Back to resultsSafety 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)
Primary Purpose
Papillomavirus Infections, Coronavirus Disease (COVID-19)
Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
9vHPV Vaccine
mRNA-1273 Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Papillomavirus Infections
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
Sites / Locations
- Cognitive Clinical Trials, LLC ( Site 0054)
- Eclipse Clinical Research ( Site 0095)
- Children's Clinic of Jonesboro, PA ( Site 0044)
- Preferred Research Partners Inc. ( Site 0092)
- Coast Clinical Research, LLC ( Site 0027)
- Ark Clinical Research ( Site 0098)
- Valley Clinical Trials Inc. ( Site 0004)
- Medical Center for Clinical Research ( Site 0051)
- Ark Clinical Research ( Site 0108)
- Emerson Clinical Research Institute ( Site 0021)
- Accel Research Sites-DeLand Clinical Research Unit ( Site 0066)
- Advanced Research for Health Improvement, LLC ( Site 0012)
- Acevedo Clinical Research Associates ( Site 0001)
- Alpha Science Research ( Site 0067)
- Advanced Research For Health Improvement LLC ( Site 0075)
- Comprehensive Clinical Research ( Site 0038)
- Atlanta Center for Medical Research ( Site 0055)
- Mount Vernon Clinical Research ( Site 0053)
- Clinical Research Prime ( Site 0088)
- CBH Health ( Site 0019)
- SKY Integrative Medical Center/SKYCRNG ( Site 0084)
- Midwest Children's Health Research Institute ( Site 0003)
- Certified Research Associates ( Site 0090)
- Corning Center for Clinical Research ( Site 0091)
- Carolina Institute for Clinical Research, LLC ( Site 0042)
- M3 Wake Research, Inc. ( Site 0014)
- Dayton Clinical Research ( Site 0028)
- Thomas Jefferson University - Family and Community Medicine ( Site 0006)
- WR-ClinSearch ( Site 0049)
- DermResearch, Inc. ( Site 0056)
- South Texas Clinical Research ( Site 0024)
- South Texas Pediatric Research Group ( Site 0094)
- West Houston Clinical Research Services ( Site 0078)
- Next Level Urgent Care, LLC ( Site 0099)
- Milton Haber, M.D. ( Site 0069)
- University of Texas Medical Branch ( Site 0026)
- University of Utah ( Site 0076)
- Velocity Clinical Research, Salt Lake City ( Site 0025)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Concomitant Group
Non-concomitant Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Geometric Mean Concentrations of SARS-CoV-2 Spike Protein-Specific Binding Antibodies
Serum antibodies to SARS-CoV-2 spike protein measured by electrochemiluminescence (ECL)
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).
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05119855
First Posted
November 10, 2021
Last Updated
March 23, 2023
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT05119855
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
January 12, 2024 (Anticipated)
Study Completion Date
January 12, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillomavirus Infections, Coronavirus Disease (COVID-19)
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Concomitant Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-concomitant Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
9vHPV Vaccine
Other Intervention Name(s)
V503, GARDASIL®9, SILGARD®9
Intervention Description
9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular (IM) injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1273 Vaccine
Other Intervention Name(s)
SARS-CoV-2 Vaccine, Moderna COVID-19 Vaccine
Intervention Description
mRNA-1273 50 mcg dose administered as a 0.25-mL IM injection
Primary Outcome Measure Information:
Title
Geometric Mean Titers of Anti-Human Papillomavirus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Description
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.
Time Frame
4 weeks post vaccination 2
Title
Geometric Mean Concentrations of SARS-CoV-2 Spike Protein-Specific Binding Antibodies
Description
Serum antibodies to SARS-CoV-2 spike protein measured by electrochemiluminescence (ECL)
Time Frame
4 weeks post vaccination 2
Title
Percentage of Participants with at Least 1 Solicited Injection-site Adverse Event
Description
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).
Time Frame
Up to Day 7 post vaccination
Title
Percentage of Participants with at Least 1 Solicited Systemic AE
Description
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.
Time Frame
Up to Day 7 post vaccination
Title
Percentage of Participants with at Least 1 Serious Adverse Event
Description
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.
Time Frame
Up to ~Month 9
Title
Percentage of Participants with at Least 1 Vaccine-Related SAE
Description
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.
Time Frame
Up to ~Month 9
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
4 weeks post vaccination 2
Title
Percentage of Participants Who Experience Seroresponse Following Administration of a 2-Dose Regimen of mRNA-1273 Vaccine
Description
Serum antibodies to SARS-CoV-2 spike protein measured by ECL assay. Percentage of participants who experience seroresponse will be assessed.
Time Frame
4 weeks post vaccination 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Cognitive Clinical Trials, LLC ( Site 0054)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85044
Country
United States
Facility Name
Eclipse Clinical Research ( Site 0095)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Children's Clinic of Jonesboro, PA ( Site 0044)
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Preferred Research Partners Inc. ( Site 0092)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Coast Clinical Research, LLC ( Site 0027)
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Ark Clinical Research ( Site 0098)
City
Long Beach
State/Province
California
ZIP/Postal Code
90815
Country
United States
Facility Name
Valley Clinical Trials Inc. ( Site 0004)
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Medical Center for Clinical Research ( Site 0051)
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Ark Clinical Research ( Site 0108)
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Emerson Clinical Research Institute ( Site 0021)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20011
Country
United States
Facility Name
Accel Research Sites-DeLand Clinical Research Unit ( Site 0066)
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Advanced Research for Health Improvement, LLC ( Site 0012)
City
Immokalee
State/Province
Florida
ZIP/Postal Code
34142
Country
United States
Facility Name
Acevedo Clinical Research Associates ( Site 0001)
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Alpha Science Research ( Site 0067)
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Advanced Research For Health Improvement LLC ( Site 0075)
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Comprehensive Clinical Research ( Site 0038)
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Atlanta Center for Medical Research ( Site 0055)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Mount Vernon Clinical Research ( Site 0053)
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Clinical Research Prime ( Site 0088)
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
CBH Health ( Site 0019)
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Facility Name
SKY Integrative Medical Center/SKYCRNG ( Site 0084)
City
Ridgeland
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Facility Name
Midwest Children's Health Research Institute ( Site 0003)
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68505
Country
United States
Facility Name
Certified Research Associates ( Site 0090)
City
Cortland
State/Province
New York
ZIP/Postal Code
13045
Country
United States
Facility Name
Corning Center for Clinical Research ( Site 0091)
City
Horseheads
State/Province
New York
ZIP/Postal Code
14845
Country
United States
Facility Name
Carolina Institute for Clinical Research, LLC ( Site 0042)
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28303
Country
United States
Facility Name
M3 Wake Research, Inc. ( Site 0014)
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Dayton Clinical Research ( Site 0028)
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Thomas Jefferson University - Family and Community Medicine ( Site 0006)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
WR-ClinSearch ( Site 0049)
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
DermResearch, Inc. ( Site 0056)
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
South Texas Clinical Research ( Site 0024)
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
South Texas Pediatric Research Group ( Site 0094)
City
Del Rio
State/Province
Texas
ZIP/Postal Code
78840
Country
United States
Facility Name
West Houston Clinical Research Services ( Site 0078)
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Next Level Urgent Care, LLC ( Site 0099)
City
Houston
State/Province
Texas
ZIP/Postal Code
77057
Country
United States
Facility Name
Milton Haber, M.D. ( Site 0069)
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Facility Name
University of Texas Medical Branch ( Site 0026)
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
University of Utah ( Site 0076)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Velocity Clinical Research, Salt Lake City ( Site 0025)
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Learn more about this trial
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)
We'll reach out to this number within 24 hrs