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Immunogenicity and Safety of Human Papillomavirus (HPV)-16/18 Vaccine in Healthy Females

NCT02740790 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2023-04-13

No results posted yet for this study

Summary

Evaluate immunogenicity and safety of recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( Yeast )in different age group. And evaluate persistence of immune response in 9-17years age group. To demonstrate that 9-17years age group was non-inferior to 18-26 years age group and 27-45 years age group in terms of immunogenicity.

Conditions

  • Human Papillomavirus

Interventions

BIOLOGICAL

HPV vaccine

Subjects were planned to receive HPV vaccine 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule

BIOLOGICAL

Placebo

Subjects were planned to receive three doses of the placebo control 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule

Sponsors & Collaborators

  • Shanghai Zerun Biotechnology Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Rong-cheng Li, MD · Guangxi Centers for Disease Control and Prevention

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
2013-09-30
Primary Completion
2015-09-30
Completion
2017-12-31

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 NCT02740790 on ClinicalTrials.gov