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)
- Conditions
- Coronavirus Disease (COVID-19)Papillomavirus Infections
- Interventions
- Biological: 9vHPV VaccineBiological: mRNA-1273 Vaccine
- Registration Number
- NCT05119855
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 165
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-concomitant Group mRNA-1273 Vaccine 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. Concomitant Group 9vHPV Vaccine 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. Concomitant Group mRNA-1273 Vaccine 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. Non-concomitant Group 9vHPV Vaccine 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.
- Primary Outcome Measures
Name Time Method Geometric Mean Titers of Anti-Human Papillomavirus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 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.
Geometric Mean Concentrations of SARS-CoV-2 Spike Protein-Specific Binding Antibodies 4 weeks post vaccination 2 Serum antibodies to SARS-CoV-2 spike protein measured by electrochemiluminescence (ECL)
Percentage of Participants with at Least 1 Solicited Injection-site Adverse Event 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).
Percentage of Participants with at Least 1 Solicited Systemic AE 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.
Percentage of Participants with at Least 1 Serious Adverse Event 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.
Percentage of Participants with at Least 1 Vaccine-Related SAE 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
Name Time Method 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 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.
Percentage of Participants Who Experience Seroresponse Following Administration of a 2-Dose Regimen of mRNA-1273 Vaccine 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.
Trial Locations
- Locations (38)
West Houston Clinical Research Services ( Site 0078)
🇺🇸Houston, Texas, United States
Next Level Urgent Care, LLC ( Site 0099)
🇺🇸Houston, Texas, United States
Ark Clinical Research ( Site 0108)
🇺🇸Tustin, California, United States
Atlanta Center for Medical Research ( Site 0055)
🇺🇸Atlanta, Georgia, United States
Dayton Clinical Research ( Site 0028)
🇺🇸Dayton, Ohio, United States
Medical Center for Clinical Research ( Site 0051)
🇺🇸San Diego, California, United States
Alpha Science Research ( Site 0067)
🇺🇸Miami, Florida, United States
Acevedo Clinical Research Associates ( Site 0001)
🇺🇸Miami, Florida, United States
Accel Research Sites-DeLand Clinical Research Unit ( Site 0066)
🇺🇸DeLand, Florida, United States
Cognitive Clinical Trials, LLC ( Site 0054)
🇺🇸Phoenix, Arizona, United States
Children's Clinic of Jonesboro, PA ( Site 0044)
🇺🇸Jonesboro, Arkansas, United States
CBH Health ( Site 0019)
🇺🇸Gaithersburg, Maryland, United States
Comprehensive Clinical Research ( Site 0038)
🇺🇸West Palm Beach, Florida, United States
Midwest Children's Health Research Institute ( Site 0003)
🇺🇸Lincoln, Nebraska, United States
WR-ClinSearch ( Site 0049)
🇺🇸Chattanooga, Tennessee, United States
Eclipse Clinical Research ( Site 0095)
🇺🇸Tucson, Arizona, United States
SKY Integrative Medical Center/SKYCRNG ( Site 0084)
🇺🇸Ridgeland, Mississippi, United States
Preferred Research Partners Inc. ( Site 0092)
🇺🇸Little Rock, Arkansas, United States
Advanced Research For Health Improvement LLC ( Site 0075)
🇺🇸Naples, Florida, United States
University of Utah ( Site 0076)
🇺🇸Salt Lake City, Utah, United States
Coast Clinical Research, LLC ( Site 0027)
🇺🇸Bellflower, California, United States
Ark Clinical Research ( Site 0098)
🇺🇸Long Beach, California, United States
Valley Clinical Trials Inc. ( Site 0004)
🇺🇸Northridge, California, United States
Emerson Clinical Research Institute ( Site 0021)
🇺🇸Washington, District of Columbia, United States
Advanced Research for Health Improvement, LLC ( Site 0012)
🇺🇸Immokalee, Florida, United States
Mount Vernon Clinical Research ( Site 0053)
🇺🇸Sandy Springs, Georgia, United States
Clinical Research Prime ( Site 0088)
🇺🇸Idaho Falls, Idaho, United States
Certified Research Associates ( Site 0090)
🇺🇸Cortland, New York, United States
Corning Center for Clinical Research ( Site 0091)
🇺🇸Horseheads, New York, United States
Carolina Institute for Clinical Research, LLC ( Site 0042)
🇺🇸Fayetteville, North Carolina, United States
M3 Wake Research, Inc. ( Site 0014)
🇺🇸Raleigh, North Carolina, United States
Thomas Jefferson University - Family and Community Medicine ( Site 0006)
🇺🇸Philadelphia, Pennsylvania, United States
South Texas Clinical Research ( Site 0024)
🇺🇸Corpus Christi, Texas, United States
South Texas Pediatric Research Group ( Site 0094)
🇺🇸Del Rio, Texas, United States
DermResearch, Inc. ( Site 0056)
🇺🇸Austin, Texas, United States
Velocity Clinical Research, Salt Lake City ( Site 0025)
🇺🇸West Jordan, Utah, United States
University of Texas Medical Branch ( Site 0026)
🇺🇸League City, Texas, United States
Milton Haber, M.D. ( Site 0069)
🇺🇸Laredo, Texas, United States