NCT00356798

Brief Summary

Based on pre-clinical trial data and principle of GCP, the objective of phase I clinical trial is to evaluate safety and immunogenicity of Pan-flu vaccine, an inactivated whole virion H5N1 vaccine with aluminium hydroxide adjuvant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2006

Completed
Last Updated

November 9, 2007

Status Verified

November 1, 2007

First QC Date

July 25, 2006

Last Update Submit

November 8, 2007

Conditions

Influenza

Keywords

pandemicinfluenzaH5N1vaccine

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety of pandemic inactivated influenza vaccine by different does.

Secondary Outcomes (1)

  • To evaluate the immunogenicity of pandemic inactivated influenza vaccine by different does.

Interventions

an inactivated whole virion H5N1 vaccine, adjuvantedBIOLOGICAL

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females, age from 18 to 60 years old;
  • Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process;
  • Able and willing to complete the informed consent process.

You may not qualify if:

  • Woman who is breast-feeding or planning to become pregnant during the following 210 days of study participation;
  • Persons who engage in the following occupations: culturist, slaughter, sale and forwarder of avian;
  • Subject has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc;
  • Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain;
  • Autoimmune disease or immunodeficiency;
  • Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids;
  • Diabetes mellitus (type I or II), with the exception of gestational diabetes;
  • History of thyroidectomy or thyroid disease that required medication within the past 12 months;
  • Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years;
  • Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws;
  • Malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of study;
  • Seizure disorder other than 1) febrile seizures under the age of two, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure not requiring treatment within the last 3 years;
  • Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen;
  • Guillain-Barre Syndrome (GBS);
  • Abnormal result of laboratory test as below:
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (1)

  • Lin J, Zhang J, Dong X, Fang H, Chen J, Su N, Gao Q, Zhang Z, Liu Y, Wang Z, Yang M, Sun R, Li C, Lin S, Ji M, Liu Y, Wang X, Wood J, Feng Z, Wang Y, Yin W. Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: a phase I randomised controlled trial. Lancet. 2006 Sep 16;368(9540):991-7. doi: 10.1016/S0140-6736(06)69294-5.

    PMID: 16980114RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Jiangtao Lin, MD

    China-Japan Friendship Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 25, 2006

First Posted

July 26, 2006

Study Start

December 1, 2005

Study Completion

April 1, 2006

Last Updated

November 9, 2007

Record last verified: 2007-11

Locations

CN(1)