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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)

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ClinicalTrials.gov Identifier: NCT05119855
Recruitment Status : Recruiting
First Posted : November 15, 2021
Last Update Posted : November 10, 2022
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Brief Summary:
The primary hypothesis is that concomitant administration of the first doses of a 2-dose regimen of 9vHPV vaccine and 2-dose regimen of mRNA-1273 vaccine induces noninferior geometric mean titers (GMTs) of antibodies to each of the 9vHPV vaccine types at 4 weeks postdose 2 of 9vHPV vaccine AND noninferior geometric mean concentrations (GMCs) of SARS-CoV-2 spike protein-specific binding antibody at 4 weeks Postdose 2 of mRNA-1273 vaccine, compared with the corresponding postdose 2 GMTs/GMCs induced by a 2-dose regimen of 9vHPV vaccine and mRNA-1273 vaccine, where the first doses of each are administered nonconcomitantly.

Condition or disease Intervention/treatment Phase
Papillomavirus Infections Coronavirus Disease (COVID-19) Biological: 9vHPV Vaccine Biological: mRNA-1273 Vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : March 28, 2022
Estimated Primary Completion Date : November 9, 2023
Estimated Study Completion Date : November 9, 2023


Arm Intervention/treatment
Experimental: Concomitant Group
Participants will receive the first dose of 9vHPV vaccine and first dose of mRNA-1273 vaccine on Day 1; participants will then receive the second dose of mRNA-1273 vaccine at Month 1 and the second dose of 9vHPV vaccine 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:
  • V503
  • GARDASIL®9
  • SILGARD®9

Biological: mRNA-1273 Vaccine
mRNA-1273 50 mcg dose administered as a 0.25-mL IM injection
Other Names:
  • SARS-CoV-2 Vaccine
  • Moderna COVID-19 Vaccine

Experimental: Non-concomitant Group
Participants will receive the first and second doses of mRNA-1273 vaccine on Day 1 and at Month 1, respectively; participants will then receive the first and second doses of 9vHPV vaccine at Months 2 and 8, respectively.
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:
  • V503
  • GARDASIL®9
  • SILGARD®9

Biological: mRNA-1273 Vaccine
mRNA-1273 50 mcg dose administered as a 0.25-mL IM injection
Other Names:
  • SARS-CoV-2 Vaccine
  • Moderna COVID-19 Vaccine




Primary Outcome Measures :
  1. Geometric Mean Titers of Anti-Human Papillomavirus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 [ Time Frame: 4 weeks post vaccination 2 ]
    Serum antibodies to human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58 will be measured with a competitive luminex immunoassay (cLIA). Titers are reported in milli Merck Units/mL.

  2. Geometric Mean Concentrations of SARS-CoV-2 Spike Protein-Specific Binding Antibodies [ Time Frame: 4 weeks post vaccination 2 ]
    Serum antibodies to SARS-CoV-2 spike protein measured by electrochemiluminescence (ECL)

  3. Percentage of Participants with at Least 1 Solicited Injection-site Adverse Event [ Time Frame: Up to Day 7 post vaccination ]
    An adverse event (AE) is 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 (at the injection site) for which the participant is specifically questioned, and which are noted by the participant in their vaccine report card (VRC).

  4. Percentage of Participants with at Least 1 Solicited Systemic AE [ Time Frame: Up to Day 7 post vaccination ]
    An AE is 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.

  5. Percentage of Participants with at Least 1 Serious Adverse Event [ Time Frame: Up to ~Month 9 ]
    A serious adverse event (SAE) is 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.

  6. Percentage of Participants with at Least 1 Vaccine-Related SAE [ Time Frame: Up to ~Month 9 ]
    An SAE is 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. An SAE that is judged by the investigator to be related to the study vaccine is a vaccine-related SAE.


Secondary Outcome Measures :
  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 [ Time Frame: 4 weeks post vaccination 2 ]
    Serum antibodies to human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58 will be measured with a competitive luminex immunoassay (cLIA). Percentage of participants who seroconverted will be assessed.

  2. Percentage of Participants Who Experience Seroresponse Following Administration of a 2-Dose Regimen of mRNA-1273 Vaccine [ Time Frame: 4 weeks post vaccination 2 ]
    Serum antibodies to SARS-CoV-2 spike protein measured by ECL assay. Percentage of participants who experience seroresponse will be assessed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   9 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05119855


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
Show Show 38 study locations
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT05119855    
Other Study ID Numbers: V503-076
2021-003591-13 ( EudraCT Number )
First Posted: November 15, 2021    Key Record Dates
Last Update Posted: November 10, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Papillomavirus Infections
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
DNA Virus Infections
Tumor Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs