Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)
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ClinicalTrials.gov Identifier: NCT01651949 |
Recruitment Status :
Completed
First Posted : July 27, 2012
Results First Posted : March 9, 2015
Last Update Posted : November 27, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Genital Warts Anal Cancer Anal Intraepithelial Neoplasia | Biological: 9vHPV Vaccine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2520 participants |
Allocation: | Non-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 9vHPV (V503), a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, in 16- to 26-Year-Old Men and 16- to 26-Year-Old Women |
Actual Study Start Date : | October 29, 2012 |
Actual Primary Completion Date : | August 4, 2014 |
Actual Study Completion Date : | August 4, 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Females
Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
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Biological: 9vHPV Vaccine
9vHPV, V503 (9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine), 0.5 mL injection in 3-dose regimen |
Experimental: Heterosexual Males
Healthy heterosexual males 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
|
Biological: 9vHPV Vaccine
9vHPV, V503 (9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine), 0.5 mL injection in 3-dose regimen |
Experimental: Men who have Sex with Men
Healthy MSM 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
|
Biological: 9vHPV Vaccine
9vHPV, V503 (9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine), 0.5 mL injection in 3-dose regimen |
- Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine [ Time Frame: Four weeks post vaccination 3 (Month 7) ]Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL
- Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card [ Time Frame: Up to 5 days after any vaccination ]An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling. Participants were instructed to use the Vaccination Report Card to record AEs daily after each study vaccination.
- Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F) [ Time Frame: Up to 5 days after any vaccination ]Participants were instructed by the investigator to use the Vaccination Report Card to document evening oral temperature daily after each study vaccination
- Percentage of Participants With an Adverse Event [ Time Frame: Up to Month 12 ]An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.
- Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event [ Time Frame: Up to Month 12 ]An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.
- Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine [ Time Frame: Four weeks post vaccination 3 (Month 7) ]Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Types 33, 45, 52, and 58: ≥8.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 16 Years to 26 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Good physical health
- Has never had Papanicolaou testing (Pap, cervical or anal) or has only had normal Pap test results
- Other inclusion criteria will be discussed with the investigator
Exclusion Criteria:
- History of severe allergic reaction that required medical intervention
- Currently enrolled in a clinical trial
- If participant is female, pregnant
- Currently immunocompromised or having received immunosuppressive therapy in the last year
- Positive test for HPV
- History of HPV-related external genital lesions or HPV-related anal lesions or anal cancer
- If participant is female, history of abnormal cervical biopsy results
- Other exclusion criteria will be discussed with the investigator

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): NCT01651949
Study Director: | Medical Director | Merck Sharp & Dohme Corp. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT01651949 |
Other Study ID Numbers: |
V503-003 2012-002758-22 ( EudraCT Number ) |
First Posted: | July 27, 2012 Key Record Dates |
Results First Posted: | March 9, 2015 |
Last Update Posted: | November 27, 2018 |
Last Verified: | October 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 |
Condylomata Acuminata Anus Neoplasms Neoplasms Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
Anus Diseases Rectal Diseases Warts Papillomavirus Infections DNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Skin Diseases, Viral Tumor Virus Infections Skin Diseases, Infectious Skin Diseases |