NCT00660257

Brief Summary

A single center, non-randomized clinical trial in two-dose primed healthy adults to evaluate the safety and immunogenicity of a booster dose of an inactivated pandemic influenza (H5N1) vaccine (whole-virion, aluminium-adjuvanted).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2007

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

January 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2008

Completed
Last Updated

April 17, 2008

Status Verified

April 1, 2008

Enrollment Period

2 months

First QC Date

April 15, 2008

Last Update Submit

April 16, 2008

Conditions

Pandemic Influenza VaccinePreventionPandemic Influenza

Outcome Measures

Primary Outcomes (1)

  • HI antibody Neutralization antibody

    15 and 30 days after the booster dose

Secondary Outcomes (1)

  • local adverse reactions systemic adverse reactions temperature

    3 days after booster dose

Study Arms (4)

No.1: 1.25 ug

EXPERIMENTAL
Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)

No.2: 2.5 ug

EXPERIMENTAL
Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)

No.3: 5.0 ug

EXPERIMENTAL
Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)

No. 4: 10 ug

EXPERIMENTAL
Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)

Interventions

pandemic influenza vaccine (H5N1 strain NIBRG-14)BIOLOGICAL

pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection

No.1: 1.25 ug

Eligibility Criteria

Age19 Years - 61 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Had received two-dose priming vaccination in previous phase I trial
  • Be able to show legal identity card for the sake of recruitment
  • Be able to understand and sign the informed consent.

You may not qualify if:

  • Woman： Who breast-feeding or planning to become pregnant during the study
  • Any history of allergic reactions to vaccines or eggs
  • Autoimmune disease or immunodeficiency
  • Diabetes mellitus (type I or II), with the exception of gestational diabetes
  • Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
  • Hypertension that was not well controlled by medication or is more than 145/95 mmHg at enrollment
  • Active malignancy 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
  • Guillain-Barre Syndrome
  • Women subjects with positive urinary pregnancy test
  • Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months
  • History of any blood products administration within 3 months before the dosing
  • Administration of any other investigational research agents within 30 days before the dosing
  • Administration of any live attenuated vaccine within 30 days before the dosing
  • Administration of subunit or inactivated vaccines, e.g. pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing
  • Be receiving anti-TB prophylaxis or therapy currently
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

  • Lin JT, Li CG, Wang X, Su N, Liu Y, Qiu YZ, Yang M, Chen JT, Fang HH, Dong XP, Yin WD, Feng ZJ. Antibody persistence after 2-dose priming and booster response to a third dose of an inactivated, adjuvanted, whole-virion H5N1 vaccine. J Infect Dis. 2009 Jan 15;199(2):184-7. doi: 10.1086/595832.

    PMID: 19067606DERIVED

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 15, 2008

First Posted

April 17, 2008

Study Start

January 1, 2007

Primary Completion

March 1, 2007

Study Completion

March 1, 2008

Last Updated

April 17, 2008

Record last verified: 2008-04

Locations

CN(1)