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A single center, stratified, randomized and double-blind phase IV clinical trial is to be conducted in healthy elders (equal to or more than 61 years), adults (18-60 years), adolescents (12-17 years) and children (3-11 years) to evaluate the safety and immunogenicity of Sinovac's split-virion or whole-virion novel influenza A (H1N1) vaccines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| split-virion, adjuvanted H1N1 vaccine of 7.5 μg | Experimental | 300 participants (100 adults, 100 adolescents and 100 children) to receive split-virion, adjuvanted H1N1 vaccine of 7.5 μg on day 0 and 21. |
|
| split-virion, adjuvanted H1N1 vaccine of 15 μg | Experimental | 300 participants (100 adults, 100 adolescents and 100 children) to receive split-virion, adjuvanted H1N1 vaccine of 15 μg on day 0 and 21. |
|
| split-virion, non-adjuvanted H1N1 vaccine of 15 μg | Experimental | 300 participants (100 adults, 100 adolescents and 100 children) to receive split-virion, non-adjuvanted H1N1 vaccine of 15 μg on day 0 and 21. |
|
| split-virion, non-adjuvanted H1N1 vaccine of 30 μg | Experimental | 300 participants (100 adults, 100 adolescents and 100 children) to receive split-virion, non-adjuvanted H1N1 vaccine of 30 μg on day 0 and 21. |
|
| whole-virion, adjuvanted H1N1 vaccine of 5 μg | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| split-virion, adjuvanted H1N1 vaccine of 7.5 μg per dose | Biological | 100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 7.5μg split-virion, adjuvanted H1N1 vaccine 21 days apart. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate immunogenicity and safety of influenza A (H1N1)vaccines in elders, adults, adolescent and children . | July 2009- Sept. 2009 |
| Measure | Description | Time Frame |
|---|---|---|
| Provide a basis to determine the best type and dose of vaccine and immunization procedures | July 2009- Sept. 2009 |
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Inclusion Criteria:
Exclusion Criteria:
Cases, cured cases and close contact of influenza A (H1N1) virus
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 or seasonal influenza vaccine 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:
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 |
|---|---|---|---|
| 20632888 | Derived | Wu J, Li W, Wang HQ, Chen JT, Lv M, Zhou JC, Liang XF, Fang HH, Liu Y, Liu LY, Wang X, Zhang WL, Zhang XM, Song LF, Qiu YZ, Li CG, Wang JZ, Wang Y, Yin WD. A rapid immune response to 2009 influenza A(H1N1) vaccines in adults: a randomized, double-blind, controlled trial. J Infect Dis. 2010 Sep 1;202(5):675-80. doi: 10.1086/655226. | |
| 20018364 |
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100 adults to receive whole-virion, adjuvanted H1N1 vaccine of 5 μg on day 0 and 21. |
|
| whole-virion, adjuvanted H1N1 vaccine of 10 μg | Experimental | 200 participants: 100 adults to receive whole-virion, adjuvanted H1N1 vaccine of 10 μg on day 0 and 21. 100 elders to receive whole-virion, adjuvanted H1N1 vaccine of 10 μg on day 0 only. |
|
| Placebo control | Placebo Comparator | 100 adults to receive placebo control (Phosphate Buffer Saline) on day 0 and 21. |
|
| split-virion, adjuvanted H1N1 vaccine of 15 μg per dose | Biological | 100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 15μg split-virion, adjuvanted H1N1 vaccine 21 days apart. |
|
| split-virion, non-adjuvanted H1N1 vaccine of 15 μg per dose | Biological | 100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 15μg split-virion, non-adjuvanted H1N1 vaccine 21 days apart. |
|
| split-virion, non-adjuvanted H1N1 vaccine of 30 μg per dose | Biological | 100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 30μg split-virion, non-adjuvanted H1N1 vaccine 21 days apart. |
|
| whole-virion, adjuvanted H1N1 vaccine of 5 μg per dose | Biological | 100 adults were assigned to receive 2 doses of 5μg whole-virion, adjuvanted H1N1 vaccine 21 days apart. |
|
| whole-virion, adjuvanted H1N1 vaccine of 10 μg per dose | Biological | 100 adults were assigned to receive 2 doses of 10μg whole-virion, adjuvanted H1N1 vaccine 21 days apart. 100 elders were assigned to receive 1 doses of 10μg whole-virion, adjuvanted H1N1 vaccine |
|
| placebo control | Biological | 100 adults were assigned to receive 2 doses of placebo 21 days apart. |
|
| Liang XF, Wang HQ, Wang JZ, Fang HH, Wu J, Zhu FC, Li RC, Xia SL, Zhao YL, Li FJ, Yan SH, Yin WD, An K, Feng DJ, Cui XL, Qi FC, Ju CJ, Zhang YH, Guo ZJ, Chen PY, Chen Z, Yan KM, Wang Y. Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2010 Jan 2;375(9708):56-66. doi: 10.1016/S0140-6736(09)62003-1. Epub 2009 Dec 15. |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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