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)

NCT05119855 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: V503-0762021-003591-13
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 38

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.

Conditions

Papillomavirus Infections; Coronavirus Disease (COVID-19)

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

Concomitant Group

EXPERIMENTAL

Participants will receive Dose 1 of 9-valent human papillomavirus \[Types 6, 11, 16, 18, 31, 33, 45, 52, 58\] (9vHPV) vaccine administered into the left arm as an intramuscular (IM) injection, AND Dose 1 of the messenger ribonucleic acid (mRNA)-1273 vaccine administered into the right arm as an IM injection on Day 1; participants will then receive Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 6.

Biological: 9vHPV Vaccine; Biological: mRNA-1273 Vaccine

Non-concomitant Group

EXPERIMENTAL

Participants will receive Dose 1 of the mRNA-1273 vaccine administered into the right arm as an IM injection on Day 1 and Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1. Participants will then receive Dose 1 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 2 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 8.

Biological: 9vHPV Vaccine; Biological: mRNA-1273 Vaccine

Interventions

9vHPV Vaccine BIOLOGICAL

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

Also known as: V503, GARDASIL®9, SILGARD®9

Concomitant Group; Non-concomitant Group

mRNA-1273 Vaccine BIOLOGICAL

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

Also known as: SARS-CoV-2 Vaccine, Moderna COVID-19 Vaccine

Concomitant Group; Non-concomitant Group

Eligibility Criteria

• Age: 9 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (38)

Cognitive Clinical Trials, LLC ( Site 0054)

Phoenix, Arizona, 85044, United States

Location

Eclipse Clinical Research ( Site 0095)

Tucson, Arizona, 85745, United States

Location

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

Jonesboro, Arkansas, 72401, United States

Location

Preferred Research Partners Inc. ( Site 0092)

Little Rock, Arkansas, 72211, United States

Location

Coast Clinical Research, LLC ( Site 0027)

Bellflower, California, 90706, United States

Location

Ark Clinical Research ( Site 0098)

Long Beach, California, 90815, United States

Location

Valley Clinical Trials Inc. ( Site 0004)

Northridge, California, 91325, United States

Location

Medical Center for Clinical Research ( Site 0051)

San Diego, California, 92120, United States

Location

Ark Clinical Research ( Site 0108)

Tustin, California, 92780, United States

Location

Emerson Clinical Research Institute ( Site 0021)

Washington D.C., District of Columbia, 20011, United States

Location

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

DeLand, Florida, 32720, United States

Location

Advanced Research for Health Improvement, LLC ( Site 0012)

Immokalee, Florida, 34142, United States

Location

Acevedo Clinical Research Associates ( Site 0001)

Miami, Florida, 33142, United States

Location

Alpha Science Research ( Site 0067)

Miami, Florida, 33186, United States

Location

Advanced Research For Health Improvement LLC ( Site 0075)

Naples, Florida, 34102, United States

Location

Comprehensive Clinical Research ( Site 0038)

West Palm Beach, Florida, 33409, United States

Location

Atlanta Center for Medical Research ( Site 0055)

Atlanta, Georgia, 30331, United States

Location

Mount Vernon Clinical Research ( Site 0053)

Sandy Springs, Georgia, 30328, United States

Location

Clinical Research Prime ( Site 0088)

Idaho Falls, Idaho, 83404, United States

Location

CBH Health ( Site 0019)

Gaithersburg, Maryland, 20877, United States

Location

SKY Integrative Medical Center/SKYCRNG ( Site 0084)

Ridgeland, Mississippi, 39157, United States

Location

Midwest Children's Health Research Institute ( Site 0003)

Lincoln, Nebraska, 68505, United States

Location

Certified Research Associates ( Site 0090)

Cortland, New York, 13045, United States

Location

Corning Center for Clinical Research ( Site 0091)

Horseheads, New York, 14845, United States

Location

Carolina Institute for Clinical Research, LLC ( Site 0042)

Fayetteville, North Carolina, 28303, United States

Location

M3 Wake Research, Inc. ( Site 0014)

Raleigh, North Carolina, 27612, United States

Location

Dayton Clinical Research ( Site 0028)

Dayton, Ohio, 45409, United States

Location

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

Philadelphia, Pennsylvania, 19107, United States

Location

WR-ClinSearch ( Site 0049)

Chattanooga, Tennessee, 37421, United States

Location

DermResearch, Inc. ( Site 0056)

Austin, Texas, 78759, United States

Location

South Texas Clinical Research ( Site 0024)

Corpus Christi, Texas, 78404, United States

Location

South Texas Pediatric Research Group ( Site 0094)

Del Rio, Texas, 78840, United States

Location

West Houston Clinical Research Services ( Site 0078)

Houston, Texas, 77055, United States

Location

Next Level Urgent Care, LLC ( Site 0099)

Houston, Texas, 77057, United States

Location

Milton Haber, M.D. ( Site 0069)

Laredo, Texas, 78041, United States

Location

University of Texas Medical Branch ( Site 0026)

League City, Texas, 77573, United States

Location

University of Utah ( Site 0076)

Salt Lake City, Utah, 84132, United States

Location

Velocity Clinical Research, Salt Lake City ( Site 0025)

West Jordan, Utah, 84088, United States

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Papillomavirus Infections; COVID-19

Interventions

2019-nCoV Vaccine mRNA-1273; COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; Viral Vaccines; Antigens; Biological Factors

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 15, 2021
• Study Start: March 28, 2022
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: February 5, 2026
• Results First Posted: July 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (38)