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)
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ClinicalTrials.gov Identifier: NCT01984697 |
Recruitment Status :
Completed
First Posted : November 15, 2013
Results First Posted : April 26, 2016
Last Update Posted : August 8, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Human Papillomavirus Infection | Biological: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1518 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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) |
Actual Study Start Date : | December 12, 2013 |
Actual Primary Completion Date : | June 19, 2015 |
Actual Study Completion Date : | July 24, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Girls 9 to 14 Years V503 at Months 0 and 6
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.
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Biological: 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 |
Experimental: Boys 9 to 14 Years V503 at Months 0 and 6
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.
|
Biological: 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 |
Experimental: Girls and Boys 9 to 14 Years V503 at Months 0 and 12
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.
|
Biological: 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 |
Experimental: Girls 9 to 14 Years V503 at Months 0, 2, and 6
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.
|
Biological: 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 |
Active Comparator: Young Women 16 to 26 Years V503 at Months 0, 2, and 6
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.
|
Biological: 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 |
- 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).
- 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) ]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.
- 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) ]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.
- 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) ]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.
- 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) ]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.
- 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) ]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.
- 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) ]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.
- 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) ]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.
- 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) ]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.
- 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) ]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.
- Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24 [ Time Frame: Month 24 ]Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
- Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24 [ Time Frame: Month 24 ]Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Seroconversion to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were defined as a titer >=41, 24, 34, 39, 24, 18, 12, 16, and 12 mMU/mL, respectively. These cutoffs differ from analyses performed on samples collected up to Month 13; the antibody persistence analysis employed a new version of the assay.
- Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36 [ Time Frame: Month 36 ]Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
- Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36 [ Time Frame: Month 36 ]Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Seroconversion to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were defined as a titer >=41, 24, 34, 39, 24, 18, 12, 16, and 12 mMU/mL, respectively. These cutoffs differ from analyses performed on samples collected up to Month 13; the antibody persistence analysis employed a new version of the assay.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01984697
Study Director: | Medical Director | Merck Sharp & Dohme LLC |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Merck Sharp & Dohme LLC |
ClinicalTrials.gov Identifier: | NCT01984697 |
Other Study ID Numbers: |
V503-010 2013-001314-15 ( EudraCT Number ) V503-010 ( Other Identifier: Merck Protocol Number ) |
First Posted: | November 15, 2013 Key Record Dates |
Results First Posted: | April 26, 2016 |
Last Update Posted: | August 8, 2018 |
Last Verified: | July 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf |
URL: | http://engagezone.msd.com/ds_documentation.php |
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