Trial Outcomes & Findings for Safety and Immunogenicity of 9-valent Human Papillomavirus (9vHPV) Vaccine Coadministered With Messenger Ribonucleic Acid (mRNA)-1273 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (COVID-19) Vaccine (V503-076) (NCT NCT05119855)

NCT ID: NCT05119855

Last Updated: 2026-02-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

165 participants

Primary outcome timeframe

Up approximately 4 weeks post vaccination with 9vHPV Dose 2

Results posted on

2026-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	82	83
Overall Study Vaccinated: mRNA-1273 Dose 1	81	81
Overall Study Vaccinated: 9vHPV Dose 1	81	72
Overall Study Vaccinated: mRNA-1273 Dose 2	78	78
Overall Study Vaccinated: 9vHPV Dose 2	67	66
Overall Study Concomitant Group Dose 1 Day 1: 9vHPV	81	0
Overall Study Concomitant Group Dose 1 Day 1: mRNA-1273	81	0
Overall Study Concomitant Group Dose 2 Month 1: mRNA-1273	78	0
Overall Study Concomitant Group Dose 2 Month 6: 9vHPV	67	0
Overall Study Non-concomitant Group Dose 1 Day 1: mRNA-1273	0	81
Overall Study Non-concomitant Group Dose 2 Month 1: mRNA-1273	0	78
Overall Study Non-concomitant Group Dose 1 Month 2: 9vHPV	0	72
Overall Study Non-concomitant Group Dose 2 Month 8: 9vHPV	0	66
Overall Study COMPLETED	66	64
Overall Study NOT COMPLETED	16	19

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Randomized by Mistake Without Study Treatment	0	1
Overall Study Withdrawal By Parent/Guardian	10	10
Overall Study Lost to Follow-up	6	8

Baseline Characteristics

Safety and Immunogenicity of 9-valent Human Papillomavirus (9vHPV) Vaccine Coadministered With Messenger Ribonucleic Acid (mRNA)-1273 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (COVID-19) Vaccine (V503-076)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-concomitant Group n=83 Participants 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.	Total n=165 Participants Total of all reporting groups	Concomitant Group n=82 Participants 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.
Age, Continuous	9.9 Years STANDARD_DEVIATION 0.8 • n=26 Participants	9.9 Years STANDARD_DEVIATION 0.8 • n=51 Participants	9.9 Years STANDARD_DEVIATION 0.9 • n=25 Participants
Sex: Female, Male Female	45 Participants n=26 Participants	88 Participants n=51 Participants	43 Participants n=25 Participants
Sex: Female, Male Male	38 Participants n=26 Participants	77 Participants n=51 Participants	39 Participants n=25 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	46 Participants n=26 Participants	96 Participants n=51 Participants	50 Participants n=25 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=26 Participants	69 Participants n=51 Participants	32 Participants n=25 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=26 Participants	0 Participants n=51 Participants	0 Participants n=25 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=26 Participants	0 Participants n=51 Participants	0 Participants n=25 Participants
Race (NIH/OMB) Asian	0 Participants n=26 Participants	1 Participants n=51 Participants	1 Participants n=25 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=26 Participants	0 Participants n=51 Participants	0 Participants n=25 Participants
Race (NIH/OMB) Black or African American	31 Participants n=26 Participants	59 Participants n=51 Participants	28 Participants n=25 Participants
Race (NIH/OMB) White	48 Participants n=26 Participants	101 Participants n=51 Participants	53 Participants n=25 Participants
Race (NIH/OMB) More than one race	2 Participants n=26 Participants	2 Participants n=51 Participants	0 Participants n=25 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=26 Participants	2 Participants n=51 Participants	0 Participants n=25 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Non-concomitant Group n=49 Participants 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.	Concomitant Group n=51 Participants 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.
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 Interval 750.3 to 1110.0	1095.2 mMU/mL Interval 900.5 to 1332.1
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 Interval 1481.8 to 2202.9	2198.5 mMU/mL Interval 1806.9 to 2674.8
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 Interval 941.4 to 1376.2	1517.6 mMU/mL Interval 1247.5 to 1846.2
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 Interval 5728.2 to 8657.7	9595.8 mMU/mL Interval 7822.5 to 11771.0
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 Interval 1372.1 to 2139.1	2139.2 mMU/mL Interval 1721.3 to 2658.6
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 Interval 1149.0 to 1717.2	1695.6 mMU/mL Interval 1383.9 to 2077.3
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 Interval 720.2 to 1099.6	1172.3 mMU/mL Interval 950.8 to 1445.5
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 Interval 293.6 to 468.4	518.0 mMU/mL Interval 413.0 to 649.6
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 Interval 421.9 to 603.7	733.6 mMU/mL Interval 614.4 to 875.9

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Non-concomitant Group n=60 Participants 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.	Concomitant Group n=56 Participants 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.
Geometric Mean Concentrations of SARS-CoV-2 Spike Protein-Specific Binding Antibodies	650527.9 μg/mL Interval 576365.9 to 734232.5	763084.3 μg/mL Interval 673224.4 to 864938.4

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Non-concomitant Group n=81 Participants 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.	Concomitant Group n=81 Participants 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.
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
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
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
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
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	—
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	—
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	—
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Non-concomitant Group n=81 Participants 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.	Concomitant Group n=81 Participants 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.
Percentage of Participants With ≥1 Solicited Systemic AE Concomitant Group: Day 1 - 9vHPV Dose 1 + mRNA-1273 Dose 1	—	33.3 Percentage of Participants
Percentage of Participants With ≥1 Solicited Systemic AE Concomitant Group: Month 1 - mRNA-1273 Dose 2	—	33.3 Percentage of Participants
Percentage of Participants With ≥1 Solicited Systemic AE Concomitant Group: Month 6 - 9vHPV Dose 2	—	17.9 Percentage of Participants
Percentage of Participants With ≥1 Solicited Systemic AE Non-concomitant Group: Day 1 - mRNA-1273 Dose 1	37.0 Percentage of Participants	—
Percentage of Participants With ≥1 Solicited Systemic AE Non-concomitant Group: Month 1 - mRNA-1273 Dose 2	33.3 Percentage of Participants	—
Percentage of Participants With ≥1 Solicited Systemic AE Non-concomitant Group: Month 2 - 9vHPV Dose 1	16.7 Percentage of Participants	—
Percentage of Participants With ≥1 Solicited Systemic AE Non-concomitant Group: Month 8 - 9vHPV Dose 2	10.6 Percentage of Participants	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Non-concomitant Group n=81 Participants 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.	Concomitant Group n=81 Participants 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.
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
Percentage of Participants With ≥1 Serious Adverse Event (SAE) Concomitant Group: Month 1 - mRNA-1273 Dose 2	—	0.0 Percentage of Participants
Percentage of Participants With ≥1 Serious Adverse Event (SAE) Concomitant Group: Month 6 - 9vHPV Dose 2	—	0.0 Percentage of Participants
Percentage of Participants With ≥1 Serious Adverse Event (SAE) Non-concomitant Group: Day 1 - mRNA-1273 Dose 1	0.0 Percentage of Participants	—
Percentage of Participants With ≥1 Serious Adverse Event (SAE) Non-concomitant Group: Month 1 - mRNA-1273 Dose 2	0.0 Percentage of Participants	—
Percentage of Participants With ≥1 Serious Adverse Event (SAE) Non-concomitant Group: Month 2 - 9vHPV Dose 1	0.0 Percentage of Participants	—
Percentage of Participants With ≥1 Serious Adverse Event (SAE) Non-concomitant Group: Month 8 - 9vHPV Dose 2	0.0 Percentage of Participants	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Non-concomitant Group n=81 Participants 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.	Concomitant Group n=81 Participants 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.
Percentage of Participants With ≥1 Vaccine-Related SAE Concomitant Group: Day 1 - 9vHPV Dose 1 + mRNA-1273 Dose 1	—	0.0 Percentage of Participants
Percentage of Participants With ≥1 Vaccine-Related SAE Concomitant Group: Month 1 - mRNA-1273 Dose 2	—	0.0 Percentage of Participants
Percentage of Participants With ≥1 Vaccine-Related SAE Concomitant Group: Month 6 - 9vHPV Dose 2	—	0.0 Percentage of Participants
Percentage of Participants With ≥1 Vaccine-Related SAE Non-concomitant Group: Day 1 - mRNA-1273 Dose 1	0.0 Percentage of Participants	—
Percentage of Participants With ≥1 Vaccine-Related SAE Non-concomitant Group: Month 1 - mRNA-1273 Dose 2	0.0 Percentage of Participants	—
Percentage of Participants With ≥1 Vaccine-Related SAE Non-concomitant Group: Month 2 - 9vHPV Dose 1	0.0 Percentage of Participants	—
Percentage of Participants With ≥1 Vaccine-Related SAE Non-concomitant Group: Month 8 - 9vHPV Dose 2	0.0 Percentage of Participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Non-concomitant Group n=49 Participants 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.	Concomitant Group n=51 Participants 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.
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 Interval 92.3 to 100.0	100.0 Percentage of Participants Interval 92.5 to 100.0
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 Interval 92.7 to 100.0	100.0 Percentage of Participants Interval 92.3 to 100.0
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 Interval 92.3 to 100.0	100.0 Percentage of Participants Interval 92.5 to 100.0
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 Interval 92.3 to 100.0	100.0 Percentage of Participants Interval 92.6 to 100.0
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 Interval 92.5 to 100.0	100.0 Percentage of Participants Interval 92.3 to 100.0
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 Interval 92.5 to 100.0	100.0 Percentage of Participants Interval 92.6 to 100.0
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 Interval 92.5 to 100.0	100.0 Percentage of Participants Interval 92.9 to 100.0
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 Interval 92.6 to 100.0	100.0 Percentage of Participants Interval 92.7 to 100.0
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 Interval 92.6 to 100.0	100.0 Percentage of Participants Interval 92.6 to 100.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Non-concomitant Group n=60 Participants 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.	Concomitant Group n=56 Participants 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.
Percentage of Participants Who Experience Seroresponse Following Administration of a 2-Dose Regimen of mRNA-1273 Vaccine	95.0 Percentage of Participants Interval 86.1 to 99.0	96.4 Percentage of Participants Interval 87.7 to 99.6

Adverse Events

Non-concomitant Group

Serious events: 0 serious events

Other events: 59 other events

Deaths: 0 deaths

Concomitant Group

Serious events: 0 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Non-concomitant Group n=81 participants at risk 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.	Concomitant Group n=81 participants at risk 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.
General disorders Chills	13.6% 11/81 • Number of events 11 • 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.	16.0% 13/81 • Number of events 16 • 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.
Blood and lymphatic system disorders Lymphadenopathy	24.7% 20/81 • Number of events 25 • 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.	7.4% 6/81 • Number of events 6 • 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.
Gastrointestinal disorders Nausea	6.2% 5/81 • Number of events 7 • 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.	11.1% 9/81 • Number of events 10 • 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.
General disorders Fatigue	28.4% 23/81 • Number of events 38 • 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.	28.4% 23/81 • Number of events 32 • 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.
General disorders Injection site erythema	14.8% 12/81 • Number of events 18 • 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.	7.4% 6/81 • Number of events 7 • 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.
General disorders Injection site pain	64.2% 52/81 • Number of events 122 • 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.	56.8% 46/81 • Number of events 113 • 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.
General disorders Injection site swelling	22.2% 18/81 • Number of events 27 • 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.	17.3% 14/81 • Number of events 22 • 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.
General disorders Pyrexia	12.3% 10/81 • Number of events 14 • 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.	13.6% 11/81 • Number of events 15 • 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.
Musculoskeletal and connective tissue disorders Arthralgia	12.3% 10/81 • Number of events 11 • 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.	8.6% 7/81 • Number of events 7 • 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.
Musculoskeletal and connective tissue disorders Myalgia	19.8% 16/81 • Number of events 19 • 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.	11.1% 9/81 • Number of events 12 • 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.
Nervous system disorders Headache	37.0% 30/81 • Number of events 46 • 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.	32.1% 26/81 • Number of events 33 • 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.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER