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A Phase III Study of Human Papillomavirus (HPV)-16/18 Vaccine.

NCT02733068 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12000

Last updated 2022-12-19

No results posted yet for this study

Summary

A Phase III Double Blinded, Randomized Controlled Study to Evaluate Efficacy of Protection Against HPV-16 and 18 Related Diseases, Immunogenicity and Safety of Recombinant Human Papillomavirus Virus-like Particle Vaccine (Type 16 and 18 L1 Proteins, Yeast) in Healthy Females Aged 18-30 Years.

Conditions

  • Human Papilloma Virus Infection Type 16
  • Human Papilloma Virus Infection Type 18
  • Cervical Intraepithelial Neoplasia

Interventions

BIOLOGICAL

HPV-16/18 vaccine

0.5ml of recombinant human papillomavirus virus-like particle vaccine (Type 16 and 18 L1 Proteins, Yeast) on upper arm deltoid muscle with a three-dose-schedule (0, 2, 6 months).

BIOLOGICAL

HPV-16/18 placebo

0.5ml of placebo on upper arm deltoid muscle with a three-dose-schedule (0, 2, 6 months).

Sponsors & Collaborators

  • Guangxi Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Shanghai Zerun Biotechnology Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Zhaojun Mo · Guangxi Center for Disease Prevention and Control(GXCDC)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-02
Primary Completion
2019-07-30
Completion
2020-01-16

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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 NCT02733068 on ClinicalTrials.gov