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Papillomavirus InfectionsPhase 3NCT05119855

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)

A Phase 3 study testing 9vHPV Vaccine and mRNA-1273 Vaccine in people with Papillomavirus Infections and Coronavirus Disease (COVID-19), run by Merck Sharp & Dohme LLC at 38 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 9 to 11 yearsHealthy volunteers can take part
What is being tested?
9vHPV Vaccine and mRNA-1273 Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
38 sitesUnited States
Study dates
28 Mar 2022to 12 Dec 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

United States38 sites

  • Atlanta Center for Medical Research ( Site 0055)

    Atlanta, Georgia, 30331

  • DermResearch, Inc. ( Site 0056)

    Austin, Texas, 78759

  • Coast Clinical Research, LLC ( Site 0027)

    Bellflower, California, 90706

  • WR-ClinSearch ( Site 0049)

    Chattanooga, Tennessee, 37421

  • South Texas Clinical Research ( Site 0024)

    Corpus Christi, Texas, 78404

  • Certified Research Associates ( Site 0090)

    Cortland, New York, 13045

  • Dayton Clinical Research ( Site 0028)

    Dayton, Ohio, 45409

  • South Texas Pediatric Research Group ( Site 0094)

    Del Rio, Texas, 78840

  • Accel Research Sites-DeLand Clinical Research Unit ( Site 0066)

    DeLand, Florida, 32720

  • Carolina Institute for Clinical Research, LLC ( Site 0042)

    Fayetteville, North Carolina, 28303

  • CBH Health ( Site 0019)

    Gaithersburg, Maryland, 20877

  • Corning Center for Clinical Research ( Site 0091)

    Horseheads, New York, 14845

  • West Houston Clinical Research Services ( Site 0078)

    Houston, Texas, 77055

  • Next Level Urgent Care, LLC ( Site 0099)

    Houston, Texas, 77057

  • Clinical Research Prime ( Site 0088)

    Idaho Falls, Idaho, 83404

  • Advanced Research for Health Improvement, LLC ( Site 0012)

    Immokalee, Florida, 34142

  • Children's Clinic of Jonesboro, PA ( Site 0044)

    Jonesboro, Arkansas, 72401

  • Milton Haber, M.D. ( Site 0069)

    Laredo, Texas, 78041

  • University of Texas Medical Branch ( Site 0026)

    League City, Texas, 77573

  • Midwest Children's Health Research Institute ( Site 0003)

    Lincoln, Nebraska, 68505

  • Preferred Research Partners Inc. ( Site 0092)

    Little Rock, Arkansas, 72211

  • Ark Clinical Research ( Site 0098)

    Long Beach, California, 90815

  • Acevedo Clinical Research Associates ( Site 0001)

    Miami, Florida, 33142

  • Alpha Science Research ( Site 0067)

    Miami, Florida, 33186

  • Advanced Research For Health Improvement LLC ( Site 0075)

    Naples, Florida, 34102

  • Valley Clinical Trials Inc. ( Site 0004)

    Northridge, California, 91325

  • Thomas Jefferson University - Family and Community Medicine ( Site 0006)

    Philadelphia, Pennsylvania, 19107

  • Cognitive Clinical Trials, LLC ( Site 0054)

    Phoenix, Arizona, 85044

  • M3 Wake Research, Inc. ( Site 0014)

    Raleigh, North Carolina, 27612

  • SKY Integrative Medical Center/SKYCRNG ( Site 0084)

    Ridgeland, Mississippi, 39157

  • University of Utah ( Site 0076)

    Salt Lake City, Utah, 84132

  • Medical Center for Clinical Research ( Site 0051)

    San Diego, California, 92120

  • Mount Vernon Clinical Research ( Site 0053)

    Sandy Springs, Georgia, 30328

  • Eclipse Clinical Research ( Site 0095)

    Tucson, Arizona, 85745

  • Ark Clinical Research ( Site 0108)

    Tustin, California, 92780

  • Emerson Clinical Research Institute ( Site 0021)

    Washington D.C., District of Columbia, 20011

  • Velocity Clinical Research, Salt Lake City ( Site 0025)

    West Jordan, Utah, 84088

  • Comprehensive Clinical Research ( Site 0038)

    West Palm Beach, Florida, 33409

Other trials in United States

About this study

Official title: A Phase 3, Multicenter, Open-Label Study to Evaluate the Safety and Immunogenicity of 2-dose Regimens of 9vHPV and mRNA-1273 SARS-CoV-2 Vaccines Where the First Dose of Each Vaccine Are Given Concomitantly in Boys and Girls 9 to 11 Years of Age

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.

Being tested
9vHPV Vaccine, mRNA-1273 Vaccine
Medical subject headings
Papillomavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 9vHPV VaccineBiological

    Also called V503, GARDASIL®9, SILGARD®9

    9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular (IM) injection

  • mRNA-1273 VaccineBiological

    Also called SARS-CoV-2 Vaccine, Moderna COVID-19 Vaccine

    mRNA-1273 50 mcg dose administered as a 0.25-mL IM injection

Study groups in NCT05119855
Study groupRoleWhat they receive
Concomitant GroupExperimentalParticipants 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.
Receives: Biological: 9vHPV Vaccine; Biological: mRNA-1273 Vaccine
Non-concomitant GroupExperimentalParticipants 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.
Receives: Biological: 9vHPV Vaccine; Biological: mRNA-1273 Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up approximately 4 weeks post vaccination with 9vHPV Dose 2

  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.

    Measured: Up approximately 4 weeks post vaccination with mRNA-1273 Dose 2

  3. 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.

    Measured: Up to approximately Day 7 post vaccination with any study vaccine

  4. 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.

    Measured: Up to approximately Day 7 post vaccination with any study vaccine

  5. 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.

    Measured: Up to approximately Day 28 post vaccination with any study vaccine

  6. 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.

    Measured: Up to approximately 9 Months

Secondary outcomes (2)

  1. 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.

    Measured: Up to approximately 4 weeks post vaccination with 9vHPV Dose 2

  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.

    Measured: Up to approximately 4 weeks post vaccination with mRNA-1273 Dose 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2021
  2. Study start28 Mar 2022
  3. Primary completion12 Dec 2023
  4. Study completion12 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05119855
Sponsor's protocol ID
V503-076
Other IDs
2021-003591-13
Status last verified
Dec 2025
First submitted
10 Nov 2021
Last updated
5 Feb 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 9vHPV Vaccine and mRNA-1273 Vaccine in people with Papillomavirus Infections and Coronavirus Disease (COVID-19), run by Merck Sharp & Dohme LLC at 38 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV) (time frame: Up approximately 4 weeks post vaccination with 9vHPV Dose 2). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05119855.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.

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