Who is sponsoring NCT03493542?

NCT03493542 is sponsored by Merck Sharp & Dohme LLC.

What drugs are being tested in NCT03493542?

Interventions in NCT03493542: V501.

Is NCT03493542 still recruiting?

NCT03493542 is currently completed. Last updated 31 December 2024.

Are results published for NCT03493542?

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

Last reviewed 2024-12-31 · How we verify

NCT03493542

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

A Study to Evaluate the Immunogenicity, Safety and Tolerability of Quadrivalent Human Papillomavirus Vaccine (V501) in Chinese Girls Aged 9-19 Years and Young Women Aged 20-26 Years (V501-213)

Completed Phase 3 Results posted Last updated 31 December 2024

What this trial tests

Phase 3 trial testing V501 in Prevention of HPV Types 16- and 18-related Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN) 1/2/3, and Cervical Adenocarcinoma in Situ in 766 participants. Completed in 30 October 2023.

Timeline

31 August 2018

Primary endpoint
30 October 2023

30 October 2023

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	766
Start date	31 August 2018
Primary completion	30 October 2023
Estimated completion	30 October 2023
Sites	1 location across China

Drugs / interventions tested

V501 — full drug profile →

Conditions studied

Prevention of HPV Types 16- and 18-related Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN) 1/2/3, and Cervical Adenocarcinoma in Situ — all drugs for Prevention of HPV Types 16- and 18-related Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN) 1/2/3, and Cervical Adenocarcinoma in Situ →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 9 to 26, female only, with Prevention of HPV Types 16- and 18-related Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN) 1/2/3, and Cervical Adenocarcinoma in Situ. 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.

Base Stage: Geometric Mean Titers for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18: Competitive Luminex Immunoassay (cLIA) Primary · Month 7 (1 month postdose 3)

Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL).

Anti-HPV 6

Group	Value	95% CI
Chinese Girls Aged 9 to 19 Years	975.2	905.6 – 1050.2
Base Study: Chinese Young Women Aged 20 to 26 Years	686.6	635.5 – 741.7

Anti-HPV 11

Group	Value	95% CI
Chinese Girls Aged 9 to 19 Years	807.4	749.8 – 869.4
Base Study: Chinese Young Women Aged 20 to 26 Years	580.2	537.0 – 626.8

Anti-HPV 16

Group	Value	95% CI
Chinese Girls Aged 9 to 19 Years	4573.7	4244.5 – 4928.3
Base Study: Chinese Young Women Aged 20 to 26 Years	2989.2	2766.7 – 3229.6

Anti-HPV 18

Group	Value	95% CI
Chinese Girls Aged 9 to 19 Years	1176.5	1069.0 – 1294.8
Base Study: Chinese Young Women Aged 20 to 26 Years	708.6	642.4 – 781.6

Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA Primary · Month 12 post-vaccination 1

Anti-HPV 6

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	259.1	237.6 – 282.4

Anti-HPV 11

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	206.7	190.5 – 224.3

Anti-HPV 16

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	1149.8	1054.6 – 1253.7

Anti-HPV 18

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	284.2	257.3 – 313.8

Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA Primary · Month 24 post-vaccination 1

Anti-HPV 6

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	137.9	125.5 – 151.4

Anti-HPV 11

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	110.3	101.0 – 120.6

Anti-HPV 16

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	522.6	472.1 – 578.5

Anti-HPV 18

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	157.2	142.7 – 173.3

Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA Primary · Month 36 post-vaccination 1

Anti-HPV 6

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	110.6	101.3 – 120.7

Anti-HPV 11

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	87.0	79.6 – 95.2

Anti-HPV 16

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	400.8	359.5 – 446.8

Anti-HPV 18

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	131.9	120.2 – 144.8

Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA Primary · Month 48 post-vaccination 1

Anti-HPV 6

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	103.0	94.4 – 112.4

Anti-HPV 11

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	81.8	74.8 – 89.3

Anti-HPV 16

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	347.5	310.0 – 389.6

Anti-HPV 18

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	130.3	118.9 – 142.7

Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA Primary · Month 60 post-vaccination 1

Serum antibody titers (Geometric mean titers) for HPV virus-like particles (VLPs) Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL).

Anti-HPV 6

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	87.6	80.4 – 95.4

Anti-HPV 11

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	67.3	61.6 – 73.5

Anti-HPV 16

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	283.2	250.8 – 319.8

Anti-HPV 18

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	113.6	103.7 – 124.5

Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA Primary · Month 12 post-vaccination 1

The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.

Anti-HPV 6

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Year	99.1	97.4 – 99.8

Anti-HPV 11

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Year	99.7	98.3 – 100.0

Anti-HPV 16

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Year	100.0	98.9 – 100.0

Anti-HPV 18

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Year	96.9	94.3 – 98.5

Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA Primary · Month 24 post-vaccination 1

The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.

Anti-HPV 6

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Year	88.8	84.9 – 92.0

Anti-HPV 11

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Year	95.3	92.4 – 97.4

Anti-HPV 16

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Year	99.7	98.3 – 100.0

Anti-HPV 18

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Year	87.7	83.5 – 91.1

Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA Primary · Month 36 post-vaccination 1

The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.

Anti-HPV 6

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Year	83.6	79.1 – 87.5

Anti-HPV 11

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Year	92.1	88.6 – 94.8

Anti-HPV 16

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Year	98.8	96.9 – 99.7

Anti-HPV 18

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Year	84.0	79.4 – 87.9

Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA Primary · Month 48 post-vaccination 1

The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.

Anti-HPV 6

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Year	68.5	63.0 – 73.6

Anti-HPV 11

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Year	85.2	80.8 – 89.0

Anti-HPV 16

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Year	91.9	88.4 – 94.6

Anti-HPV 18

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Year	64.6	58.9 – 70.0

Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA Primary · Month 60 post-vaccination 1

The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA.

Anti-HPV 6

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Year	61.9	56.2 – 67.3

Anti-HPV 11

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Year	74.9	69.7 – 79.7

Anti-HPV 16

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Year	87.1	82.9 – 90.6

Anti-HPV 18

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Year	58.3	52.5 – 63.9

Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 12 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) Primary · Month 12 post-vaccination 1

Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL).

Anti-HPV 6

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	217.0	198.1 – 237.6

Anti-HPV 11

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	172.1	158.3 – 187.1

Anti-HPV 16

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	1025.8	945.5 – 1113.0

Anti-HPV 18

Group	Value	95% CI
Extension Study: Chinese Girls Aged 9 to 19 Years	228.0	204.4 – 254.4

Adverse events — posted to ClinicalTrials.gov

Time frame: Base Stage only: Up to approximately 7 months Extension Stage: Month 7 up to approximately 60 Months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Base Study: Chinese Girls Aged 9 to 19 Years

Serious: 6/383 (2%)

Deaths: 0/383

Base Study: Chinese Young Women Aged 20 to 26 Years

Serious: 11/383 (3%)

Deaths: 0/383

Extension Study: Chinese Girls Aged 9 to 19 Years

Serious: 8/365 (2%)

Deaths: 0/365

Serious adverse events (42 terms)

Reaction	System	Base Study: Chinese Girls …	Base Study: Chinese Young …	Extension Study: Chinese G…
Hyperemesis gravidarum	Pregnancy, puerperium and perinatal conditions	—	—	—
Chronic gastritis	Gastrointestinal disorders	—	—	—
Gastrointestinal disorder	Gastrointestinal disorders	—	—	—
Haemorrhoids	Gastrointestinal disorders	—	—	—
Hypertrophic anal papilla	Gastrointestinal disorders	—	—	—
Bacterial vulvovaginitis	Infections and infestations	—	—	—
Complicated appendicitis	Infections and infestations	—	—	—
Helicobacter infection	Infections and infestations	—	—	—
Pelvic abscess	Infections and infestations	—	—	—
Skin infection	Infections and infestations	—	—	—
Vulvovaginal candidiasis	Infections and infestations	—	—	—
Ankle fracture	Injury, poisoning and procedural complications	—	—	—
Concussion	Injury, poisoning and procedural complications	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—
Foot fracture	Injury, poisoning and procedural complications	—	—	—
Ligament sprain	Injury, poisoning and procedural complications	—	—	—
Pelvic fracture	Injury, poisoning and procedural complications	—	—	—
Peroneal nerve injury	Injury, poisoning and procedural complications	—	—	—
Post procedural haemorrhage	Injury, poisoning and procedural complications	—	—	—
Rib fracture	Injury, poisoning and procedural complications	—	—	—
Sciatic nerve injury	Injury, poisoning and procedural complications	—	—	—
Skull fractured base	Injury, poisoning and procedural complications	—	—	—
Spinal fracture	Injury, poisoning and procedural complications	—	—	—
Tibia fracture	Injury, poisoning and procedural complications	—	—	—
Ulna fracture	Injury, poisoning and procedural complications	—	—	—

Other adverse events (9 terms — click to expand)

Reaction	System	Base Study: Chinese Girls …	Base Study: Chinese Young …	Extension Study: Chinese G…
Injection site pain	General disorders	—	—	—
Pyrexia	General disorders	—	—	—
Fatigue	General disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Injection site pruritus	General disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—
Injection site swelling	General disorders	—	—	—

Most-reported serious reactions: Hyperemesis gravidarum, Chronic gastritis, Gastrointestinal disorder, Haemorrhoids, Hypertrophic anal papilla, Bacterial vulvovaginitis, Complicated appendicitis, Helicobacter infection.

Data from ClinicalTrials.gov NCT03493542 adverse events section.

Sponsor's own description

This study is designed to evaluate the immunogenicity, safety, and tolerability of Gardasil® (quadrivalent human papillomavirus \[qHPV\] vaccine, V501) in Chinese girls aged 9-19 years and young women aged 20-26 years. The primary hypothesis of the study states that at 1 month postdose 3, a 3-dose regimen of V501 induces non-inferior geometric mean titers (GMTs) for serum anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18 in girls aged 9-19 years compared to young women aged 20-26 years.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Immunogenicity and safety of the quadrivalent human papillomavirus vaccine in Chinese females aged 9 to 26 years: A phase 3, open-label, immunobridging study.
Huang Z, He J, Su J, Ou Z, et al · · 2021 · cited 3× · PMID 33239228 · DOI 10.1016/j.vaccine.2020.11.008

Verify or expand the search:

Other trials of V501

Trials testing the same drug.

NCT02576054 — Safety and Tolerability Study of V501 in Japanese Boys (V501-200) · Phase 3 · completed
NCT01862874 — Efficacy and Tolerability Study of V501 in Japanese Males (V501-122) · Phase 3 · completed
NCT01544478 — V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110) · Phase 4 · completed
NCT00092547 — A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018) · Phase 3 · completed

Other Merck Sharp & Dohme LLC trials

Trials by the same sponsor.

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NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527 · Phase 1 · not yet recruiting
NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M · Phase 3 · not yet recruiting
NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti · Phase 1 · not yet recruiting

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 NCT03493542 (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: 31 December 2024

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/NCT03493542.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03493542

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (42 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of V501

Other Merck Sharp & Dohme LLC trials

Verify against primary sources