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Papillomavirus InfectionsPhase 3NCT04708041

Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)

A Phase 3 study testing 9vHPV vaccine in people with Papillomavirus Infections, run by Merck Sharp & Dohme LLC at 30 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a 96-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age. From this study, the goal is to establish that the investigational extended 2-dose regimens (0, 12 months; 0, 24 months; 0, 36 months; and 0, 60 months) studied in boys and… 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
What is being tested?
9vHPV vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
30 sitesin 6 countries
Study dates
15 Mar 2021to 23 Oct 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Boys and Girls 9 to 15 Years:
  • Must not have had coitarche and does not plan on becoming sexually active during the vaccination period
  • Women 16 to 26 Years:
  • Has never had a Papanicolaou (Pap) test or only had normal Pap test results
  • A lifetime history of 0 to 4 male and/or female sexual partners
  • Cohort 0 Participants:
  • Received 1 dose of 9vHPV vaccine at least 1 year prior to enrollment and did not receive a second dose of any HPV vaccine

Who cannot join

  • All Participants:
  • Known allergy to any vaccine component
  • History of severe allergic reaction that required medical intervention
  • Thrombocytopenia or any coagulation disorder
  • Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7
  • Currently immunocompromised, or been diagnosed with immunodeficiency
Show all 11Show fewer
  • Had a splenectomy
  • Receiving or has received immunosuppressive therapies within the last year
  • Received any immunoglobulin product or blood-derived product within 3 months
  • Has received more than 1 dose of an HPV vaccine (Cohort 0)
  • Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial (Cohorts 1-5)

Trial locations and contacts

30 sites in 6 countries.

30 sites in 6 countries

United States14 sites

  • MultiCare Rockwood Cheney Clinic ( Site 0038)

    Cheney, Washington, 99004

  • Coastal Bend Clinical Research ( Site 0025)

    Corpus Christi, Texas, 78413

  • Kaiser Permanente Daly City ( Site 0044)

    Daly City, California, 94015

  • University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si

    Galveston, Texas, 77555

  • Tribe Clinical Research, LLC ( Site 0010)

    Greenville, South Carolina, 29607

  • Advanced Research for Health Improvement, LLC-Pediatrics ( Site 0007)

    Naples, Florida, 34102

  • Coastal Carolina Research Center ( Site 0032)

    North Charleston, South Carolina, 29405

  • Kaiser Permanente Oakland ( Site 0020)

    Oakland, California, 94611

  • Kaiser Permanente Roseville ( Site 0047)

    Roseville, California, 95661

  • Kaiser Permanente Sacramento ( Site 0043)

    Sacramento, California, 95815

  • Kaiser Permanente South Sacramento ( Site 0045)

    Sacramento, California, 95823

  • Kaiser Permanente San Jose ( Site 0046)

    San Jose, California, 95119

  • Kaiser Permanente Santa Clara ( Site 0042)

    Santa Clara, California, 95051

  • Encompass Clinical Research ( Site 0022)

    Spring Valley, California, 91978

Other trials in United States

Mexico4 sites

  • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan (

    Mérida, Yucatán, 97130

  • CAIMED México ( Site 0207)

    Mexico City, Mexico City, 06760

  • Unidad biomedica avanzada monterrey ( Site 0203)

    Monterrey, Nuevo León, 64460

  • AINPAD ( Site 0204)

    Morelia, Michoacán, 58350

Other trials in Mexico

Poland4 sites

  • Jerzy Brzostek Prywatny Gabinet Lekarski ( Site 0553)

    Dębica, Podkarpackie Voivodeship, 39-200

  • Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 0555)

    Lodz, Łódź Voivodeship, 91-347

  • ALERGO-MED Specjalistyczna Przychodnia Lekarska ( Site 0557)

    Tarnów, Lesser Poland Voivodeship, 33-100

  • Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 0556)

    Wroclaw, Lower Silesian Voivodeship, 50-369

Other trials in Poland

South Africa3 sites

  • TREAD Research ( Site 0354)

    Cape Town, Western Cape, 7500

  • Desmond Tutu HIV Foundation ( Site 0355)

    Cape Town, Western Cape, 7795

  • Perinatal HIV Research Unit_Do not use - Duplicate facility ( Site 0351)

    Johannesburg, Gauteng, 1864

Other trials in South Africa

Taiwan3 sites

  • Taichung Veterans General Hospital ( Site 0653)

    Taichung, 407

  • National Taiwan University Hospital ( Site 0651)

    Taipei, 10002

  • Chang Gung Medical Foundation.Linkou Branch ( Site 0652)

    Taoyuan, 333

Other trials in Taiwan

Colombia2 sites

  • Centro de Atención e Investigación Médica SAS - CAIMED CHIA ( Site 0151)

    Chía, Cundinamarca, 250001

  • Fundación Centro de Investigación Clínica CIC ( Site 0157)

    Medellín, Antioquia, 050021

Other trials in Colombia

About this study

Official title: A Phase 3 International, Multicenter, Open-label Study to Evaluate the Safety and Immunogenicity of 9vHPV Vaccine Administered as 2-dose Regimen With Extended Dosing Intervals in 9- to 14-Year Old Boys and Girls Compared With a Standard 3-dose Regimen in 16- to 26-Year Old Women

This is a 96-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age. From this study, the goal is to establish that the investigational extended 2-dose regimens (0, 12 months; 0, 24 months; 0, 36 months; and 0, 60 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that is not inferior to that observed in young women 16 to 26 years of age who receive the standard 3-dose regimen of 9-valent human papillomavirus (9vHPV) vaccine at 0, 2, and 6 months (i.e., the population and dose regimen used to establish 9vHPV vaccine efficacy).

Being tested
9vHPV vaccine
Medical subject headings
Papillomavirus Infections

What participants receive

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

  • 9vHPV vaccineBiological

    9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection

Study groups in NCT04708041
Study groupRoleWhat they receive
Cohort 0: 1 Dose of 9vHPV Vaccine (previous 1-dose recipients)Experimental10 to 15 year old girls and boys (who previously received 1 dose of 9vHPV vaccine) receive a second dose of 9vHPV vaccine at Day 1.
Receives: Biological: 9vHPV vaccine
Cohort 1: 2 Doses of 9vHPV Vaccine Given 12 Months ApartExperimental9 to 14 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 12.
Receives: Biological: 9vHPV vaccine
Cohort 2: 2 Doses of 9vHPV Vaccine Given 24 Months ApartExperimental9 to 13 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Months 24.
Receives: Biological: 9vHPV vaccine
Cohort 3: 2 Doses of 9vHPV Vaccine Given 36 Months ApartExperimental9 to 12 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 36.
Receives: Biological: 9vHPV vaccine
Cohort 4: 2 Doses of 9vHPV Vaccine Given 60 Months ApartExperimental9 to 10 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 60.
Receives: Biological: 9vHPV vaccine
Cohort 5: 3 Doses of 9vHPV Vaccine Given Over a 6-Month PeriodActive comparator16 to 26 year old young women receive 3 dose regimen of 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.

  1. Geometric Mean Titers of Anti-Human Papilloma Virus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 as Measured by Competitive Luminex Immunoassay

    Serum antibody titers for human papilloma virus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using competitive luminex immunoassay (cLIA). The geometric mean titer (GMT) for each HPV type will be reported in milli Merck units/mL (mMU/mL).

    Measured: 4 weeks post last vaccination (Up to ~Month 61)

  2. Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event

    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with injection-site AEs (erythema/redness, pain and swelling) will be assessed.

    Measured: Up to 5 days post vaccination

  3. Percentage of Participants With at Least 1 Systemic Adverse Event

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with a systemic AE will be assessed.

    Measured: Up to 15 days post vaccination

  4. Percentage of Participants With at Least 1 Serious Vaccine-Related Adverse Event

    A serious adverse event (SAE) is defined as one that results in death, is life threatening, or requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical event that may require medical intervention. An SAE that is judged by the investigator to be related to the study vaccine is defined as a vaccine-related SAE.

    Measured: Entire study period (Up to ~Month 96)

Secondary outcomes (7)

  1. Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58

    Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The percentage of participants who are seropositive (analysis population Cohorts 1 through 5 only) for each HPV type will be assessed.

    Measured: 4 weeks post last vaccination

  2. Geometric Mean Titers (Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58

    Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The GMT for each HPV type (analysis population Cohorts 1 through 5 only) will be reported in mMU/mL.

    Measured: 12 months post last vaccination

  3. Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58

    Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The percentage of participants who are seropositive (analysis population Cohorts 1 through 5 only) for each HPV type will be assessed.

    Measured: 12 months post last vaccination

  4. Geometric Mean Titers ( Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58

    Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The GMT for each HPV type (analysis population Cohorts 1 through 5 only) will be reported in mMU/mL.

    Measured: 24 months post last vaccination

  5. Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58

    Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The percentage of participants who are seropositive (analysis population Cohorts 1 through 5 only) for each HPV type will be assessed.

    Measured: 24 months post last vaccination

  6. Geometric Mean Titers ( Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52 , and 58

    Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The GMT for each HPV type (analysis population Cohorts 1 through 5 only) will be reported in mMU/mL.

    Measured: 36 months post last vaccination

  7. Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58

    Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using cLIA. The percentage of participants who are seropositive (analysis population Cohorts 1 through 5 only) for each HPV type will be assessed.

    Measured: 36 months post last vaccination

Timeline

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

  1. First posted13 Jan 2021
  2. Study start15 Mar 2021
  3. Primary completion23 Oct 2029 (estimated)
  4. Study completion23 Oct 2029 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04708041
Sponsor's protocol ID
V503-069
Other IDs
V503-069, 2022-500253-37, U1111-1274-2496, 2020-003736-24
Status last verified
Apr 2025
First submitted
12 Jan 2021
Last updated
20 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Teppler H, Bautista O; Thomas Group; Flores S, McCauley J, Luxembourg A. Design of a Phase III immunogenicity and safety study evaluating two-dose regimens of 9-valent human papillomavirus (9vHPV) vaccine with extended dosing intervals. Contemp Clin Trials. 2021 Jun;105:106403. doi: 10.1016/j.cct.2021.106403. Epub 2021 Apr 12.

    PubMed 33857679

  • Klein NP, Wiesner A, Bautista O, Group T, Kanu K, Li ZL, McCauley J, Saxena K, Tota J, Luxembourg A, Bonawitz R. Immunogenicity and Safety of Extended-Interval 2-Dose Regimens of 9vHPV Vaccine. Pediatrics. 2024 Aug 1;154(2):e2023064693. doi: 10.1542/peds.2023-064693.

    PubMed 38978512

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 9vHPV vaccine in people with Papillomavirus Infections, run by Merck Sharp & Dohme LLC at 30 sites in 6 countries.

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 7 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Mexico, Poland, South Africa, Taiwan and 1 more country. 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?

This study is still under way. Results are not available in the source record yet.

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?

Geometric Mean Titers of Anti-Human Papilloma Virus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 as Measured by Competitive Luminex Immunoassay (time frame: 4 weeks post last vaccination (Up to ~Month 61)). The study lists 4 primary outcomes in all. 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 NCT04708041, which also lists 2 linked publications.

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 20 Apr 2025.

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