Pandemic Influenza, Pandemic Influenza Vaccine, Prevention
Conditions
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).
Interventions
pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection
Sponsors
Centers for Disease Control and Prevention, China
Sinovac Biotech Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 61 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HI antibody Neutralization antibody | 15 and 30 days after the booster dose |
Secondary
| Measure | Time frame |
|---|---|
| local adverse reactions systemic adverse reactions temperature | 3 days after booster dose |
Countries
China
Outcome results
None listed