CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 780 enrolled
Drug / intervention
Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05694728
NCT05694728Phase 2Completed
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A Phase II Trial in Healthy Chinese Women Ages 20-45 to Evaluate the Immunogenicity and Safety Profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli)

Beijing Health Guard Biotechnology, Inc·interventional·Posted Jan 23, 2023·Updated Jan 23, 2023

In Brief

A Phase 2 clinical trial evaluating Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) and Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae) for Human Papilloma Virus Infection. Completed, enrolled 780 participants across 1 site.

Detailed Summary

This trail is to evaluate the safety profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) in healthy Chinese women ages 20-45 and determine the optimal ratio of the antigens included in the investigational vaccine. Besides, the trail is also to demonstrate that the levels of neutralizing antibodies to vaccine HPV types 31, 33, 45, 52 and 58 elicited by the investigational vaccine with the chosen optimal antigen ratio are superior to those induced by Gardasil.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Papilloma Virus Infection
CountriesChina
CollaboratorsJiangsu Province Centers for Disease Control and Prevention, National Institutes for Food and Drug Control, China, Nanjing Sangruisi pharmtech Ltd., Shanghai Canming pharmtech Ltd.

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJan 23, 2023
Enrollment StartMay 23, 2020
Primary CompletionDec 11, 2020
Study CompletionJan 27, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 3.4 years ago

Interventions

Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli)biological

For Mid-dosage group, a 3-dose regimen administered at months 0, 2 and 6. For High-dosage group, a 3-dose regimen administered at months 0, 2 and 6.

Recombinant Quadrivalent Human Papillomavirus (Types 6,11,16,18) Vaccine (Saccharomyces cerevisiae)biological

A 3-dose regimen administered at months 0, 2 and 6.