 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 | Anti-HPV 58 cLIA ≥10 mMU/ mL | 100.0 Percentage of Participants |
| Concomitant Group | 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 | Anti-HPV 6 cLIA ≥34 mMU/ mL | 100.0 Percentage of Participants |
| Non-concomitant Group | 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 | Anti-HPV 58 cLIA ≥10 mMU/ mL | 100.0 Percentage of Participants |
| Non-concomitant Group | 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 | Anti-HPV 6 cLIA ≥34 mMU/ mL | 100.0 Percentage of Participants |
| Non-concomitant Group | 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 | Anti-HPV 11 cLIA ≥25 mMU/ mL | 100.0 Percentage of Participants |
| Non-concomitant Group | 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 | Anti-HPV 16 cLIA ≥32 mMU/ mL | 100.0 Percentage of Participants |
| Non-concomitant Group | 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 | Anti-HPV 18 cLIA ≥26 mMU/ mL | 100.0 Percentage of Participants |
| Non-concomitant Group | 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 | Anti-HPV 31 cLIA ≥15 mMU/ mL | 100.0 Percentage of Participants |
| Non-concomitant Group | 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 | Anti-HPV 33 cLIA ≥10 mMU/ mL | 100.0 Percentage of Participants |
| Non-concomitant Group | 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 | Anti-HPV 45 cLIA ≥10 mMU/ mL | 100.0 Percentage of Participants |
| Non-concomitant Group | 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 | Anti-HPV 52 cLIA ≥14 mMU/ mL | 100.0 Percentage of Participants |