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Safety and Immunogenicity Study of the Recombinant Human Papillomavirus Virus Type 6/11 Bivalent Vaccine

NCT02405520 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2022-05-24

No results posted yet for this study

Summary

This phase I clinical study was designed to evaluate the safety and immunogenicity of the novel recombinant HPV type 6/11 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged over 18-55 years of age at enrollment. The study volunteers will receive the 3 different formulations of the novel HPV vaccine or placebo administered intramuscularly according to a 0-1-6 month schedule.

Conditions

  • Condylomata Acuminata

Interventions

BIOLOGICAL

low dosage HPV Vaccine

Participants would intramuscularly receive low dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses.

BIOLOGICAL

medium dosage HPV Vaccine

Participants would intramuscularly receive medium dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses.

BIOLOGICAL

high dosage HPV Vaccine

Participants would intramuscularly receive high dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses.

BIOLOGICAL

Aluminium Adjuvant

Participants would intramuscularly receive aluminium adjuvant at 0, 1, 6 month for 3 doses.

Sponsors & Collaborators

  • Xiamen Innovax Biotech Co., Ltd

    collaborator INDUSTRY

  • Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

    collaborator INDUSTRY

  • Jun Zhang

    lead OTHER

Principal Investigators

  • Jun Zhang, Master · Xiamen University

  • Zhao-Jun Mo, Master · Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control

  • Ting Wu, Ph. D · Xiamen University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-26
Primary Completion
2019-06-05
Completion
2022-05-20

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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 NCT02405520 on ClinicalTrials.gov