NCT02360514

Brief Summary

This study was aimed evaluate long-term immunity response by neutralizing antibody test of adults in high risk population of HFRS .

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2007

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
Last Updated

February 10, 2015

Status Verified

February 1, 2015

Enrollment Period

4.8 years

First QC Date

February 3, 2015

Last Update Submit

February 9, 2015

Conditions

Infection

Outcome Measures

Primary Outcomes (1)

  • Antibody seroconversion rates at 1 month after the booster vaccination and its retention rates

    13 months

Secondary Outcomes (4)

  • The antibody seroconversion rates and its retension rates by neutralizing antibody test

    13 months

  • The antibody seroconversion rates and its retension rates by fluorescent antibody technique

    13 months

  • The antibody titers by neutralizing antibody test and fluorescent antibody technique

    13 months

  • Number of adverse events after vaccination of Hantavax to adults in high risk population.

    3 years

Study Arms (1)

hantaan virus vaccine

EXPERIMENTAL
Drug: Hantavax injection

Interventions

Hantavax injectionDRUG

Intramuscular or hypodermic injection of 0.5ml per time twice at interval of 1 month for adults. For more immune, inoculate muscle or subcutaneous once mor 12 months after the completion of the initial immune

hantaan virus vaccine

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subjects who have the vaccination history of ah the time of screening
  • The subjects whose Hantaan virus virus's antibody shows negative using Neutralizing antibody test at the time of screening

You may not qualify if:

  • The subjects who have a history of hemorrhagic fever with renal syndrome
  • The subjects who have a fever or significant dystrophy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infections

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 10, 2015

Study Start

December 1, 2007

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

February 10, 2015

Record last verified: 2015-02