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NCT05668572
A Phase III Trial Evaluates the Efficacy, Immunogenicity and Safety Profile of HPV Vaccine
Phase 3 trial testing Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli) in Human Papillomavirus Infection in 12,000 participants. Status unknown.
21 July 2022
Quick facts
| Lead sponsor | Beijing Health Guard Biotechnology, Inc |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 12,000 |
| Start date | 5 December 2020 |
| Primary completion | 21 July 2022 |
| Estimated completion | 23 February 2023 |
| Sites | 3 locations across China |
Drugs / interventions tested
- Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli)
- Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)（GARDASIL®）
Conditions studied
- Human Papillomavirus Infection — all drugs for Human Papillomavirus Infection →
Sponsor
Beijing Health Guard Biotechnology, Inc — full company profile →
Who can join
Adults 20 to 45, female only, with Human Papillomavirus Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is to demonstrate that the administration of the investigational vaccine can reduce the Combined Incidence of HPV types 6/11/16/18/31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), high-grade Anal Intraepithelial Neoplasia (AIN 2/3), vulvar cancer, vaginal cancer or anal cancer.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Opportunities and challenges for human papillomavirus vaccination in China.
Zhao C, Zhao Y, Li J, Li M, et al · · 2024 · cited 30× · PMID 38575524 · DOI 10.1080/21645515.2024.2329450 -
HPV pathogenesis, various types of vaccines, safety concern, prophylactic and therapeutic applications to control cervical cancer, and future perspective.
Ashique S, Hussain A, Fatima N, Altamimi MA. · · 2023 · cited 14× · PMID 37363362 · DOI 10.1007/s13337-023-00824-z -
Prokaryote- and Eukaryote-Based Expression Systems: Advances in Post-Pandemic Viral Antigen Production for Vaccines.
Khudainazarova NS, Granovskiy DL, Kondakova OA, Ryabchevskaya EM, et al · · 2024 · cited 4× · PMID 39596049 · DOI 10.3390/ijms252211979 -
New HPV Vaccines on the Market and Future Trends: A State-of-the-Art Review.
Akgör U, Temiz BE, Cengiz M, Ege HV, et al · · 2026 · cited 1× · PMID 41746062 · DOI 10.3390/vaccines14020140
Verify or expand the search:
- PubMed search for NCT05668572
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli)
Trials testing the same drug.
- NCT05662020 — A Study to Evaluate the Immunogenicity and Safety of HPV Vaccine in Healthy Female Participants Aged 9-26 Years in China · Phase 3 · active not recruiting
Other recruiting trials for Human Papillomavirus Infection
Currently open trials in the same condition.
- NCT07281430 — Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S04) · NA · recruiting
- NCT06598475 — Investigating Facilitator-driven, Multi-level Implementation Strategies in Federally Qualified Health Centers to Improve · NA · recruiting
- NCT06611553 — Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S02) · NA · active not recruiting
- NCT06611540 — Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S03) · NA · active not recruiting
- NCT06498661 — Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S01) · NA · recruiting
Other Beijing Health Guard Biotechnology, Inc trials
Trials by the same sponsor.
- NCT06207175 — A Study to Evaluate the Immunogenicity and Safety of Nonavalent Human Papillomavirus (HPV) Vaccine · Phase 3 · unknown
- NCT05662020 — A Study to Evaluate the Immunogenicity and Safety of HPV Vaccine in Healthy Female Participants Aged 9-26 Years in China · Phase 3 · active not recruiting
- NCT05694728 — A Phase II Trial Evaluate the Immunogenicity and Safety Profile of HPV Vaccine · Phase 2 · completed
- NCT05680454 — A Phase I Trial Evaluate the Safety and Tolerability Profile of HPV Vaccine · 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)
- Trial protocol + status: ClinicalTrials.gov NCT05668572 (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 Beijing Health Guard Biotechnology, Inc
- Last refreshed: 4 January 2023
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/NCT05668572.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing