MedTrace Logo

A Phase I Trial Evaluate the Safety and Tolerability Profile of HPV Vaccine

NCT05680454 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2023-01-17

No results posted yet for this study

Summary

This study is to evaluate the safety and tolerability profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) in healthy women ages 18-45

Conditions

  • Human Papillomavirus Infection

Interventions

BIOLOGICAL

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

For Low-dosage group, a 3-dose regimen administered at months 0, 2 and 6. 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 nonavalent Human Papillomavirus (Types 6,11,16,18,31,33,45,52,58) Vaccine

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 Pharmaceutical Technology Co., Ltd

    collaborator UNKNOWN

  • School of Public Health of Southeastern University

    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
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2020-04-06
Completion
2022-05-10

Countries

  • China

Study Locations

More Related Trials

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 NCT05680454 on ClinicalTrials.gov