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A Study of Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine

NCT03900572 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-04-13

No results posted yet for this study

Summary

A randomized, double-blind and placebo-controlled phase I study to evaluate the safety and immunogenicity of a 9-valent Human Papillomavirus (HPV) vaccine, administered intramuscularly according to a 0, 2, 6-month schedule in 9 to 45 years old healthy Chinese females.

Conditions

  • HPV Infections

Interventions

BIOLOGICAL

HPV Vaccine

Intramuscular injection, 3 doses

DRUG

Placebo

Intramuscular injection, 3 doses

Sponsors & Collaborators

  • Shanghai Zerun Biotechnology Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Xuecheng LIU, BS · Sichuan Provincial Center for Disease Prevention and Control

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-03-09
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT03900572 on ClinicalTrials.gov