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Evaluate the Safety of Recombinant Human Papillomavirus Bivalent (Types 16 and 18) Vaccine (Yeast) in Healthy Females

NCT01548118 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2012-03-08

No results posted yet for this study

Summary

This study will evaluate the safety of a novel recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( Yeast ) with different dose in healthy females between 9-45 years of age at enrollment.

Conditions

  • Human Papillomavirus

Interventions

BIOLOGICAL

HPV 16/18 vaccine, 0,5ml

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

BIOLOGICAL

Placebo control, 0.5ml

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

BIOLOGICAL

HPV 16/18 vaccine, 1.0ml

Subjects were planned to receive HPV vaccine 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule

BIOLOGICAL

Placebo control, 1.0ml

Subjects were planned to receive three doses of the placebo control 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule.

Sponsors & Collaborators

  • Shanghai Zerun Biotechnology Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Yan-ping Li, MD · Guangxi Centers for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-10-31
Completion
2012-12-31

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 NCT01548118 on ClinicalTrials.gov