Clinical trial NCT05119855: 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Papillomavirus Infections
Coronavirus Disease (COVID-19)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2021-11-15
Enrollment: 165
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Geometric Mean Titers of Anti-Human Papillomavirus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
timeFrame: 4 weeks post vaccination 2
measure: Geometric Mean Concentrations of SARS-CoV-2 Spike Protein-Specific Binding Antibodies
timeFrame: 4 weeks post vaccination 2
measure: Percentage of Participants with at Least 1 Solicited Injection-site Adverse Event
timeFrame: Up to Day 7 post vaccination
measure: Percentage of Participants with at Least 1 Solicited Systemic AE
timeFrame: Up to Day 7 post vaccination
measure: Percentage of Participants with at Least 1 Serious Adverse Event
timeFrame: Up to ~Month 9
measure: Percentage of Participants with at Least 1 Vaccine-Related SAE
timeFrame: Up to ~Month 9
Secondary outcomes:
measure: 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
timeFrame: 4 weeks post vaccination 2
measure: Percentage of Participants Who Experience Seroresponse Following Administration of a 2-Dose Regimen of mRNA-1273 Vaccine
timeFrame: 4 weeks post vaccination 2
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Cognitive Clinical Trials, LLC ( Site 0054)
state: Arizona
city: Tucson
country: United States
facility: Eclipse Clinical Research ( Site 0095)
state: Arizona
city: Jonesboro
country: United States
facility: Children's Clinic of Jonesboro, PA ( Site 0044)
state: Arkansas
city: Little Rock
country: United States
facility: Preferred Research Partners Inc. ( Site 0092)
state: Arkansas
city: Bellflower
country: United States
facility: Coast Clinical Research, LLC ( Site 0027)
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research ( Site 0098)
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials Inc. ( Site 0004)
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research ( Site 0051)
state: California
city: Tustin
country: United States
facility: Ark Clinical Research ( Site 0108)
state: California
city: Washington
country: United States
facility: Emerson Clinical Research Institute ( Site 0021)
state: District of Columbia
city: DeLand
country: United States
facility: Accel Research Sites-DeLand Clinical Research Unit ( Site 0066)
state: Florida
city: Immokalee
country: United States
facility: Advanced Research for Health Improvement, LLC ( Site 0012)
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research Associates ( Site 0001)
state: Florida
city: Miami
country: United States
facility: Alpha Science Research ( Site 0067)
state: Florida
city: Naples
country: United States
facility: Advanced Research For Health Improvement LLC ( Site 0075)
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Research ( Site 0038)
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research ( Site 0055)
state: Georgia
city: Sandy Springs
country: United States
facility: Mount Vernon Clinical Research ( Site 0053)
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime ( Site 0088)
state: Idaho
city: Gaithersburg
country: United States
facility: CBH Health ( Site 0019)
state: Maryland
city: Ridgeland
country: United States
facility: SKY Integrative Medical Center/SKYCRNG ( Site 0084)
state: Mississippi
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute ( Site 0003)
state: Nebraska
city: Cortland
country: United States
facility: Certified Research Associates ( Site 0090)
state: New York
city: Horseheads
country: United States
facility: Corning Center for Clinical Research ( Site 0091)
state: New York
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research, LLC ( Site 0042)
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research, Inc. ( Site 0014)
state: North Carolina
city: Dayton
country: United States
facility: Dayton Clinical Research ( Site 0028)
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University - Family and Community Medicine ( Site 0006)
state: Pennsylvania
city: Chattanooga
country: United States
facility: WR-ClinSearch ( Site 0049)
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc. ( Site 0056)
state: Texas
city: Corpus Christi
country: United States
facility: South Texas Clinical Research ( Site 0024)
state: Texas
city: Del Rio
country: United States
facility: South Texas Pediatric Research Group ( Site 0094)
state: Texas
city: Houston
country: United States
facility: West Houston Clinical Research Services ( Site 0078)
state: Texas
city: Houston
country: United States
facility: Next Level Urgent Care, LLC ( Site 0099)
state: Texas
city: Laredo
country: United States
facility: Milton Haber, M.D. ( Site 0069)
state: Texas
city: League City
country: United States
facility: University of Texas Medical Branch ( Site 0026)
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah ( Site 0076)
state: Utah
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City ( Site 0025)
state: Utah
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: