Papillomavirus Infections Clinical Trial
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
| Verified date | December 2023 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 165 |
| Est. completion date | December 12, 2023 |
| Est. primary completion date | December 12, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 9 Years to 11 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Atlanta Center for Medical Research ( Site 0055) | Atlanta | Georgia |
| United States | DermResearch, Inc. ( Site 0056) | Austin | Texas |
| United States | Coast Clinical Research, LLC ( Site 0027) | Bellflower | California |
| United States | WR-ClinSearch ( Site 0049) | Chattanooga | Tennessee |
| United States | South Texas Clinical Research ( Site 0024) | Corpus Christi | Texas |
| United States | Certified Research Associates ( Site 0090) | Cortland | New York |
| United States | Dayton Clinical Research ( Site 0028) | Dayton | Ohio |
| United States | South Texas Pediatric Research Group ( Site 0094) | Del Rio | Texas |
| United States | Accel Research Sites-DeLand Clinical Research Unit ( Site 0066) | DeLand | Florida |
| United States | Carolina Institute for Clinical Research, LLC ( Site 0042) | Fayetteville | North Carolina |
| United States | CBH Health ( Site 0019) | Gaithersburg | Maryland |
| United States | Corning Center for Clinical Research ( Site 0091) | Horseheads | New York |
| United States | Next Level Urgent Care, LLC ( Site 0099) | Houston | Texas |
| United States | West Houston Clinical Research Services ( Site 0078) | Houston | Texas |
| United States | Clinical Research Prime ( Site 0088) | Idaho Falls | Idaho |
| United States | Advanced Research for Health Improvement, LLC ( Site 0012) | Immokalee | Florida |
| United States | Children's Clinic of Jonesboro, PA ( Site 0044) | Jonesboro | Arkansas |
| United States | Milton Haber, M.D. ( Site 0069) | Laredo | Texas |
| United States | University of Texas Medical Branch ( Site 0026) | League City | Texas |
| United States | Midwest Children's Health Research Institute ( Site 0003) | Lincoln | Nebraska |
| United States | Preferred Research Partners Inc. ( Site 0092) | Little Rock | Arkansas |
| United States | Ark Clinical Research ( Site 0098) | Long Beach | California |
| United States | Acevedo Clinical Research Associates ( Site 0001) | Miami | Florida |
| United States | Alpha Science Research ( Site 0067) | Miami | Florida |
| United States | Advanced Research For Health Improvement LLC ( Site 0075) | Naples | Florida |
| United States | Valley Clinical Trials Inc. ( Site 0004) | Northridge | California |
| United States | Thomas Jefferson University - Family and Community Medicine ( Site 0006) | Philadelphia | Pennsylvania |
| United States | Cognitive Clinical Trials, LLC ( Site 0054) | Phoenix | Arizona |
| United States | M3 Wake Research, Inc. ( Site 0014) | Raleigh | North Carolina |
| United States | SKY Integrative Medical Center/SKYCRNG ( Site 0084) | Ridgeland | Mississippi |
| United States | University of Utah ( Site 0076) | Salt Lake City | Utah |
| United States | Medical Center for Clinical Research ( Site 0051) | San Diego | California |
| United States | Mount Vernon Clinical Research ( Site 0053) | Sandy Springs | Georgia |
| United States | Eclipse Clinical Research ( Site 0095) | Tucson | Arizona |
| United States | Ark Clinical Research ( Site 0108) | Tustin | California |
| United States | Emerson Clinical Research Institute ( Site 0021) | Washington | District of Columbia |
| United States | Velocity Clinical Research, Salt Lake City ( Site 0025) | West Jordan | Utah |
| United States | Comprehensive Clinical Research ( Site 0038) | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | 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 | |
| Secondary | 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 |
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