Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza(H5N1)Vaccine

Sinovac

Status and phase

Completed

Phase 1

Conditions

Prevention

Pandemic Influenza

Pandemic Influenza Vaccine

Treatments

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

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00660257

PRO-PanFlu-1002

Details and patient eligibility

About

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).

Enrollment

57 patients

Sex

All

Ages

19 to 61 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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
Axillary temperature >37.0 centigrade at the time of dosing
Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment
Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

57 participants in 4 patient groups

No.1: 1.25 ug

Experimental group

Treatment:

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

No.2: 2.5 ug

Experimental group

Treatment:

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

No.3: 5.0 ug

Experimental group

Treatment:

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

No. 4: 10 ug

Experimental group

Treatment:

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

Trial contacts and locations

1

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