Papillomavirus InfectionsPhase 3NCT03546842

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

A Phase 3 study testing 9vHPV vaccine in people with Papillomavirus Infections and Uterine Cervical Neoplasms, run by Merck Sharp & Dohme LLC at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 9 to 26 yearsHealthy volunteers can take part
Conditions the study is for: Papillomavirus Infections, Uterine Cervical Neoplasms, Vulvar Neoplasms
What is being tested?: 9vHPV vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 201 participants
Where: 1 siteVietnam
Study dates: 29 Jun 2018to 29 Jan 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 to 26 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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).

Who cannot join

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

Show all 18Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

National Institute of Hygiene and Epidemiology ( Site 0001)
Hanoi, 100000

Other trials in Vietnam

About this study

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

Conditions: Papillomavirus Infections, Uterine Cervical Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Adenocarcinoma in Situ, Condylomata Acuminata
Being tested: 9vHPV vaccine
Medical subject headings: Papillomavirus Infections, Uterine Cervical Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Adenocarcinoma in Situ, Condylomata Acuminata

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

9vHPV vaccineBiological
Also called V503, GARDASIL™9
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

Study groups in NCT03546842
Study group	Role	What they receive
9vHPV vaccine	Experimental	Participants will receive a single 0.5-mL intramuscular injection of the 9vHPV vaccine at Day 1, Month 2, and Month 6 Receives: Biological: 9vHPV vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 4 weeks postdose 3 (Month 7)

Secondary outcomes (5)

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.
Measured: Up to 5 days after any vaccination
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.
Measured: Up to 5 days after any vaccination
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.
Measured: Up to 4 weeks postdose 3 (Month 7)
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).
Measured: Day 1 (predose)
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.
Measured: 4 weeks postdose 3 (Month 7)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jun 201829 Jan 2019

First posted6 Jun 2018
Study start29 Jun 2018
Primary completion29 Jan 2019
Study completion29 Jan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Papillomavirus InfectionsStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 201 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03546842
Sponsor's protocol ID: V503-017
Other IDs: 2017-001205-33, V503-017, 2017
Status last verified: Feb 2020
First submitted: 23 May 2018
Last updated: 25 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

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.
PubMed 33844623

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03546842
Acronym / sponsor ID: V503-017
Conditions: Papillomavirus Infections, Uterine Cervical Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Adenocarcinoma in Situ, Condylomata Acuminata
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 201 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 29 Jun 2018 (actual)
Primary completion: 29 Jan 2019 (actual)
Study completion: 29 Jan 2019 (actual)
First posted: 6 Jun 2018 (actual)
Results: Posted 5 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
9vHPV vaccine	Experimental	Biological: 9vHPV vaccineParticipants will receive a single 0.5-mL intramuscular injection of the 9vHPV vaccine at Day 1, Month 2, and Month 6

Who may qualify

Ages: 9 to 26 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (18 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
9vHPV vaccineAlso: V503, GARDASIL™99-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	Biological	9vHPV vaccine

Primary outcome

Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7
Time frame: 4 weeks postdose 3 (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.

5 secondary outcomes

Percentage of Participants With a Solicited Injection-site Adverse Event
Time frame: Up to 5 days after any vaccination
Percentage of Participants With a Solicited Systemic Adverse Event
Time frame: Up to 5 days after any vaccination
Percentage of Participants With a Vaccine-related Serious Adverse Event
Time frame: Up to 4 weeks postdose 3 (Month 7)
Geometric Mean Titers of Serotype-specific Antibodies: Predose Day 1
Time frame: Day 1 (predose)
Geometric Mean Titers of Antibodies to HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7
Time frame: 4 weeks postdose 3 (Month 7)

Results and safety

Results posted to the registry on 5 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
9vHPV Vaccine	201	198

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

Time frame: 4 weeks postdose 3 (Month 7). Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	9vHPV Vaccine n = 195
Anti-HPV 6	100 (98.1 to 100.0)
Anti-HPV 11	100 (98.1 to 100.0)
Anti-HPV 16	100 (98.0 to 100.0)
Anti-HPV 18	100.0 (98.1 to 100.0)
Anti-HPV 31	100.0 (98.1 to 100.0)
Anti-HPV 33	100.0 (98.1 to 100.0)
Anti-HPV 45	100.0 (98.1 to 100.0)
Anti-HPV 52	100.0 (98.1 to 100.0)

Population analysed: All allocated participants who were seronegative to the appropriate HPV type at Day 1, received all 3 vaccinations with the correct dose within acceptable day ranges, provided a serum sample within 21 to 49 days postdose 3, and had no protocol deviations that could interfere with the evaluation of participant's immune response to 9vHPV vaccination.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 4 weeks postdose 3 (Month 7). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
9vHPV Vaccine	1 of 200 (0.5%)	90 of 200 (45%)	0 of 201

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33844623Thiem 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.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 9vHPV vaccine in people with Papillomavirus Infections and Uterine Cervical Neoplasms, run by Merck Sharp & Dohme LLC at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7 (time frame: 4 weeks postdose 3 (Month 7)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03546842, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.