Trial · NCT01651949
Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)
NCT01651949, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2015-03-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003). Trials, record NCT01651949. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01651949
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)
- NCT number
- NCT01651949
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,520 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Genital Warts, Anal Cancer, Anal Intraepithelial Neoplasia
- Interventions
- 9vHPV Vaccine
- First posted
- 2012-07-27
- Last updated
- 2018-11-27
- Other registries' IDs
- eudract:2012-002758-22
- Results first posted
- 2015-03-09
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | 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 |
| Primary | Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card | 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. |
| Primary | Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F) | 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 |
| Primary | Percentage of Participants With an Adverse Event | 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. |
| Primary | Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event | 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. |
| Secondary | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Four weeks post vaccination 3 (Month 7) | The analysis set includes heterosexual male and female participants who received the 3 vaccinations, were seronegative to the appropriate HPV type at baseline, and had Month 7 immunogenicity results for the appropriate HPV type. Per-protocol non-inferiority analysis compared heterosexual males and females only. | milli Merck Units/mL | GEOMETRIC_MEAN |
| PRIMARY | Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card | Up to 5 days after any vaccination | The analysis set includes all participants who received \>=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F) | Up to 5 days after any vaccination | The analysis set includes all participants who received \>=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine | Four weeks post vaccination 3 (Month 7) | The analysis set includes participants who received the 3 vaccinations, were seronegative to the appropriate HPV type at baseline, and had Month 7 immunogenicity results for the appropriate HPV type. Per-protocol non-inferiority analysis compared heterosexual males and females only. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With an Adverse Event | Up to Month 12 | The analysis set includes all participants who received \>=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event | Up to Month 12 | The analysis set includes all participants who received \>=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Heterosexual Males | Anti-HPV Type 6 (n=847, 708, 164) | 782.0 | 95% Confidence Interval 738.0 to 828.7 | milli Merck Units/mL |
| Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Females | Anti-HPV Type 6 (n=847, 708, 164) | 703.9 | 95% Confidence Interval 660.6 to 749.9 | milli Merck Units/mL |
| Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Men Who Have Sex With Men | Anti-HPV Type 6 (n=847, 708, 164) | 568.9 | 95% Confidence Interval 498.7 to 649.0 | milli Merck Units/mL |
| Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Heterosexual Males | Anti-HPV Type 11 (n=851, 712, 165) | 616.7 | 95% Confidence Interval 582.4 to 653.0 | milli Merck Units/mL |
| Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Females | Anti-HPV Type 11 (n=851, 712, 165) | 564.9 | 95% Confidence Interval 530.6 to 601.3 | milli Merck Units/mL |
| Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Men Who Have Sex With Men | Anti-HPV Type 11 (n=851, 712, 165) | 437.7 | 95% Confidence Interval 384.4 to 498.5 | milli Merck Units/mL |
| Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Heterosexual Males | Anti-HPV Type 16 (n=899, 781, 212) | 3346.0 | 95% Confidence Interval 3158.9 to 3544.1 | milli Merck Units/mL |
| Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Females | Anti-HPV Type 16 (n=899, 781, 212) | 2788.3 | 95% Confidence Interval 2621.4 to 2965.8 | milli Merck Units/mL |
| Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Men Who Have Sex With Men | Anti-HPV Type 16 (n=899, 781, 212) | 2294.0 | 95% Confidence Interval 2037.8 to 2582.5 | milli Merck Units/mL |
| Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine | Heterosexual Males | Anti-HPV Type 18 (n=906, 831, 220) | 808.2 | 95% Confidence Interval 754.9 to 865.4 | milli Merck Units/mL |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Heterosexual Males | 1,106 | |
| Overall Study | STARTED | Females | 1,101 | |
| Overall Study | STARTED | Men Who Have Sex With Men (MSM) | 313 | |
| Overall Study | Vaccination 1 | Heterosexual Males | 1,103 | |
| Overall Study | Vaccination 1 | Females | 1,099 | |
| Overall Study | Vaccination 1 | Men Who Have Sex With Men (MSM) | 313 | |
| Overall Study | Vaccination 2 | Heterosexual Males | 1,089 | |
| Overall Study | Vaccination 2 | Females | 1,069 | |
| Overall Study | Vaccination 2 | Men Who Have Sex With Men (MSM) | 298 | |
| Overall Study | Vaccination 3 | Heterosexual Males | 1,067 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events88
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site erythema | General disorders | Heterosexual and MSM Males | 291 | 1,394 | 422 |
| other | Injection site erythema | General disorders | Females | 348 | 1,075 | 539 |
| other | Injection site pain | General disorders | Heterosexual and MSM Males | 886 | 1,394 | 1,877 |
| other | Injection site pain | General disorders | Females | 893 | 1,075 | 2,101 |
| other | Injection site swelling | General disorders | Heterosexual and MSM Males | 285 | 1,394 | 431 |
| other | Injection site swelling | General disorders | Females | 408 | 1,075 | 661 |
| other | Headache | Nervous system disorders | Heterosexual and MSM Males | 200 | 1,394 | 271 |
| other | Headache | Nervous system disorders | Females | 246 | 1,075 | 378 |
| serious | Atrioventricular block second degree | Cardiac disorders | Heterosexual and MSM Males | 1 | 1,394 | 1 |
| serious | Atrioventricular block second degree | Cardiac disorders | Females | 0 | 1,075 | 0 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Heterosexual and MSM Males | ||
| Total, all-cause mortality | Females | ||
| Total, other adverse events | Heterosexual and MSM Males | 976 | 1,394 |
| Total, other adverse events | Females | 924 | 1,075 |
| Total, serious adverse events | Heterosexual and MSM Males | 23 | 1,394 |
| Total, serious adverse events | Females | 26 | 1,075 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Heterosexual and MSM Males vs Females: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01651949
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