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A Phase II Trial Evaluate the Immunogenicity and Safety Profile of HPV Vaccine

NCT05694728 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 780

Last updated 2023-01-23

No results posted yet for this study

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.

Conditions

  • Human Papilloma Virus Infection

Interventions

BIOLOGICAL

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

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.

BIOLOGICAL

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

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

Sponsors & Collaborators

  • Jiangsu Province Centers for Disease Control and Prevention

    collaborator NETWORK

  • National Institutes for Food and Drug Control, China

    collaborator OTHER

  • Nanjing Sangruisi pharmtech Ltd.

    collaborator UNKNOWN

  • Shanghai Canming pharmtech Ltd.

    collaborator UNKNOWN

  • Beijing Health Guard Biotechnology, Inc

    lead INDUSTRY

Principal Investigators

  • Yongjiang Liu, Bachelor · Beijing Health Guard Biotechnology, Inc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-23
Primary Completion
2020-12-11
Completion
2021-01-27

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05694728 on ClinicalTrials.gov