Who is sponsoring NCT01984697?

NCT01984697 is sponsored by Merck Sharp & Dohme LLC.

What drugs are being tested in NCT01984697?

Interventions in NCT01984697: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine).

What condition does NCT01984697 study?

NCT01984697 studies Human Papillomavirus Infection.

Is NCT01984697 still recruiting?

NCT01984697 is currently completed. Last updated 8 August 2018.

Are results published for NCT01984697?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-08-08 · How we verify

NCT01984697

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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)

Completed Phase 3 Results posted Last updated 8 August 2018

What this trial tests

Phase 3 trial testing V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine) in Human Papillomavirus Infection in 1,518 participants. Completed in 24 July 2017.

Timeline

12 December 2013

Primary endpoint
19 June 2015

24 July 2017

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,518
Start date	12 December 2013
Primary completion	19 June 2015
Estimated completion	24 July 2017

Drugs / interventions tested

V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine) — full drug profile →

Conditions studied

Human Papillomavirus Infection — all drugs for Human Papillomavirus Infection →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 9 to 26, any sex, with Human Papillomavirus Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Girls 9 to 14 Years V503 at Months 0 and 6	1657.9	1479.6 – 1857.6
Boys 9 to 14 Years V503 at Months 0 and 6	1557.4	1391.5 – 1743.1
Girls and Boys 9 to 14 Years V503 at Months 0 and 12	2678.8	2390.2 – 3002.1
Girls 9 to 14 Years V503 at Months 0, 2, and 6	1496.1	1334.1 – 1677.8
Young Women 16 to 26 Years V503 at Months 0, 2, and 6	770.9	684.8 – 867.9

Percentage of Participants With Seroconversion to HPV Type 6 at Four Weeks After the Last Dose of V503 in the Planned Regimen Secondary · 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.

Group	Value	95% CI
Girls 9 to 14 Years V503 at Months 0 and 6	99.6	97.9 – 100
Boys 9 to 14 Years V503 at Months 0 and 6	100	98.6 – 100
Girls and Boys 9 to 14 Years V503 at Months 0 and 12	100	98.6 – 100
Girls 9 to 14 Years V503 at Months 0, 2, and 6	99.2	97.2 – 99.9
Young Women 16 to 26 Years V503 at Months 0, 2, and 6	99.6	97.7 – 100

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

Group	Value	95% CI
Girls 9 to 14 Years V503 at Months 0 and 6	1388.9	1240.4 – 1555.3
Boys 9 to 14 Years V503 at Months 0 and 6	1423.9	1273.2 – 1592.3
Girls and Boys 9 to 14 Years V503 at Months 0 and 12	2941.8	2626.6 – 3294.9
Girls 9 to 14 Years V503 at Months 0, 2, and 6	1306.3	1165.5 – 1464.0
Young Women 16 to 26 Years V503 at Months 0, 2, and 6	580.5	516.0 – 653.0

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

Group	Value	95% CI
Girls 9 to 14 Years V503 at Months 0 and 6	8004.9	7160.5 – 8948.8
Boys 9 to 14 Years V503 at Months 0 and 6	8474.8	7582.4 – 9472.3
Girls and Boys 9 to 14 Years V503 at Months 0 and 12	14329.3	12796.4 – 16045.9
Girls 9 to 14 Years V503 at Months 0, 2, and 6	6996.0	6254.1 – 7825.8
Young Women 16 to 26 Years V503 at Months 0, 2, and 6	3154.0	2807.1 – 3543.7

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

Group	Value	95% CI
Girls 9 to 14 Years V503 at Months 0 and 6	1872.8	1651.6 – 2123.6
Boys 9 to 14 Years V503 at Months 0 and 6	1860.9	1641.1 – 2110.2
Girls and Boys 9 to 14 Years V503 at Months 0 and 12	2810.4	2474.9 – 3191.3
Girls 9 to 14 Years V503 at Months 0, 2, and 6	2049.3	1806.4 – 2324.8
Young Women 16 to 26 Years V503 at Months 0, 2, and 6	761.5	670.8 – 864.5

Geometric Mean Titers to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen Primary · 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).

Group	Value	95% CI
Girls 9 to 14 Years V503 at Months 0 and 6	1436.3	1272.1 – 1621.8
Boys 9 to 14 Years V503 at Months 0 and 6	1498.2	1326.5 – 1692.0
Girls and Boys 9 to 14 Years V503 at Months 0 and 12	2117.5	1873.7 – 2393.1
Girls 9 to 14 Years V503 at Months 0, 2, and 6	1748.3	1548.1 – 1974.5
Young Women 16 to 26 Years V503 at Months 0, 2, and 6	572.1	505.8 – 647.2

Geometric Mean Titers to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen Primary · 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).

Group	Value	95% CI
Girls 9 to 14 Years V503 at Months 0 and 6	1030.0	920.4 – 1152.7
Boys 9 to 14 Years V503 at Months 0 and 6	1040.0	928.9 – 1164.3
Girls and Boys 9 to 14 Years V503 at Months 0 and 12	2197.5	1961.9 – 2461.3
Girls 9 to 14 Years V503 at Months 0, 2, and 6	796.4	712.0 – 890.9
Young Women 16 to 26 Years V503 at Months 0, 2, and 6	348.1	311.5 – 389.1

Geometric Mean Titers to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen Primary · 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).

Group	Value	95% CI
Girls 9 to 14 Years V503 at Months 0 and 6	357.6	313.7 – 407.6
Boys 9 to 14 Years V503 at Months 0 and 6	352.3	309.0 – 401.7
Girls and Boys 9 to 14 Years V503 at Months 0 and 12	417.7	365.9 – 476.9
Girls 9 to 14 Years V503 at Months 0, 2, and 6	661.7	580.6 – 754.1
Young Women 16 to 26 Years V503 at Months 0, 2, and 6	213.6	187.7 – 243.2

Geometric Mean Titers to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen Primary · 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).

Group	Value	95% CI
Girls 9 to 14 Years V503 at Months 0 and 6	581.1	521.9 – 647.1
Boys 9 to 14 Years V503 at Months 0 and 6	640.4	575.2 – 713.0
Girls and Boys 9 to 14 Years V503 at Months 0 and 12	1123.4	1008.1 – 1251.9
Girls 9 to 14 Years V503 at Months 0, 2, and 6	909.9	817.6 – 1012.5
Young Women 16 to 26 Years V503 at Months 0, 2, and 6	364.2	327.0 – 405.6

Geometric Mean Titers to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen Primary · 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).

Group	Value	95% CI
Girls 9 to 14 Years V503 at Months 0 and 6	1251.2	1119.6 – 1398.4
Boys 9 to 14 Years V503 at Months 0 and 6	1325.7	1186.2 – 1481.6
Girls and Boys 9 to 14 Years V503 at Months 0 and 12	2444.6	2185.2 – 2734.9
Girls 9 to 14 Years V503 at Months 0, 2, and 6	1229.3	1100.7 – 1373.0
Young Women 16 to 26 Years V503 at Months 0, 2, and 6	491.1	438.6 – 549.8

Percentage of Participants With Seroconversion to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen Secondary · 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.

Group	Value	95% CI
Girls 9 to 14 Years V503 at Months 0 and 6	100	98.6 – 100
Boys 9 to 14 Years V503 at Months 0 and 6	100	98.6 – 100
Girls and Boys 9 to 14 Years V503 at Months 0 and 12	100	98.6 – 100
Girls 9 to 14 Years V503 at Months 0, 2, and 6	99.6	97.8 – 100
Young Women 16 to 26 Years V503 at Months 0, 2, and 6	99.6	97.7 – 100

Percentage of Participants With Seroconversion to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen Secondary · 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.

Group	Value	95% CI
Girls 9 to 14 Years V503 at Months 0 and 6	100	98.7 – 100
Boys 9 to 14 Years V503 at Months 0 and 6	100	98.7 – 100
Girls and Boys 9 to 14 Years V503 at Months 0 and 12	100	98.6 – 100
Girls 9 to 14 Years V503 at Months 0, 2, and 6	100	98.6 – 100
Young Women 16 to 26 Years V503 at Months 0, 2, and 6	99.6	97.8 – 100

Adverse events — posted to ClinicalTrials.gov

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. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Girls 9 to 14 Years V503 at Months 0 and 6

Serious: 6/294 (2%)

Deaths: 0/294

Boys 9 to 14 Years V503 at Months 0 and 6

Serious: 9/296 (3%)

Deaths: 0/296

Girls and Boys 9 to 14 Years V503 at Months 0 and 12

Serious: 6/293 (2%)

Deaths: 0/293

Girls 9 to 14 Years V503 at Months 0, 2, and 6

Serious: 6/300 (2%)

Deaths: 1/300

Young Women 16 to 26 Years V503 at Months 0, 2, and 6

Serious: 11/313 (4%)

Deaths: 0/313

Serious adverse events (32 terms)

Reaction	System	Girls 9 to 14 Years V503 a…	Boys 9 to 14 Years V503 at…	Girls and Boys 9 to 14 Yea…	Girls 9 to 14 Years V503 a…	Young Women 16 to 26 Years…
Abortion induced	Surgical and medical procedures	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Cholecystitis acute	Hepatobiliary disorders	—	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—	—
Dengue fever	Infections and infestations	—	—	—	—	—
Gastroenteritis rotavirus	Infections and infestations	—	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—	—
Pharyngotonsillitis	Infections and infestations	—	—	—	—	—
Subcutaneous abscess	Infections and infestations	—	—	—	—	—
Animal bite	Injury, poisoning and procedural complications	—	—	—	—	—
Concussion	Injury, poisoning and procedural complications	—	—	—	—	—
Forearm fracture	Injury, poisoning and procedural complications	—	—	—	—	—
Epilepsy	Nervous system disorders	—	—	—	—	—
Premature delivery	Pregnancy, puerperium and perinatal conditions	—	—	—	—	—
Depression	Psychiatric disorders	—	—	—	—	—
Ovarian cyst	Reproductive system and breast disorders	—	—	—	—	—
Dermatitis atopic	Skin and subcutaneous tissue disorders	—	—	—	—	—
Venous thrombosis limb	Vascular disorders	—	—	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—	—	—
Chikungunya virus infection	Infections and infestations	—	—	—	—	—
Meningitis bacterial	Infections and infestations	—	—	—	—	—
Oral herpes	Infections and infestations	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—
Foreign body	Injury, poisoning and procedural complications	—	—	—	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Girls 9 to 14 Years V503 a…	Boys 9 to 14 Years V503 at…	Girls and Boys 9 to 14 Yea…	Girls 9 to 14 Years V503 a…	Young Women 16 to 26 Years…
Injection site pain	General disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—

Most-reported serious reactions: Abortion induced, Abdominal pain, Diarrhoea, Cholecystitis acute, Appendicitis, Dengue fever, Gastroenteritis rotavirus, Pharyngitis.

Data from ClinicalTrials.gov NCT01984697 adverse events section.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Virus-like particle vaccinology, from bench to bedside.
Mohsen MO, Bachmann MF. · · 2022 · cited 181× · PMID 35962190 · DOI 10.1038/s41423-022-00897-8
Immunogenicity of the 9-Valent HPV Vaccine Using 2-Dose Regimens in Girls and Boys vs a 3-Dose Regimen in Women.
Iversen OE, Miranda MJ, Ulied A, Soerdal T, et al · · 2016 · cited 144× · PMID 27893068 · DOI 10.1001/jama.2016.17615
Virus-like particle vaccines: immunology and formulation for clinical translation.
Donaldson B, Lateef Z, Walker GF, Young SL, et al · · 2018 · cited 108× · PMID 30173619 · DOI 10.1080/14760584.2018.1516552
Comparison of different human papillomavirus (HPV) vaccine types and dose schedules for prevention of HPV-related disease in females and males.
Bergman H, Buckley BS, Villanueva G, Petkovic J, et al · · 2019 · cited 90× · PMID 31755549 · DOI 10.1002/14651858.cd013479
Human papillomavirus 9-valent vaccine for cancer prevention: a systematic review of the available evidence.
Signorelli C, Odone A, Ciorba V, Cella P, et al · · 2017 · cited 44× · PMID 28446260 · DOI 10.1017/s0950268817000747
Plant Viruses and Bacteriophage-Based Reagents for Diagnosis and Therapy.
Shukla S, Hu H, Cai H, Chan SK, et al · · 2020 · cited 27× · PMID 32991265 · DOI 10.1146/annurev-virology-010720-052252
Targeting lymph node delivery with nanovaccines for cancer immunotherapy: recent advances and future directions.
Li Y, Li S, Jiang Z, Tan K, et al · · 2023 · cited 21× · PMID 37415161 · DOI 10.1186/s12951-023-01977-1
Three-Year Follow-up of 2-Dose Versus 3-Dose HPV Vaccine.
Bornstein J, Roux S, Kjeld Petersen L, Huang LM, et al · · 2021 · cited 16× · PMID 33386332 · DOI 10.1542/peds.2019-4035

Verify or expand the search:

Other recruiting trials for Human Papillomavirus Infection

Currently open trials in the same condition.

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Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01984697 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 8 August 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01984697.

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