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Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam

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: NCT03546842
Recruitment Status : Completed
First Posted : June 5, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study will evaluate the safety and immunogenicity of V503 (GARDASIL™9, 9vHPV vaccine) administered to 9- to 26-year-old females and males in Vietnam. The study hypothesis states that V503 induces acceptable anti-human papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion at 4 weeks postdose 3.

Condition or disease Intervention/treatment Phase
Papillomavirus Infections Uterine Cervical Neoplasms Vulvar Neoplasms Vaginal Neoplasms Adenocarcinoma in Situ Condylomata Acuminata Biological: V503 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase III Open-label Safety and Immunogenicity Study of GARDASIL™9 Administered to 9- to 26-Year-Old Females and Males in Vietnam
Actual Study Start Date : June 29, 2018
Actual Primary Completion Date : January 29, 2019
Actual Study Completion Date : January 29, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: V503
V503 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
Biological: V503
9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine in a 0.5-mL intramuscular injection
Other Names:
  • 9vHPV vaccine
  • GARDASIL™9




Primary Outcome Measures :
  1. Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 [ Time Frame: 4 weeks postdose 3 (Month 7) ]
    Seroconversion is defined as a participant who was anti-HPV seronegative at Day 1 and became seropositive at 4 weeks postdose 3 (Month 7). Anti-HPV antibodies are measured using a Competitive Luminex Immunoassay.


Secondary Outcome Measures :
  1. Percentage of Participants with a Solicited Injection-site Adverse Event [ Time Frame: Up to 5 days after any vaccination ]
    An adverse event (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.

  2. Percentage of Participants with a Solicited Systemic Adverse Event [ Time Frame: Up to 15 days after any vaccination ]
    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.

  3. Percentage of Participants with a Vaccine-related Serious Adverse Event [ Time Frame: Up to 4 weeks postdose 3 (Month 7) ]
    A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine will be determined by the investigator.

  4. Geometric Mean Titers of Serotype-specific Antibodies [ Time Frame: Day 1 (predose) ]
    Anti-HPV Type 6, 11, 16, 18, 31, 33, 45, 52, and 58 antibodies are measured using a Competitive Luminex Immunoassay.

  5. Geometric Mean Titers of Serotype-specific Antibodies [ Time Frame: 4 weeks postdose 3 (Month 7) ]
    Anti-HPV Type 6, 11, 16, 18, 31, 33, 45, 52, and 58 antibodies are measured using a Competitive Luminex Immunoassay.



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

Inclusion Criteria:

  • In good physical health
  • Participants 9 to 15 years of age: has not had coitarche and do not plan on becoming sexually active during the study
  • Participants 16 to 26 year of age: has never had Papanicolaou (Pap) testing or has had only normal Pap test results. Has a lifetime history of ≤4 male and/or female sexual partners.
  • Female participants 16 to 26 years of age: has not had sex with males or has had sex with males and used effective contraception, and understands and agrees that during the study she should not have sexual intercourse with males without effective contraception (rhythm method, withdrawal, and emergency contraception are not acceptable methods of contraception per-protocol).

Exclusion Criteria:

  • Known allergy to any vaccine component, including aluminum, yeast, or BENZONASE™
  • History of severe allergic reaction that required medical intervention
  • Has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
  • Concurrently enrolled in clinical studies of investigational agents
  • Immunocompromised or has been diagnosed with 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
  • Had a splenectomy
  • User of recreational or illicit drugs or has had a recent history (within the last year) of drug abuse or dependence. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems as a result of alcohol use.
  • History of a positive test for HPV
  • Male participants 16 to 26 years of age: history of HPV-related external genital lesions (e.g., condyloma acuminata) or HPV-related anal lesions (e.g., condyloma acuminata, or anal intraepithelial neoplasia) or anal cancer.
  • Female participants 16 to 26 years of age: history of an abnormal cervical biopsy result (showing cervical intraepithelial neoplasia or worse).
  • Female participants 16 to 26 years of age: history of HPV-related external genital lesions (e.g., condyloma acuminata, or vulvar intraepithelial neoplasia) or external genital cancer, HPV-related vaginal lesions (e.g., condyloma acuminata, or vaginal intraepithelial neoplasia) or vaginal cancer, or HPV-related anal lesions (e.g., condyloma acuminata, or anal intraepithelial neoplasia) or anal cancer.
  • Female participants: pregnant as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mIU/mL beta human chorionic gonadotropin (β-hCG).
  • Female participants: expecting to donate eggs during the study.
  • Receiving or has received a prohibited immunosuppressive therapy in the year prior to the study
  • Received any immune globulin product or blood-derived product within the 3 months prior to the Day 1 vaccination, or plans to receive any such product during the study
  • Received inactivated or recombinant vaccines within 14 days prior to the Day 1 vaccination or has received live vaccines within 21 days prior to the Day 1 vaccination
  • Received a marketed HPV vaccine, or has participated in an HPV vaccine clinical study and has received either active agent or placebo
  • Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this study.

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): NCT03546842


Locations
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Vietnam
National Institute of Hygiene and Epidemiology ( Site 0001)
Hanoi, Vietnam, 100000
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: NCT03546842     History of Changes
Other Study ID Numbers: V503-017
2017-001205-33 ( EudraCT Number )
V503-017 ( Other Identifier: Merck Protocol Number )
First Posted: June 5, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 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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Uterine Cervical Diseases
Vaccines
Papillomavirus Infections
Adenocarcinoma
Uterine Cervical Neoplasms
Adenocarcinoma in Situ
Vulvar Neoplasms
Vaginal Neoplasms
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Vulvar Diseases
Vaginal Diseases
Immunologic Factors
Physiological Effects of Drugs