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A single center, randomized clinical trial is to be conducted in healthy adults (18-60 years) to evaluate the safety and immunogenicity and study the cell-mediated Immunity of Sinovac's H1N1 influenza A Vaccine (PANFLU.1) with Trivalent Inactivated Influenza Vaccine (ANFLU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Day 0-PANFLU.1; Day 21-ANFLU | Experimental | 50 subjects to receive-Day 0: 15 μg PANFLU.1 vaccine; Day 21: 15 μg ANFLU vaccine. |
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| Group 2: Day 0-ANFLU; Day 21-PANFLU.1 | Experimental | 50 subjects to receive-Day 0: 15 μg ANFLU vaccine; Day 21: 15 μg PANFLU.1 vaccine. |
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| Group 3: Day 0-PANFLU.1+ANFLU | Experimental | 50 subjects to receive-Day 0: 15 μg PANFLU.1 vaccine+ANFLU vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H1N1 influenza A Vaccine (PANFLU.1) | Biological | H1N1 influenza A Vaccine (PANFLU.1), 15 micrograms per dose. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) |
| Measure | Description | Time Frame |
|---|---|---|
| Study the cell-mediated immunity of H1N1 vaccine with seasonal influenza vaccine | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate immunogenicity of H1N1 vaccine with seasonal influenza vaccine in adults | 3 months | |
| Evaluate safety of H1N1 vaccine with seasonal influenza vaccine in adults | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
Cases, cured cases and close contact of influenza A (H1N1) virus
History of H1N1 vaccine or seasonal influenza vaccine administration
Women of pregnancy, lactation or about to be pregnant in 60 days
Subject that 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, hospitalization or intubation during the past two years or that required 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
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
Seizure disorder other than:
Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen
Guillain-Barre Syndrome
Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
History of any blood products 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:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Centers for Diseases Control and Prevention | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21130194 | Derived | Wu J, Zhong X, Li CK, Zhou JF, Lu M, Huang KY, Dong M, Liu Y, Luo FJ, Du N, Chui C, Liu LQ, Smith NM, Li B, Shi NM, Song LF, Gao Y, Wang DY, Wang X, Zhu WF, Yan Y, Li Z, Chen JT, McMichael AJ, Yin WD, Xu XN, Shu Y. Optimal vaccination strategies for 2009 pandemic H1N1 and seasonal influenza vaccines in humans. Vaccine. 2011 Jan 29;29(5):1009-16. doi: 10.1016/j.vaccine.2010.11.058. Epub 2010 Dec 2. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Trivalent Inactivated Influenza Vaccine (ANFLU) | Biological | Trivalent Inactivated Influenza Vaccine (ANFLU), 15 micrograms per dose. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (injected in the other arm) |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |