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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 (V503-017)

Primary Purpose

Papillomavirus Infections, Uterine Cervical Neoplasms, Vulvar Neoplasms

Status

Completed

Phase

Phase 3

Locations

Vietnam

Study Type

Interventional

Intervention

9vHPV vaccine

About this trial

This is an interventional prevention trial for Papillomavirus Infections

Eligibility Criteria

9 Years - 26 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

National Institute of Hygiene and Epidemiology ( Site 0001)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

9vHPV vaccine

Arm Description

Participants will receive a single 0.5-mL intramuscular injection of the 9vHPV vaccine at Day 1, Month 2, and Month 6

Outcomes

Primary Outcome Measures

Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7

Seroconversion was 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 were measured using a Competitive Luminex Immunoassay.

Secondary Outcome Measures

Percentage of Participants With a Solicited Injection-site Adverse Event

An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study vaccine. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study vaccine or protocol-specified procedure was also an AE. The participant or the parent/guardian of the participant were to record the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 5 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) was summarized.

Percentage of Participants With a Solicited Systemic Adverse Event

An AE was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study vaccine. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study vaccine or protocol-specified procedure was also an AE. The only solicited systemic AE was in response to results of daily oral temperature assessments. The participant or the parent/guardian of the participant will be asked to record the participant's oral temperature in the evening after each study vaccination and daily for 4 days after each study vaccination on VRC. The percentage of participants that had an AE due to an elevated oral temperature [(≥ 37.8 °C (100.0 °F)] was summarized.

Percentage of Participants With a Vaccine-related Serious Adverse Event

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. The percentage of participants that experience at least one SAE that was reported as at least possibly related to the study vaccine was summarized.

Geometric Mean Titers of Serotype-specific Antibodies: Predose Day 1

Anti-HPV Type 6, 11, 16, 18, 31, 33, 45, 52, and 58 antibodies are measured using a Competitive Luminex Immunoassay. Titers are reported in milli Merck units/mL (mMU/mL).

Geometric Mean Titers of Antibodies to HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7

Anti-HPV Type 6, 11, 16, 18, 31, 33, 45, 52, and 58 antibodies are measured using a Competitive Luminex Immunoassay. Titers are reported in mMU/mL.

Full Information

NCT ID

NCT03546842

First Posted

May 23, 2018

Last Updated

February 14, 2020

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT03546842

Brief Title

Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam (V503-017)

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

June 29, 2018 (Actual)

Primary Completion Date

January 29, 2019 (Actual)

Study Completion Date

January 29, 2019 (Actual)

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

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Papillomavirus Infections, Uterine Cervical Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Adenocarcinoma in Situ, Condylomata Acuminata

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

201 (Actual)

8. Arms, Groups, and Interventions

Arm Title

9vHPV vaccine

Arm Type

Experimental

Arm Description

Participants will receive a single 0.5-mL intramuscular injection of the 9vHPV vaccine at Day 1, Month 2, and Month 6

Intervention Type

Biological

Intervention Name(s)

9vHPV vaccine

Other Intervention Name(s)

V503, GARDASIL™9

Intervention Description

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

Primary Outcome Measure Information:

Title

Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7

Description

Time Frame

4 weeks postdose 3 (Month 7)

Secondary Outcome Measure Information:

Title

Percentage of Participants With a Solicited Injection-site Adverse Event

Description

Time Frame

Up to 5 days after any vaccination

Title

Percentage of Participants With a Solicited Systemic Adverse Event

Description

Time Frame

Up to 5 days after any vaccination

Title

Percentage of Participants With a Vaccine-related Serious Adverse Event

Description

Time Frame

Up to 4 weeks postdose 3 (Month 7)

Title

Geometric Mean Titers of Serotype-specific Antibodies: Predose Day 1

Description

Anti-HPV Type 6, 11, 16, 18, 31, 33, 45, 52, and 58 antibodies are measured using a Competitive Luminex Immunoassay. Titers are reported in milli Merck units/mL (mMU/mL).

Time Frame

Day 1 (predose)

Title

Geometric Mean Titers of Antibodies to HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7

Description

Anti-HPV Type 6, 11, 16, 18, 31, 33, 45, 52, and 58 antibodies are measured using a Competitive Luminex Immunoassay. Titers are reported in mMU/mL.

Time Frame

4 weeks postdose 3 (Month 7)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

26 Years

Accepts Healthy Volunteers

Eligibility 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.

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

National Institute of Hygiene and Epidemiology ( Site 0001)

City

Hanoi

ZIP/Postal Code

100000

Country

Vietnam

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

Citations:

PubMed Identifier

33844623

Citation

Thiem VD, Quang ND, Tuan NH, Cheon K, Gallagher N, Luxembourg A, Group T, Badshah C. Immunogenicity and safety of a nine-valent human papillomavirus vaccine in Vietnamese males and females (9 to 26 years of age): an open-label, phase 3 trial. Hum Vaccin Immunother. 2021 Jul 3;17(7):1980-1985. doi: 10.1080/21645515.2020.1865739. Epub 2021 Apr 12.

Results Reference

derived

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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 (V503-017)

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