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)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Papillomavirus Infections, Coronavirus Disease (COVID-19)

Intervention / Treatment
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* Biological: 9vHPV Vaccine
* Biological: mRNA-1273 Vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concomitant Group<br>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<br>* 9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular (IM) injection<br>* Other names: SILGARD®9;Biological: mRNA-1273 Vaccine<br>* mRNA-1273 50 mcg dose administered as a 0.25-mL IM injection<br>* Other names: Moderna COVID-19 Vaccine;|
| Experimental: Non-concomitant Group<br>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<br>* 9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular (IM) injection<br>* Other names: SILGARD®9;Biological: mRNA-1273 Vaccine<br>* mRNA-1273 50 mcg dose administered as a 0.25-mL IM injection<br>* Other names: Moderna COVID-19 Vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titers of Anti-Human Papillomavirus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | 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. | 4 weeks post vaccination 2 | 
| Geometric Mean Concentrations of SARS-CoV-2 Spike Protein-Specific Binding Antibodies | Serum antibodies to SARS-CoV-2 spike protein measured by electrochemiluminescence (ECL) | 4 weeks post vaccination 2 | 
| Percentage of Participants with at Least 1 Solicited Injection-site Adverse Event | 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). | Up to Day 7 post vaccination | 
| Percentage of Participants with at Least 1 Solicited Systemic AE | 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. | Up to Day 7 post vaccination | 
| Percentage of Participants with at Least 1 Serious Adverse Event | 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. | Up to  Month 9 | 
| Percentage of Participants with at Least 1 Vaccine-Related SAE | 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. | Up to  Month 9 | 

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