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Safety and Immunogenicity Study of Human Papilloma Virus Vaccine in Women Aged 9 to 30 and Men Aged 9 to 17

NCT02888418 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2016-09-05

No results posted yet for this study

Summary

This study evaluates the safety of Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha) in women of 9 to 30 years old and men of 9 to 17 years old and preliminarily explore the immunogenicity.

135 people are enrolled in total, including 45 women of 18 to 30 years old and 90 people of 9 to 17 years old. Among the first group, 30 women will be inoculated studied vaccine and 15 women will be inoculated placebo. Among the second group, there are 45 women and 45 men, 30 women and 30 men in vaccine group and 15 women and 15 men in placebo group.

Conditions

Interventions

BIOLOGICAL

Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha)

Injection vaccine produced by Beijing institute of biological products co., LTD, containing HPV antigen protein, 120μg/0.5ml/bottle

BIOLOGICAL

placebo

Sponsors & Collaborators

  • Beijing Chaoyang District Centre for Disease Control and Prevention

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
9 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-10-31
Completion
2017-12-31

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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 NCT02888418 on ClinicalTrials.gov