Trial · NCT03158220

Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)

NCT03158220, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2019-11-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004). Trials, record NCT03158220. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03158220

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)
NCT number: NCT03158220
Status: Completed
Phases: Phase 3
Enrollment: 1,212 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts, Human Papillomavirus Infection
Interventions: V503
First posted: 2017-05-18
Last updated: 2019-11-21
Results first posted: 2019-11-21

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type	4 weeks post vaccination 3 (Month 7)	Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). Statistical comparisons between arms was performed for the HPV types considered oncogenic (HPV Types 16/18/31/33/45/52/58).
Secondary	Percentage of Participants That Experienced at Least 1 Adverse Event (AE)	Up to 1 month post vaccination 3 (up to 7 months)	An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with 1 or more AEs was assessed.
Secondary	Percentage of Participants Who Had Study Vaccine Discontinued Due to Adverse Event.	Up to 1 month post vaccination 3 (up to 7 months)	An adverse event is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The percentage of participants who discontinued the study vaccine due to an adverse event regardless of study completion status was assessed.
Secondary	Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event	Up to 5 days post any vaccination	Participants were asked to record any injection-site reactions prompted in the Vaccination Report Card, i.e., injection-site tenderness, swelling, or redness, occurring after each study vaccination (solicited injection-site reactions). The percentage of participants with 1 or more solicited injection-site AE was assessed.
Secondary	Percentage of Participants That Reported at Least 1 Systemic Adverse Event	Up to 15 days post any vaccination	An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Systemic AEs are those not categorized as injection-site AEs. The percentage of participants that reported at least 1 systemic AE was assessed
Secondary	Percentage of Participants With Elevated Temperature (Fever)	Up to 5 days post any vaccination	Participants were asked to record oral body temperature in the Vaccination Report Card. The percentage of participants with elevated temperature (≥37.8°C or 100.0°F) was assessed.
Secondary	Percentage of Participants Who Seroconverted to Each of the Anti-HPV Types	4 weeks post vaccination 3 (Month 7)	Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. The percentage of participants who were seronegative on Day 1 and have anti-HPV titer greater or equal to the type-specific serostatus cutoff at 4 weeks postdose 3 was assessed.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type	4 weeks post vaccination 3 (Month 7)	Received all 3 vaccinations of the correct dose and within acceptable day ranges, had evaluable serology results at Day 1 and Month 7, must have been seronegative to the appropriate HPV type at Day 1 and had no protocol deviations that could interfere with the evaluation of participant's immune response to the 9vHPV vaccine.	mMU/mL	GEOMETRIC_MEAN
SECONDARY	Percentage of Participants That Experienced at Least 1 Adverse Event (AE)	Up to 1 month post vaccination 3 (up to 7 months)	All participants that received at least 1 vaccination and had available data for endpoint.	Percentage of Participants	NUMBER
SECONDARY	Percentage of Participants Who Had Study Vaccine Discontinued Due to Adverse Event.	Up to 1 month post vaccination 3 (up to 7 months)	All participants that received at least 1 vaccination and had available data for endpoint.	Percentage of Participants	NUMBER
SECONDARY	Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event	Up to 5 days post any vaccination	All participants that received at least 1 vaccination and had available data for endpoint.	Percentage of Participants	NUMBER
SECONDARY	Percentage of Participants That Reported at Least 1 Systemic Adverse Event	Up to 15 days post any vaccination	All participants that received at least 1 vaccination and had available data for endpoint.	Percentage of Participants	NUMBER
SECONDARY	Percentage of Participants With Elevated Temperature (Fever)	Up to 5 days post any vaccination	All participants that received at least 1 vaccination and had available data for endpoint.	Percentage of Participants	NUMBER
SECONDARY	Percentage of Participants Who Seroconverted to Each of the Anti-HPV Types	4 weeks post vaccination 3 (Month 7)	Received all 3 vaccinations of the correct dose and within acceptable day ranges, had evaluable serology results at Day 1 and Month 7, must have been seronegative to the appropriate HPV type at Day 1 and had no protocol deviations that could interfere with the evaluation of participant's immune response to the 9vHPV vaccine.	Percentage of Participants	NUMBER

Source ClinicalTrials.gov

Results by group46

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type	Women 16-26 Years of Age	Anti-HPV 6	787.8	95% Confidence Interval 732.5 to 847.2	mMU/mL
Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type	Women 27-45 Years of Age	Anti-HPV 6	638.4	95% Confidence Interval 594.9 to 685.0	mMU/mL
Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type	Women 16-26 Years of Age	Anti-HPV 11	598.7	95% Confidence Interval 558.7 to 641.6	mMU/mL
Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type	Women 27-45 Years of Age	Anti-HPV 11	453.5	95% Confidence Interval 424.1 to 485.0	mMU/mL
Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type	Women 16-26 Years of Age	Anti-HPV 16	3075.8	95% Confidence Interval 2863.4 to 3303.9	mMU/mL
Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type	Women 27-45 Years of Age	Anti-HPV 16	2147.5	95% Confidence Interval 2001.1 to 2304.5	mMU/mL
Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type	Women 16-26 Years of Age	Anti-HPV 18	744.5	95% Confidence Interval 685.0 to 809.1	mMU/mL
Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type	Women 27-45 Years of Age	Anti-HPV 18	532.1	95% Confidence Interval 491.8 to 575.7	mMU/mL
Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type	Women 16-26 Years of Age	Anti-HPV 31	596.1	95% Confidence Interval 551.1 to 644.9	mMU/mL
Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type	Women 27-45 Years of Age	Anti-HPV 31	395.7	95% Confidence Interval 367.0 to 426.6	mMU/mL

1 to 10 of 46Source ClinicalTrials.gov

See all 46 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Women 16-26 Years of Age	570
Overall Study	STARTED	Women 27-45 Years of Age	642
Overall Study	Vaccination 1	Women 16-26 Years of Age	570
Overall Study	Vaccination 1	Women 27-45 Years of Age	640
Overall Study	Vaccination 2	Women 16-26 Years of Age	563
Overall Study	Vaccination 2	Women 27-45 Years of Age	635
Overall Study	Vaccination 3	Women 16-26 Years of Age	556
Overall Study	Vaccination 3	Women 27-45 Years of Age	629
Overall Study	COMPLETED	Women 16-26 Years of Age	553
Overall Study	COMPLETED	Women 27-45 Years of Age	626

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events44

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	Nausea	Gastrointestinal disorders	Women 16-26 Years of Age	31	570	35
other	Nausea	Gastrointestinal disorders	Women 27-45 Years of Age	27	640	32
other	Fatigue	General disorders	Women 16-26 Years of Age	28	570	36
other	Fatigue	General disorders	Women 27-45 Years of Age	33	640	42
other	Injection site erythema	General disorders	Women 16-26 Years of Age	112	570	166
other	Injection site erythema	General disorders	Women 27-45 Years of Age	111	640	163
other	Injection site pain	General disorders	Women 16-26 Years of Age	492	570	1,246
other	Injection site pain	General disorders	Women 27-45 Years of Age	532	640	1,244
other	Injection site swelling	General disorders	Women 16-26 Years of Age	137	570	206
other	Injection site swelling	General disorders	Women 27-45 Years of Age	152	640	224

1 to 10 of 44Source ClinicalTrials.gov

See all 44 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Women 16-26 Years of Age	0	570
Total, all-cause mortality	Women 27-45 Years of Age	0	640
Total, other adverse events	Women 16-26 Years of Age	518	570
Total, other adverse events	Women 27-45 Years of Age	574	640
Total, serious adverse events	Women 16-26 Years of Age	6	570
Total, serious adverse events	Women 27-45 Years of Age	8	640

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33676783	DERIVED

Source PubMed

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Women 16-26 Years of Age vs Women 27-45 Years of Age: deaths from any cause	Trial comparisons
Women 16-26 Years of Age vs Women 27-45 Years of Age: serious adverse events	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03158220

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