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, 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.

Study Overview

• Status: Completed
• Conditions: Papillomavirus Infections; Coronavirus Disease (COVID-19)
• Intervention / Treatment: Biological: 9vHPV Vaccine; Biological: mRNA-1273 Vaccine

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85044
      • Cognitive Clinical Trials, LLC ( Site 0054)
    • Tucson, Arizona, United States, 85745
      • Eclipse Clinical Research ( Site 0095)
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Children's Clinic of Jonesboro, PA ( Site 0044)
    • Little Rock, Arkansas, United States, 72211
      • Preferred Research Partners Inc. ( Site 0092)
  • California
    • Bellflower, California, United States, 90706
      • Coast Clinical Research, LLC ( Site 0027)
    • Long Beach, California, United States, 90815
      • Ark Clinical Research ( Site 0098)
    • Northridge, California, United States, 91325
      • Valley Clinical Trials Inc. ( Site 0004)
    • San Diego, California, United States, 92120
      • Medical Center for Clinical Research ( Site 0051)
    • Tustin, California, United States, 92780
      • Ark Clinical Research ( Site 0108)
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20011
      • Emerson Clinical Research Institute ( Site 0021)
  • Florida
    • DeLand, Florida, United States, 32720
      • Accel Research Sites-DeLand Clinical Research Unit ( Site 0066)
    • Immokalee, Florida, United States, 34142
      • Advanced Research for Health Improvement, LLC ( Site 0012)
    • Miami, Florida, United States, 33142
      • Acevedo Clinical Research Associates ( Site 0001)
    • Miami, Florida, United States, 33186
      • Alpha Science Research ( Site 0067)
    • Naples, Florida, United States, 34102
      • Advanced Research For Health Improvement LLC ( Site 0075)
    • West Palm Beach, Florida, United States, 33409
      • Comprehensive Clinical Research ( Site 0038)
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research ( Site 0055)
    • Sandy Springs, Georgia, United States, 30328
      • Mount Vernon Clinical Research ( Site 0053)
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Clinical Research Prime ( Site 0088)
  • Maryland
    • Gaithersburg, Maryland, United States, 20877
      • CBH Health ( Site 0019)
  • Mississippi
    • Ridgeland, Mississippi, United States, 39157
      • SKY Integrative Medical Center/SKYCRNG ( Site 0084)
  • Nebraska
    • Lincoln, Nebraska, United States, 68505
      • Midwest Children's Health Research Institute ( Site 0003)
  • New York
    • Cortland, New York, United States, 13045
      • Certified Research Associates ( Site 0090)
    • Horseheads, New York, United States, 14845
      • Corning Center for Clinical Research ( Site 0091)
  • North Carolina
    • Fayetteville, North Carolina, United States, 28303
      • Carolina Institute for Clinical Research, LLC ( Site 0042)
    • Raleigh, North Carolina, United States, 27612
      • M3 Wake Research, Inc. ( Site 0014)
  • Ohio
    • Dayton, Ohio, United States, 45409
      • Dayton Clinical Research ( Site 0028)
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University - Family and Community Medicine ( Site 0006)
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • WR-ClinSearch ( Site 0049)
  • Texas
    • Austin, Texas, United States, 78759
      • DermResearch, Inc. ( Site 0056)
    • Corpus Christi, Texas, United States, 78404
      • South Texas Clinical Research ( Site 0024)
    • Del Rio, Texas, United States, 78840
      • South Texas Pediatric Research Group ( Site 0094)
    • Houston, Texas, United States, 77055
      • West Houston Clinical Research Services ( Site 0078)
    • Houston, Texas, United States, 77057
      • Next Level Urgent Care, LLC ( Site 0099)
    • Laredo, Texas, United States, 78041
      • Milton Haber, M.D. ( Site 0069)
    • League City, Texas, United States, 77573
      • University of Texas Medical Branch ( Site 0026)
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah ( Site 0076)
    • West Jordan, Utah, United States, 84088
      • Velocity Clinical Research, Salt Lake City ( Site 0025)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Concomitant Group; Participants will receive Dose 1 of 9-valent human papillomavirus [Types 6, 11, 16, 18, 31, 33, 45, 52, 58] (9vHPV) vaccine administered into the left arm as an intramuscular (IM) injection, AND Dose 1 of the messenger ribonucleic acid (mRNA)-1273 vaccine administered into the right arm as an IM injection on Day 1; participants will then receive Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 6.	Biological: 9vHPV Vaccine; 9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular (IM) injection; Other Names: GARDASIL®9; V503; SILGARD®9; Biological: mRNA-1273 Vaccine; mRNA-1273 50 mcg dose administered as a 0.25-mL IM injection; Other Names: Moderna COVID-19 Vaccine; SARS-CoV-2 Vaccine
Experimental: Non-concomitant Group; Participants will receive Dose 1 of the mRNA-1273 vaccine administered into the right arm as an IM injection on Day 1 and Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1. Participants will then receive Dose 1 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 2 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 8.	Biological: 9vHPV Vaccine; 9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular (IM) injection; Other Names: GARDASIL®9; V503; SILGARD®9; Biological: mRNA-1273 Vaccine; mRNA-1273 50 mcg dose administered as a 0.25-mL IM injection; Other Names: Moderna COVID-19 Vaccine; SARS-CoV-2 Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titers of Anti-Human Papillomavirus Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 (9vHPV)	Antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured using a competitive Luminex immunoassay (cLIA). Per protocol, antibody titers were expressed as milli Merck units/milliliter (mMU/mL). Geometric Mean Titers (GMTs) are reported for both arms for all randomized participants included in the per-protocol immunogenicity (PPI) population. The PPI population is HPV-type specific.	Up approximately 4 weeks post vaccination with 9vHPV Dose 2
Geometric Mean Concentrations of SARS-CoV-2 Spike Protein-Specific Binding Antibodies	The geometric mean concentration (GMC) of serum-derived antibodies to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike protein was determined using an electrochemiluminescence (ECL) assay. GMCs are reported for both arms for all randomized participants included in the mRNA-1273 per-protocol (mRNA-1273-PP) population.	Up approximately 4 weeks post vaccination with mRNA-1273 Dose 2
Percentage of Participants With ≥1 Solicited Injection-site Adverse Event (AE)	An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited AEs are predefined local AEs (at the injection site) for which the participant was specifically questioned, and noted by the participant in their vaccine report card (VRC). Per protocol, the percentage of participants with ≥1 solicited injection site AE has been reported separately based on injection site for participants in the Concomitant Group (Day 1 mRNA-1273 Dose 1 right arm; Day 1 9vHPV Dose 1 left arm; Month 1 mRNA-1273 Dose 2 right arm; Month 6 9vHPV Dose 2 left arm) and Non-Concomitant Group (Day 1 mRNA-1273 Dose 1 right arm; Month 1 mRNA-1273 Dose 2 right arm; Month 2 9vHPV Dose 1 left arm; Month 8 9vHPV Dose 2 left arm). Per protocol, reporting for Concomitant Group Day 1 Dose 1 separated by injection site is specific to this outcome only and does not apply to other safety outcomes.	Up to approximately Day 7 post vaccination with any study vaccine
Percentage of Participants With ≥1 Solicited Systemic AE	An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited AEs are predefined systemic events for which the participant is specifically questioned, and which are noted by the participant in their VRC. Per protocol the percentage of participants who experienced ≥1 solicited systemic (affecting the whole body) AE are reported here for participants in the Concomitant (Day 1 mRNA-1273 Dose 1 right arm + 9vHPV Dose 1 left arm; Month 1 mRNA-1273 Dose 2 right arm; Month 6 9vHPV Dose 2 left arm) and Non-Concomitant Groups (Day 1 mRNA-1273 Dose 1 right arm; Month 1 mRNA-1273 Dose 2 right arm; Month 2 9vHPV Dose 1 left arm; Month 8 9vHPV Dose 2 left arm). Per protocol, reporting is based on time of injection; as 9vHPV Dose 1 AND mRNA-1273 Dose 1 were both given on Day 1 of the Concomitant Group they have been combined below.	Up to approximately Day 7 post vaccination with any study vaccine
Percentage of Participants With ≥1 Serious Adverse Event (SAE)	A serious adverse event (SAE) was defined as one that results in death, is life threatening, or requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical event that may require medical intervention. Per protocol the percentage of participants who experienced ≥1 SAE are reported here for participants in the Concomitant (Day 1 mRNA-1273 Dose 1 right arm + 9vHPV Dose 1 left arm; Month 1 mRNA-1273 Dose 2 right arm; Month 6 9vHPV Dose 2 left arm) and Non-Concomitant Groups (Day 1 mRNA-1273 Dose 1 right arm; Month 1 mRNA-1273 Dose 2 right arm; Month 2 9vHPV Dose 1 left arm; Month 8 9vHPV Dose 2 left arm). Per protocol, reporting is based on time of injection; as 9vHPV Dose 1 AND mRNA-1273 Dose 1 were both given on Day 1 of the Concomitant Group they have been combined below.	Up to approximately Day 28 post vaccination with any study vaccine
Percentage of Participants With ≥1 Vaccine-Related SAE	A SAE was defined as one that results in death, is life threatening, or requires hospitalization/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is a congenital anomaly/birth defect, or other important medical event that may require medical intervention. An SAE judged by the investigator to be related to the study vaccine is a vaccine-related SAE. Per protocol the percentage of participants who experienced ≥1 vaccine-related SAE are reported here for participants in Concomitant (Day 1 mRNA-1273 Dose 1 right arm + 9vHPV Dose 1 left arm; Month 1 mRNA-1273 Dose 2 right arm; Month 6 9vHPV Dose 2 left arm) and Non-Concomitant Groups (Day 1 mRNA-1273 Dose 1 right arm; Month 1 mRNA-1273 Dose 2 right arm; Month 2 9vHPV Dose 1 left arm; Month 8 9vHPV Dose 2 left arm). Per protocol, reporting is based on time of injection; as 9vHPV Dose 1 AND mRNA-1273 Dose 1 were both given on Day 1 of the Concomitant Group they have been combined below.	Up to approximately 9 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Seroconvert to Each of the 9vHPV Vaccine Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 Following Administration of a 2-Dose Regimen of 9vHPV Vaccine	Serum-derived antibodies to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were measured with a competitive luminex immunoassay (cLIA). Seroconversion is defined as changing from cLIA anti-HPV seronegative serum antibodies for 9vHPV types at pre-vaccination to cLIA anti-HPV seropositive at 4 weeks post vaccination with 9vHPV Dose 2. A participant with anti-HPV cLIA titer at or above the serostatus cutoff values of the cLIA for a given HPV type is considered seropositive for that HPV type. The serostatus cutoffs (milli Merck units/milliliter (mMU/mL) for HPV types were as follows: HPV Type 6: ≥34, HPV Type 11: ≥25; HPV Type 16: ≥32, HPV Type 18: ≥26, HPV Type 31: ≥15, HPV Type 33: ≥10, HPV Type 45: ≥10, HPV Type 52: ≥14, and HPV Type 58: ≥10. Percentage of participants who seroconverted are reported for both arms for all randomized participants included in the PPI population. The PPI population is HPV-type specific.	Up to approximately 4 weeks post vaccination with 9vHPV Dose 2
Percentage of Participants Who Experience Seroresponse Following Administration of a 2-Dose Regimen of mRNA-1273 Vaccine	Serum-derived antibodies to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike protein was determined using an electrochemiluminescence (ECL) assay. Seroresponse is defined as a ≥4-fold rise in SARS-CoV-2 spike protein-specific binding antibody concentration from baseline to 4 weeks post vaccination with mRNA-1273 Dose 2. Percentage of participants who experience seroresponse are reported for both arms for all randomized participants included in the mRNA-1273-PP population.	Up to approximately 4 weeks post vaccination with mRNA-1273 Dose 2

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Actual): December 12, 2023
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Tumor Virus Infections; Pathological Conditions, Signs and Symptoms; COVID-19; Papillomavirus Infections; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Biological Products; Complex Mixtures; Vaccines; Viral Vaccines; mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Antigens; 2019-nCoV Vaccine mRNA-1273; COVID-19 Vaccines
• Other Study ID Numbers: V503-076; 2021-003591-13 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No