A Study to Evaluate the Immunogenicity, Safety and Tolerability of Quadrivalent Human Papillomavirus Vaccine (V501) in Chinese Girls Aged 9-19 Years and Young Women Aged 20-26 Years (V501-213)
NCT ID: NCT03493542
Last Updated: 2024-12-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
766 participants
INTERVENTIONAL
2018-08-31
2023-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Chinese Girls Aged 9 to 19 Years
Participants will receive V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
V501
0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6
Chinese Young Women Aged 20 to 26 Years
Participants will receive V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
V501
0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6
Interventions
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V501
0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant and participant's parent or guardian (participants aged 9-17 years only) provided written informed consent/assent.
* Provided a primary and alternative telephone for follow-up purposes.
* Extension Stage: participant was enrolled in the 9-19 years old group, received 3 doses of V501 in the Base Stage, and participant and participant's legally acceptable representative (if applicable) provided written informed consent/assent for the study extension.
Exclusion Criteria
* Allergic to any vaccine component, including aluminum, yeast, or Benzonase® (nuclease).
* Known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
* Currently immunocompromised or was diagnosed as having congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition.
* History of splenectomy.
* Any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives.
* History of recent or ongoing alcohol or other drug abuse.
* History of a positive test for HPV.
* Any history of abnormal Pap test.
* History of external genital wart, vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), vulvar cancer or vaginal cancer.
* Undergone hysterectomy (either vaginal or total abdominal hysterectomy).
* Receiving or has received in the year prior to Day 1 vaccination an excluded immunosuppressive therapy. A participant will be excluded if she is currently receiving steroid therapy, has recently received such therapy, or has received 2 or more courses of corticosteroids (orally or parenterally) lasting at least 1 week in duration in the year prior to Day 1 vaccination. Participants using inhaled, nasal or topical steroids are considered eligible for the study.
* Received immune globulin product or blood-derived product within 6 months prior to Day 1 vaccination, or plans to receive any such product during the study.
* Received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
* Received inactivated or recombinant vaccines within 14 days prior to Day 1 vaccination or receipt of live vaccines within 21 days prior to Day 1 vaccination.
* Concurrently enrolled in a clinical study of investigational agents.
* Had \>4 lifetime sexual partners.
* Unlikely to adhere to the study procedures, keep appointments, or is planning to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled.
* An immediate family member who is investigational site or sponsor staff directly involved with this study.
* Extension Stage: reported overdose or received non-study HPV vaccine during the Base Stage.
9 Years
26 Years
FEMALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Yangchun Center For Disease Prevention And Control ( Site 0003)
Yangchun, Guangdong, China
Countries
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References
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Huang Z, He J, Su J, Ou Z, Liu G, Fu R, Shou Q, Zheng M, Group T, Luxembourg A, Liao X, Zhang J. Immunogenicity and safety of the quadrivalent human papillomavirus vaccine in Chinese females aged 9 to 26 years: A phase 3, open-label, immunobridging study. Vaccine. 2021 Jan 22;39(4):760-766. doi: 10.1016/j.vaccine.2020.11.008. Epub 2020 Nov 22.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Other Identifiers
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V501-213
Identifier Type: OTHER
Identifier Source: secondary_id
2023-001144-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V501-213
Identifier Type: -
Identifier Source: org_study_id