MedTrace Logo

Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

NCT03676101 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-01-22

No results posted yet for this study

Summary

To evaluate the safety and immunogenicity of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 9-45 Years.

Conditions

  • Cervical Cancers
  • Vulvar Cancer
  • Vaginal Cancer
  • CIN1
  • CIN2
  • CIN 3
  • AIS
  • Invasive Carcinoma
  • Mild Dysplasia of Vulva
  • Moderate Dysplasia of Vulva
  • Vin III
  • VaIN1
  • VaIN2
  • VaIN3
  • Genital Wart

Interventions

BIOLOGICAL

9-valent HPV Recombinant Vaccine

Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.

BIOLOGICAL

Placebo

Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule.

Sponsors & Collaborators

  • Chongqing Bovax Biopharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Shanghai Bovax Biotechnology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-10-10
Primary Completion
2019-08-20
Completion
2020-01-10

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03676101 on ClinicalTrials.gov