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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03493542
Recruitment Status : Active, not recruiting
First Posted : April 10, 2018
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study is designed to evaluate the immunogenicity, safety, and tolerability of Gardasil™ (quadrivalent human papillomavirus [qHPV] vaccine, V501) in Chinese girls aged 9-19 years and young women aged 20-26 years. The primary hypothesis of the study states that at 1 month postdose 3, a 3-dose regimen of V501 induces non-inferior geometric mean titers (GMTs) for serum anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18 in girls aged 9-19 years compared to young women aged 20-26 years.

Condition or disease Intervention/treatment Phase
Prevention of HPV Types 16- and 18-related Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN) 1/2/3, and Cervical Adenocarcinoma in Situ Biological: V501 Phase 3

Detailed Description:
The study consists of a Base Stage wherein Chinese girls aged 9-19 years and young women aged 20-26 years receive a 3-dose regimen of V501 and are followed up to 1 month postdose 3 (Month 7). Participants aged 9-19 years who received 3 doses of V501 in the Base Stage will be eligible to participate in the Extension Stage and will be followed up to Month 60. No study vaccine will be administered during the Extension Stage.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 766 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 3 Open-Label Clinical Trial to Study the Immunogenicity, Safety and Tolerability of Recombinant Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine (V501) in Chinese Girls Aged 9-19 Years and Young Women Aged 20-26 Years
Actual Study Start Date : August 31, 2018
Actual Primary Completion Date : May 1, 2019
Estimated Study Completion Date : October 19, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chinese Girls Aged 9 to 19 Years
Participants will receive V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
Biological: V501
0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6
Other Names:
  • (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
  • qHPV

Active Comparator: 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
Biological: V501
0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6
Other Names:
  • (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
  • qHPV




Primary Outcome Measures :
  1. Base Stage: Antibody Titers as Measured by Competitive Luminex Immunoassay [ Time Frame: Month 7 (1 month postdose 3) ]
    Geometric mean titers to HPV Types 6, 11, 16, and 18 will be assessed. Antibodies will be measured using a Competitive Luminex Immunoassay (cLIA).

  2. Extension Stage: Antibody Titers as Measured by cLIA [ Time Frame: Month 12, 24, 36, 48, and 60 ]
    Geometric mean titers to HPV Types 6, 11, 16, and 18 will be assessed. Antibodies will be measured using a Competitive Luminex Immunoassay (cLIA). This Outcome Measure applies only to participants aged 9 to 19 years.

  3. Extension Stage: Seropositivity Rates as Measured by cLIA [ Time Frame: Month 12, 24, 36, 48, and 60 ]
    The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 will be assessed. Antibodies will be measured using cLIA. This Outcome Measure applies only to participants aged 9 to 19 years.

  4. Extension Stage: Antibody Titers as Measured by Immunoglobulin G Luminex Immunoassay [ Time Frame: Month 12, 24, 36, 48, and 60 ]
    Geometric mean titers to HPV Types 6, 11, 16, and 18 will be assessed. Antibodies will be measured using a Immunoglobulin G Luminex Immunoassay (IgG LIA). This Outcome Measure applies only to participants aged 9 to 19 years.

  5. Extension Stage: Seropositivity Rates as Measured by IgG LIA [ Time Frame: Month 12, 24, 36, 48, and 60 ]
    The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 will be assessed. Antibodies will be measured using IgG LIA. This Outcome Measure applies only to participants aged 9 to 19 years.


Secondary Outcome Measures :
  1. Base Stage: Seroconversion Rates as Measured by cLIA [ Time Frame: Month 7 (1 month postdose 3) ]
    The percentage of participants who seroconvert to each of HPV Types 6, 11, 16, and 18 will be assessed. Antibodies will be measured using cLIA.

  2. Base Stage: Antibody Titers as Measured by IgG LIA [ Time Frame: Month 7 (1 month postdose 3) ]
    Geometric mean titers to HPV Types 6, 11, 16, and 18 will be assessed. Antibodies will be measured using IgG LIA.

  3. Base Stage: Seroconversion Rates as Measured by IgG LIA [ Time Frame: Month 7 (1 month postdose 3) ]
    The percentage of participants who seroconvert to each of HPV Types 6, 11, 16, and 18 will be assessed. Antibodies will be measured using IgG LIA.

  4. Base Stage: Solicited Injection-site Adverse Events [ Time Frame: Up to 15 days after any vaccination ]
    The percentage of participants with a solicited injection-site adverse event (AE) will be assessed. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs will include injection-site redness, swelling, induration, pain, and pruritus.

  5. Base Stage: Solicited Systemic Adverse Events [ Time Frame: Up to 15 days after any vaccination ]
    The percentage of participants with a solicited systemic AE will be assessed. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs will include hypersensitivity, headache, fatigue, vomiting, nausea, diarrhea, myalgia, pyrexia, and cough.

  6. Base Stage: Serious Adverse Events [ Time Frame: Up to Month 7 (1 month postdose 3) ]
    The percentage of participants with a Serious Adverse Event (SAE) will be assessed. An SAE is an AE that results in death, is life threatening, requires hospitalization or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, according to medical or scientific judgment, may jeopardize the participant or requires medical or surgical intervention to prevent one of the other outcomes listed in the above definition.

  7. Base Stage: Adverse Events [ Time Frame: Up to 31 days after any vaccination ]
    The percentage of participants with any AE will be assessed. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment

  8. Base Stage: Maximum Axillary Temperature [ Time Frame: Up to 5 days after any vaccination ]
    Maximum axillary temperature reported by participants on the Vaccination Report Card will be summarized.

  9. Extension Stage: Serious Adverse Events [ Time Frame: Up to Month 60 ]
    The percentage of participants with an SAE will be assessed. An SAE is an AE that results in death, is life threatening, requires hospitalization or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, according to medical or scientific judgment, may jeopardize the participant or requires medical or surgical intervention to prevent one of the other outcomes listed in the above definition. This Outcome Measure applies only to participants aged 9 to 19 years.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   9 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Not pregnant and 1) not a woman of childbearing potential (WOCBP), or 2) a WOCBP who has not had sex with males or has had sex with males and used effective contraception since the first day of participant's last menstrual period through Day 1 and understands and agrees that during the study she should not have sexual intercourse with males without effective contraception (the rhythm method, withdrawal, and emergency contraception are not acceptable methods per the protocol).
  • Participant and participant's parent or guardian (participants aged 9-17 years only) provide written informed consent/assent.
  • Provides 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:

  • History of severe allergic reaction that required medical intervention.
  • Allergic to any vaccine component, including aluminum, yeast, or Benzonastem (nuclease).
  • Known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
  • Currently immunocompromised or has been 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.
  • is 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.
  • Is or has 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493542


Locations
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China, Guangdong
Yangchun Center For Disease Prevention And Control ( Site 0003)
Yangchun, Guangdong, China, 529600
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03493542     History of Changes
Other Study ID Numbers: V501-213
V501-213 ( Other Identifier: Merck Protocol Number )
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Adenocarcinoma
Uterine Cervical Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Adenocarcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Vaccines
Immunologic Factors
Physiological Effects of Drugs