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Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls

NCT03206255 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 940

Last updated 2019-01-04

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the immuno-persistence (type specific IgG antibody) of the tested vaccine administered in girls aged 9-17 years ,comparing to young healthy adults of 18-26 years who received the standard 3-dose schedule (0,1,6 months).

Conditions

  • Cervical Intraepithelial Neoplasia
  • Cervical Cancer
  • Vaginal Intraepithelial Neoplasia
  • Vulvar Intraepithelial Neoplasia
  • Persistent Infection

Interventions

PROCEDURE

3 doses of HPV 16/18 bivalent vaccine

Participants have received 60μg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months)

PROCEDURE

2 doses of HPV 16/18 bivalent vaccine

Participants have received 60μg of HPV 16/18 bivalent vaccine according to an alternative 2-dose schedule (0,6 months)

Sponsors & Collaborators

  • Xiamen Innovax Biotech Co., Ltd

    collaborator INDUSTRY

  • Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

    collaborator INDUSTRY

  • Jun Zhang

    lead OTHER

Principal Investigators

  • Ting Wu, Ph. D. · Xiamen University

  • Yuemei Hu, Bachelor · Jiangsu Provincial Centre for Disease Control and Prevention

Eligibility

Min Age
10 Years
Max Age
28 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2018-08-15
Completion
2018-08-15

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT03206255 on ClinicalTrials.gov