NCT03676101 is a Phase 1 clinical trial of 9-valent HPV Recombinant Vaccine in Cervical Cancers, sponsored by Shanghai Bovax Biotechnology Co., Ltd..

Who is sponsoring NCT03676101?

NCT03676101 is sponsored by Shanghai Bovax Biotechnology Co., Ltd..

What drugs are being tested in NCT03676101?

Interventions in NCT03676101: 9-valent HPV Recombinant Vaccine, Placebo.

What condition does NCT03676101 study?

NCT03676101 studies Cervical Cancers, Vulvar Cancer, Vaginal Cancer, CIN1, CIN2, CIN 3, AIS, Invasive Carcinoma, Mild Dysplasia of Vulva, Moderate Dysplasia of Vulva, Vin III, VaIN1, VaIN2, VaIN3, Genital Wart.

Is NCT03676101 still recruiting?

NCT03676101 is currently completed. Last updated 22 January 2020.

Last reviewed 2020-01-22 · How we verify

NCT03676101

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

Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

Completed Phase 1 Last updated 22 January 2020

What this trial tests

Phase 1 trial testing 9-valent HPV Recombinant Vaccine in Cervical Cancers in 90 participants. Completed in 10 January 2020.

Timeline

10 October 2018

Primary endpoint
20 August 2019

10 January 2020

Quick facts

Lead sponsor	Shanghai Bovax Biotechnology Co., Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	90
Start date	10 October 2018
Primary completion	20 August 2019
Estimated completion	10 January 2020
Sites	1 location across China

Drugs / interventions tested

9-valent HPV Recombinant Vaccine — full drug profile →
Placebo

Conditions studied

Cervical Cancers — all drugs for Cervical Cancers →
Vulvar Cancer — all drugs for Vulvar Cancer →
Vaginal Cancer — all drugs for Vaginal Cancer →
CIN1 — all drugs for CIN1 →

Sponsor

Shanghai Bovax Biotechnology Co., Ltd. — full company profile →

Who can join

Adults 9 to 45, female only, with Cervical Cancers or Vulvar Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To evaluate the safety and immunogenicity of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 9-45 Years.

Publications & conference data

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

Exploring the Intricacies of Cervical Intraepithelial Neoplasia and Its Connection with HPV: A Narrative Review.
Karimi P, Reza Hosseini SM, Mousavian Hiagh ZS, Aboulhassanzadeh S, et al · · 2024 · cited 4× · PMID 39759206 · DOI 10.18502/ijph.v53i12.17310
The Non-inferiority of Human Papillomavirus Vaccine Immunogenicity Among Women Over 26 Years: A Systematic Review.
Andijani O, Alsalhi S. · · 2024 · cited 1× · PMID 39176354 · DOI 10.7759/cureus.65157

Verify or expand the search:

Other recruiting trials for Cervical Cancers

Currently open trials in the same condition.

NCT06910657 — IDOV-Immune for Advanced Solid Tumors · Phase 1 · recruiting
NCT07130240 — Ivonescimab Combined With Paclitaxel and Cisplatin as Neoadjuvant Therapy Followed by Type A Hysterectomy in Stage IB2 a · Phase 2 · recruiting
NCT07038369 — A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations · Phase 1 · active not recruiting
NCT06867445 — Minimally Invasive Pelvic Exenteration in Vaginal or Cervical Cancer Recurrence · NA · recruiting
NCT07003620 — Neoadjuvant Immunochemotherapy for Locally Advanced Cervical Cancer: a Prospective, Single-arm, Phase II Clinical Trial · Phase 2 · recruiting

Other Shanghai Bovax Biotechnology Co., Ltd. trials

Trials by the same sponsor.

NCT06756269 — To Evaluate the Safety and Immunogenicity of 15-valent HPV Recombinant Vaccine in Chinese People Aged 9-45 Years · Phase 2 · recruiting
NCT06454175 — A Phase I Clinical Trial to Evaluate the Safety of 15-valent HPV Vaccine in Healthy Chinese People Aged 18-45 Years · Phase 1 · active not recruiting
NCT06465914 — A Phase III Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent HPV Vaccine in Chinese Males · Phase 3 · active not recruiting
NCT05584332 — A Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity, Safety of Quadrivalent HPV Recombinant Vaccine in Chinese Heal · Phase 3 · terminated
NCT05518201 — Evaluate the Safety and Immunogenicity of a 9-valent HPV Vaccine in Chinese Healthy Male Aged 9-45 Year-old · Phase 1 · completed

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 NCT03676101 (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 Shanghai Bovax Biotechnology Co., Ltd.
Last refreshed: 22 January 2020

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/NCT03676101.

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