Human Papillomavirus InfectionPhase 3NCT01984697

A Phase III Study of a 2-dose Regimen of a Multivalent Human Papillomavirus (HPV) Vaccine (V503), Administered to 9 to 14 Year-olds and Compared to Young Women, 16 to 26 Years Old (V503-010)

A Phase 3 study testing V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine) in people with Human Papillomavirus Infection, run by Merck Sharp & Dohme LLC.

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

Who is it for?: Ages 9 to 26 yearsHealthy volunteers can take part
Conditions the study is for: Human Papillomavirus Infection
What is being tested?: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,518 participants
Where: No sites listed yet
Study dates: 12 Dec 2013to 24 Jul 2017
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

All Participants:
-Judged to be in good physical health on the basis of medical history, physical examination and laboratory results
Boys and Girls 9 to 14 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

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 10Show 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
Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial

About this study

Official title: A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of a 2-dose Regimen of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Administered in Preadolescents and Adolescents (9 to 14 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)

This was a 37-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 was to establish that the investigational 2-dose regimens (0, 6 months and 0, 12 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 received the standard 3-dose regimen of V503 (i.e., the population and dose regimen used to establish V503 efficacy).

Conditions: Human Papillomavirus Infection
Being tested: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] 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.

V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)Biological
V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection

Study groups in NCT01984697
Study group	Role	What they receive
Girls 9 to 14 Years V503 at Months 0 and 6	Experimental	Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. Receives: Biological: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)
Boys 9 to 14 Years V503 at Months 0 and 6	Experimental	Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. Receives: Biological: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)
Girls and Boys 9 to 14 Years V503 at Months 0 and 12	Experimental	Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36. Receives: Biological: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)
Girls 9 to 14 Years V503 at Months 0, 2, and 6	Experimental	Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants. Receives: Biological: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)
Young Women 16 to 26 Years V503 at Months 0, 2, and 6	Active comparator	Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants. Receives: Biological: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)

What is being measured

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

Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen
Antibodies to HPV virus-like particles (VLP) type 6 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Measured: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Geometric Mean Titers to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Measured: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Geometric Mean Titers to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Measured: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Geometric Mean Titers to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Measured: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Geometric Mean Titers to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Measured: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Geometric Mean Titers to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Measured: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Geometric Mean Titers to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Measured: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Geometric Mean Titers to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Measured: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Geometric Mean Titers to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Measured: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)

Secondary outcomes (9)

Percentage of Participants With Seroconversion to HPV Type 6 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Antibodies to HPV VLP type 6 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 6 was defined as a titer >=30 mMU/mL.
Measured: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Percentage of Participants With Seroconversion to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 11 was defined as a titer >=16 mMU/mL.
Measured: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Percentage of Participants With Seroconversion to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 16 was defined as a titer >=20 mMU/mL.
Measured: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Percentage of Participants With Seroconversion to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 18 was defined as a titer >=24 mMU/mL.
Measured: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Percentage of Participants With Seroconversion to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 31 was defined as a titer >=10 mMU/mL.
Measured: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Percentage of Participants With Seroconversion to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 33 was defined as a titer >=8 mMU/mL.
Measured: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Percentage of Participants With Seroconversion to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 45 was defined as a titer >=8 mMU/mL.
Measured: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Percentage of Participants With Seroconversion to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 52 was defined as a titer >=8 mMU/mL.
Measured: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Percentage of Participants With Seroconversion to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 58 was defined as a titer >=8 mMU/mL.
Measured: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)

Timeline

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

12 Dec 201324 Jul 2017

First posted15 Nov 2013 (estimated)
Study start12 Dec 2013
Primary completion19 Jun 2015
Study completion24 Jul 2017

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 (3)Papers the sponsor has linked to this study.
Other trials for Human Papillomavirus InfectionStudies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,518 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01984697
Sponsor's protocol ID: V503-010
Other IDs: 2013-001314-15, V503-010
Status last verified: Jul 2018
First submitted: 8 Nov 2013
Last updated: 8 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Iversen OE, Miranda MJ, Ulied A, Soerdal T, Lazarus E, Chokephaibulkit K, Block SL, Skrivanek A, Nur Azurah AG, Fong SM, Dvorak V, Kim KH, Cestero RM, Berkovitch M, Ceyhan M, Ellison MC, Ritter MA, Yuan SS, DiNubile MJ, Saah AJ, Luxembourg A. Immunogenicity of the 9-Valent HPV Vaccine Using 2-Dose Regimens in Girls and Boys vs a 3-Dose Regimen in Women. JAMA. 2016 Dec 13;316(22):2411-2421. doi: 10.1001/jama.2016.17615.
PubMed 27893068
Carter JJ, Smith RA, Scherer EM, Skibinski DAG, Sankaranarayanan S, Luxembourg A, Kollmann T, Marty KD, Sadarangani M, Dobson S, Galloway DA. Term immune memory responses to human papillomavirus (HPV) vaccination following 2 versus 3 doses of HPV vaccine. Vaccine. 2025 Mar 19;50:126817. doi: 10.1016/j.vaccine.2025.126817. Epub 2025 Feb 5.
PubMed 39914257
Bornstein J, Roux S, Kjeld Petersen L, Huang LM, Dobson SR, Pitisuttithum P, Diez-Domingo J, Schilling A, Ariffin H, Tytus R, Rupp R, Senders S, Engel E, Ferris D, Kim YJ, Tae Kim Y, Kurugol Z, Bautista O, Nolan KM, Sankaranarayanan S, Saah A, Luxembourg A. Three-Year Follow-up of 2-Dose Versus 3-Dose HPV Vaccine. Pediatrics. 2021 Jan;147(1):e20194035. doi: 10.1542/peds.2019-4035. Epub 2020 Dec 22.
PubMed 33386332

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of a 2-dose Regimen of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Administered in Preadolescents and Adolescents (9 to 14 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)
ClinicalTrials.gov ID: NCT01984697
Acronym / sponsor ID: V503-010
Conditions: Human Papillomavirus Infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,518 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 12 Dec 2013 (actual)
Primary completion: 19 Jun 2015 (actual)
Study completion: 24 Jul 2017 (actual)
First posted: 15 Nov 2013 (estimated)
Results: Posted 26 Apr 2016

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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Girls 9 to 14 Years V503 at Months 0 and 6	Experimental	Biological: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Boys 9 to 14 Years V503 at Months 0 and 6	Experimental	Biological: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls and Boys 9 to 14 Years V503 at Months 0 and 12	Experimental	Biological: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36.
Girls 9 to 14 Years V503 at Months 0, 2, and 6	Experimental	Biological: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
Young Women 16 to 26 Years V503 at Months 0, 2, and 6	Active comparator	Biological: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.

Who may qualify

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

Key inclusion criteria (7 listed)

-Judged to be in good physical health on the basis of medical history, physical examination and laboratory results
-Must not have had coitarche and does not plan on becoming sexually active during the vaccination period
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

Key exclusion criteria (10 listed)

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

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
V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection	Biological	Boys 9 to 14 Years V503 at Months 0 and 6, Girls 9 to 14 Years V503 at Months 0 and 6, Girls 9 to 14 Years V503 at Months 0, 2, and 6, Girls and Boys 9 to 14 Years V503 at Months 0 and 12, Young Women 16 to 26 Years V503 at Months 0, 2, and 6

Primary outcome

Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen
Time frame: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Antibodies to HPV virus-like particles (VLP) type 6 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Time frame: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Time frame: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Time frame: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Time frame: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Time frame: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Time frame: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Time frame: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Time frame: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).

9 secondary outcomes

Percentage of Participants With Seroconversion to HPV Type 6 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Time frame: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Percentage of Participants With Seroconversion to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Time frame: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Percentage of Participants With Seroconversion to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Time frame: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Percentage of Participants With Seroconversion to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Time frame: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Percentage of Participants With Seroconversion to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Time frame: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Percentage of Participants With Seroconversion to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Time frame: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Percentage of Participants With Seroconversion to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Time frame: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Percentage of Participants With Seroconversion to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Time frame: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)
Percentage of Participants With Seroconversion to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen
Time frame: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)

Results and safety

Results posted to the registry on 26 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Girls 9 to 14 Years V503 at Months 0 and 6	301	258
Boys 9 to 14 Years V503 at Months 0 and 6	301	270
Girls and Boys 9 to 14 Years V503 at Months 0 and 12	301	272
Girls 9 to 14 Years V503 at Months 0, 2, and 6	301	280
Young Women 16 to 26 Years V503 at Months 0, 2, and 6	314	279

Primary outcome: Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen

Time frame: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13). Geometric mean (95% Confidence Interval). Unit: mMU/mL

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n = 258	Boys 9 to 14 Years V503 at Months 0 and 6 n = 263	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n = 257	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n = 254	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n = 238
Value	1657.9 (1479.6 to 1857.6)	1557.4 (1391.5 to 1743.1)	2678.8 (2390.2 to 3002.1)	1496.1 (1334.1 to 1677.8)	770.9 (684.8 to 867.9)

Girls 9 to 14 Years V503 at Months 0 and 6 vs Young Women 16 to 26 Years V503 at Months 0, 2, and 6: GMT ratio: 2.15 (95% CI 1.83 to 2.53), p <0.001, ANOVA
Boys 9 to 14 Years V503 at Months 0 and 6 vs Young Women 16 to 26 Years V503 at Months 0, 2, and 6: GMT Ratio: 2.02 (95% CI 1.73 to 2.36), p <0.001, ANOVA
Girls and Boys 9 to 14 Years V503 at Months 0 and 12 vs Young Women 16 to 26 Years V503 at Months 0, 2, and 6: GMT Ratio: 3.47 (95% CI 2.93 to 4.11), p <0.001, ANOVA

Population analysed: All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.

Primary outcome: Geometric Mean Titers to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen

Time frame: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13). Geometric mean (95% Confidence Interval). Unit: mMU/mL

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n = 258	Boys 9 to 14 Years V503 at Months 0 and 6 n = 264	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n = 257	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n = 254	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n = 238
Value	1388.9 (1240.4 to 1555.3)	1423.9 (1273.2 to 1592.3)	2941.8 (2626.6 to 3294.9)	1306.3 (1165.5 to 1464.0)	580.5 (516.0 to 653.0)

Girls 9 to 14 Years V503 at Months 0 and 6 vs Young Women 16 to 26 Years V503 at Months 0, 2, and 6: GMT ratio: 2.39 (95% CI 2.03 to 2.82), p <0.001, ANOVA
Boys 9 to 14 Years V503 at Months 0 and 6 vs Young Women 16 to 26 Years V503 at Months 0, 2, and 6: GMT Ratio: 2.45 (95% CI 2.09 to 2.88), p <0.001, ANOVA
Girls and Boys 9 to 14 Years V503 at Months 0 and 12 vs Young Women 16 to 26 Years V503 at Months 0, 2, and 6: GMT Ratio: 5.07 (95% CI 4.32 to 5.94), p <0.001, ANOVA

Primary outcome: Geometric Mean Titers to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen

Time frame: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13). Geometric mean (95% Confidence Interval). Unit: mMU/mL

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n = 272	Boys 9 to 14 Years V503 at Months 0 and 6 n = 273	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n = 264	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n = 269	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n = 249
Value	8004.9 (7160.5 to 8948.8)	8474.8 (7582.4 to 9472.3)	14329.3 (12796.4 to 16045.9)	6996.0 (6254.1 to 7825.8)	3154.0 (2807.1 to 3543.7)

Girls 9 to 14 Years V503 at Months 0 and 6 vs Young Women 16 to 26 Years V503 at Months 0, 2, and 6: GMT ratio: 2.54 (95% CI 2.14 to 3.00), p <0.001, ANOVA
Boys 9 to 14 Years V503 at Months 0 and 6 vs Young Women 16 to 26 Years V503 at Months 0, 2, and 6: GMT Ratio: 2.69 (95% CI 2.29 to 3.15), p <0.001, ANOVA
Girls and Boys 9 to 14 Years V503 at Months 0 and 12 vs Young Women 16 to 26 Years V503 at Months 0, 2, and 6: GMT Ratio: 4.54 (95% CI 3.84 to 5.37), p <0.001, ANOVA

Primary outcome: Geometric Mean Titers to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen

Time frame: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13). Geometric mean (95% Confidence Interval). Unit: mMU/mL

Measure	Girls 9 to 14 Years V503 at Months 0 and 6 n = 272	Boys 9 to 14 Years V503 at Months 0 and 6 n = 272	Girls and Boys 9 to 14 Years V503 at Months 0 and 12 n = 266	Girls 9 to 14 Years V503 at Months 0, 2, and 6 n = 270	Young Women 16 to 26 Years V503 at Months 0, 2, and 6 n = 267
Value	1872.8 (1651.6 to 2123.6)	1860.9 (1641.1 to 2110.2)	2810.4 (2474.9 to 3191.3)	2049.3 (1806.4 to 2324.8)	761.5 (670.8 to 864.5)

Girls 9 to 14 Years V503 at Months 0 and 6 vs Young Women 16 to 26 Years V503 at Months 0, 2, and 6: GMT ratio: 2.46 (95% CI 2.05 to 2.96), p <0.001, ANOVA
Boys 9 to 14 Years V503 at Months 0 and 6 vs Young Women 16 to 26 Years V503 at Months 0, 2, and 6: GMT Ratio: 2.44 (95% CI 2.04 to 2.92), p <0.001, ANOVA
Girls and Boys 9 to 14 Years V503 at Months 0 and 12 vs Young Women 16 to 26 Years V503 at Months 0, 2, and 6: GMT Ratio: 3.69 (95% CI 3.06 to 4.45), p <0.001, ANOVA

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious Adverse Events: Up to Month 37; Non-injection site adverse events: up to Day 15 following any vaccination; Injection site adverse events: up to Day 5 following any vaccination. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Girls 9 to 14 Years V503 at Months 0 and 6	6 of 294 (2%)	53 of 294 (18%)	0 of 294
Boys 9 to 14 Years V503 at Months 0 and 6	9 of 296 (3%)	32 of 296 (10.8%)	0 of 296
Girls and Boys 9 to 14 Years V503 at Months 0 and 12	6 of 293 (2%)	46 of 293 (15.7%)	0 of 293
Girls 9 to 14 Years V503 at Months 0, 2, and 6	6 of 300 (2%)	55 of 300 (18.3%)	1 of 300
Young Women 16 to 26 Years V503 at Months 0, 2, and 6	11 of 313 (3.5%)	90 of 313 (28.8%)	0 of 313

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27893068Iversen OE, Miranda MJ, Ulied A, Soerdal T, Lazarus E, Chokephaibulkit K, Block SL, Skrivanek A, Nur Azurah AG, Fong SM, Dvorak V, Kim KH, Cestero RM, Berkovitch M, Ceyhan M, Ellison MC, Ritter MA, Yuan SS, DiNubile MJ, Saah AJ, Luxembourg A. Immunogenicity of the 9-Valent HPV Vaccine Using 2-Dose Regimens in Girls and Boys vs a 3-Dose Regimen in Women. JAMA. 2016 Dec 13;316(22):2411-2421. doi: 10.1001/jama.2016.17615.
Derived from this study: PubMed 39914257Carter JJ, Smith RA, Scherer EM, Skibinski DAG, Sankaranarayanan S, Luxembourg A, Kollmann T, Marty KD, Sadarangani M, Dobson S, Galloway DA. Term immune memory responses to human papillomavirus (HPV) vaccination following 2 versus 3 doses of HPV vaccine. Vaccine. 2025 Mar 19;50:126817. doi: 10.1016/j.vaccine.2025.126817. Epub 2025 Feb 5.
Derived from this study: PubMed 33386332Bornstein J, Roux S, Kjeld Petersen L, Huang LM, Dobson SR, Pitisuttithum P, Diez-Domingo J, Schilling A, Ariffin H, Tytus R, Rupp R, Senders S, Engel E, Ferris D, Kim YJ, Tae Kim Y, Kurugol Z, Bautista O, Nolan KM, Sankaranarayanan S, Saah A, Luxembourg A. Three-Year Follow-up of 2-Dose Versus 3-Dose HPV Vaccine. Pediatrics. 2021 Jan;147(1):e20194035. doi: 10.1542/peds.2019-4035. Epub 2020 Dec 22.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine) in people with Human Papillomavirus Infection, run by Merck Sharp & Dohme LLC.

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 10 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 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

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 26 Apr 2016). 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?

Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen (time frame: 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)). The study lists 9 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 NCT01984697, which also lists 3 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 8 Aug 2018; AzTrials last refreshed its copy on 3 Nov 2026.