A Study of the Safety, Tolerability, and Immunogenicity of a 9-valent Human Papillomavirus Vaccine ([9vHPV]; V503) Administered to 9- to 15-Year-Old Japanese Girls (V503-008).
Primary Purpose
Papillomavirus Infections
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
V503
Sponsored by
About this trial
This is an interventional prevention trial for Papillomavirus Infections focused on measuring Papillomavirus vaccines, Uterine cervical cancer, Human Papilloma Virus infections
Eligibility Criteria
Inclusion Criteria:
- Participant is in good physical health-
- Participant's parent/legal guardian is able to read, understand, and complete the vaccine report card
- Participant's parent/legal guardian agrees to provide a phone number for follow-up purposes
- Participant is not sexually active and does not plan to become sexually active during the time from Day 1 to Month 7 of the study
Exclusion Criteria:
- Participant has a history of severe allergic reaction that required medical intervention
- Participant has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
- Participant is pregnant
- Participant intends to donate blood during the time from Day 1 to Month 7 of the study
- Participant is immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
- Participant has had a splenectomy
- Participant has received any of the following immunosuppressive therapies in the year prior to enrollment: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava), tumor necrosis factor alpha (TNF-α) antagonists, monoclonal antibody therapies, antilymphocyte sera, or other therapy known to interfere with the immune response.
- Participant has received any immune globulin product or blood-derived product in the three months prior to the Day 1 vaccination, or plans to receive any such product through Month 7 of the study
- Participant has received any inactivated vaccines within 14 days of the Day 1 vaccination or any live vaccines within 28 days of the Day 1 vaccination
- Participant has received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
- Participant has had a fever (oral temperature ≥37.8°C) within 24 hours of the Day 1 vaccination
- Participant has a history of a positive test for HPV or history of genital warts
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All Enrolled
Arm Description
9-valent human papillomavirus (9vHPV) L1 VLP vaccine (V503), 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
Outcomes
Primary Outcome Measures
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine
Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.
Percentage of Participants With an Injection-site Adverse Event (AE)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.
Percentage of Participants With a Non-Injection Site (Systemic) AE
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.
Percentage of Participants With a Vaccine-related AE
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Adverse experience that is judged by the Investigator to be "definitely related," "probably related," or "possibly related" to the study drug is defined as a vaccine-related AE.
Secondary Outcome Measures
Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine
Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers are reported in milli Merck Units/mL.
Full Information
NCT ID
NCT01254643
First Posted
December 3, 2010
Last Updated
October 30, 2018
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01254643
Brief Title
A Study of the Safety, Tolerability, and Immunogenicity of a 9-valent Human Papillomavirus Vaccine ([9vHPV]; V503) Administered to 9- to 15-Year-Old Japanese Girls (V503-008).
Official Title
A Phase III Open-label, Safety, Tolerability and Immunogenicity Study of a 9-Valent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 9- to 15-Year-Old Japanese Preadolescent and Adolescent Girls
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 12, 2011 (Actual)
Primary Completion Date
August 10, 2013 (Actual)
Study Completion Date
August 10, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the safety, tolerability, and immunogenicity of V503 in Japanese girls between the ages of 9 and 15 and will determine whether V503 induces an acceptable immune response to all human papillomavirus (HPV) strains contained in the vaccine. The success criterion for the primary analysis requires that point estimates for seroconversion rate be greater than 90% for all 9 HPV types.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillomavirus Infections
Keywords
Papillomavirus vaccines, Uterine cervical cancer, Human Papilloma Virus infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All Enrolled
Arm Type
Experimental
Arm Description
9-valent human papillomavirus (9vHPV) L1 VLP vaccine (V503), 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
Intervention Type
Biological
Intervention Name(s)
V503
Intervention Description
V503 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
Primary Outcome Measure Information:
Title
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine
Description
Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using competitive luminex immunoassay (cLIA). The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.
Time Frame
4 weeks post-vaccination 3 (Month 7)
Title
Percentage of Participants With an Injection-site Adverse Event (AE)
Description
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. AEs such as redness, swelling, and pain/tenderness/soreness at the injection site were recorded.
Time Frame
up to 5 days after any vaccination
Title
Percentage of Participants With a Non-Injection Site (Systemic) AE
Description
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Systemic AEs were those not categorized as injection-site AEs.
Time Frame
up to 15 days after any vaccination
Title
Percentage of Participants With a Vaccine-related AE
Description
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Adverse experience that is judged by the Investigator to be "definitely related," "probably related," or "possibly related" to the study drug is defined as a vaccine-related AE.
Time Frame
up to 15 days after any vaccination
Secondary Outcome Measure Information:
Title
Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine
Description
Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers are reported in milli Merck Units/mL.
Time Frame
4 weeks post-vaccination 3 (Month 7)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participant is in good physical health-
Participant's parent/legal guardian is able to read, understand, and complete the vaccine report card
Participant's parent/legal guardian agrees to provide a phone number for follow-up purposes
Participant is not sexually active and does not plan to become sexually active during the time from Day 1 to Month 7 of the study
Exclusion Criteria:
Participant has a history of severe allergic reaction that required medical intervention
Participant has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
Participant is pregnant
Participant intends to donate blood during the time from Day 1 to Month 7 of the study
Participant is immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.
Participant has had a splenectomy
Participant has received any of the following immunosuppressive therapies in the year prior to enrollment: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava), tumor necrosis factor alpha (TNF-α) antagonists, monoclonal antibody therapies, antilymphocyte sera, or other therapy known to interfere with the immune response.
Participant has received any immune globulin product or blood-derived product in the three months prior to the Day 1 vaccination, or plans to receive any such product through Month 7 of the study
Participant has received any inactivated vaccines within 14 days of the Day 1 vaccination or any live vaccines within 28 days of the Day 1 vaccination
Participant has received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
Participant has had a fever (oral temperature ≥37.8°C) within 24 hours of the Day 1 vaccination
Participant has a history of a positive test for HPV or history of genital warts
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
28003597
Citation
Iwata S, Murata S, Rong Han S, Wakana A, Sawata M, Tanaka Y. Safety and Immunogenicity of a 9-Valent Human Papillomavirus Vaccine Administered to 9- to 15-Year-Old Japanese Girls. Jpn J Infect Dis. 2017 Jul 24;70(4):368-373. doi: 10.7883/yoken.JJID.2016.299. Epub 2016 Dec 22.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/study.html?id=V503-008&kw=V503-008&tab=access
Learn more about this trial
A Study of the Safety, Tolerability, and Immunogenicity of a 9-valent Human Papillomavirus Vaccine ([9vHPV]; V503) Administered to 9- to 15-Year-Old Japanese Girls (V503-008).
We'll reach out to this number within 24 hrs