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Evaluating the 2-dose Immunization Schedule of Human Papillomavirus (HPV)-16/18 in Adolescent Females

NCT02740777 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2023-04-13

No results posted yet for this study

Summary

To evaluate the immune non-inferiority, as measured by antibody responses, of a 2-dose immunization schedule (0, 6 months) of recombinant human papillomavirus virus-like particle vaccine (type 16 and 18 L1 proteins, yeast) (hereinafter referred as HPV-2 vaccine) in adolescent females aged 9 to 14 years in comparison to 3-dose immunization schedule (0, 2, 6 months) in young females aged 18 to 26 years.

Conditions

  • Human Papillomavirus
  • Cervical Intraepithelial Neoplasia
  • Persistent Infection

Interventions

BIOLOGICAL

HPV-16/18 vaccine

HPV 16 L1 virus like particles (VLP) 40μg; HPV 18 L1 VLP 20μg; Aluminium phosphate 225μg; NaCl 0.32M; Histidine buffer 10mM; Tween-80 0.01%.

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
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-11-30
Completion
2019-07-31

Countries

  • China

Study Locations

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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 NCT02740777 on ClinicalTrials.gov