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

NCT02710851 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2023-06-15

No results posted yet for this study

Summary

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

Conditions

  • Condylomata Acuminata

Interventions

BIOLOGICAL

low dosage HPV Vaccine(1:1)

Participants would intramuscularly receive low dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:1 ratio. All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month.

BIOLOGICAL

low dosage HPV Vaccine(1:2)

Participants would intramuscularly receive low dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:2 ratio. All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month.

BIOLOGICAL

high dosage HPV Vaccine(1:1)

Participants would intramuscularly receive high dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:1 ratio. All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month.

BIOLOGICAL

Hepatitis E vaccine,Hecolin®

Participants would intramuscularly receive Hepatitis E vaccine for 3 doses at 0, 1, 6 month.

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

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

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
2016-03-24
Primary Completion
2023-12-30
Completion
2023-12-30

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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 NCT02710851 on ClinicalTrials.gov