Virus DiseasesPhase 2NCT01055990
Basic and Clinical Research on Applying Blood Fix to Treat Critical H1N1 Patients
A Phase 2 study testing split-virion, non-adjuvanted H1N1 vaccine of 15 μg and blood fix in people with Virus Diseases and Respiratory Tract Diseases, run by Shanghai Public Health Clinical Center at 1 site in China.
Trial summary
The 2009 flu pandemic is a global outbreak of a new strain of influenza A virus subtype H1N1, commonly known as swine flu, that was first identified in April 2009. Large-scale immunization is an essential approach of controlling the pandemic.Vaccines are now becoming available for protection against pandemic influenza… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Virus Diseases, Respiratory Tract Diseases, Respiratory Tract Infections
- What is being tested?
- split-virion, non-adjuvanted H1N1 vaccine of 15 μg and blood fix
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteChina
- Study dates
- Oct 2009to May 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- phase 1：
- Healthy male or female aged 18-60 years
- Volunteers are able to understand and sign the informed consent
- Be able to show legal identity card for the sake of recruitment
- Voluntarily receive a dose of influenza A (H1N1) 2009 monovalent vaccine - phase 2: 1)The donors :Healthy male or female aged 18-60 years; inoculated with specific H1N1 vaccine; titer of H1N1 hemagglutination inhibition antibody must be 1:80 or more than after examination (the kit shall be provided by the WHO) by Shanghai Municipal Center for Disease Control and Prevention 2)The patients: clinical H1N1patients with positive swab nucleic acid Real-time PCR test; critical H1N1 patients;fever less than 10 days;virus viremia was Preferred
Who cannot join
- phase 1:
- Cases or cured cases of influenza A (H1N1) virus infection
- Women of pregnancy, lactation or about to be pregnant in recency
- 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
- Autoimmune disease or immunodeficiency
- Guillain-Barre Syndrome
Show all 13Show fewer
- Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen
- 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
- Axillary temperature > 37.0 centigrade at the time of dosing
- Uncontrolled epilepsy, and other progressive neurological diseases
- Suffering from acute illness, serious chronic diseases, acute exacerbation of chronic diseases and flu
- Administration of any other investigational research agents within 30 days before the dosing
- Any other reasons that health care giver consider inappropriate to vaccination, and so on phase 2: 1)The donors :Do not meet donation requirements;the titer of H1N1 hemagglutination inhibition antibody less than 1:80 2)The patients:clinically mild H1N1 patients; fever more than 10 days;Clinicians believe that the patient was not suitable for blood fix treatment and so on
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508
About this study
Official title: Phase1 An Observational Clinical Trial With an Influenza A (H1N1) 2009 Monovalent,Split-virion Vaccine in Healthy Adults, Aged 18-60 Years Phase2 Basic and Clinical Research on Applying Blood Fix to Treat Critical H1N1 Patients
The 2009 flu pandemic is a global outbreak of a new strain of influenza A virus subtype H1N1, commonly known as swine flu, that was first identified in April 2009. Large-scale immunization is an essential approach of controlling the pandemic.Vaccines are now becoming available for protection against pandemic influenza A(H1N1) 2009 infection in some countries.In response to the pandemic, novel vaccines against the virus strain A/California/07/2009(H1N1) have been developed and recently were approved for vaccination among specific populations in China. However, the safety and effectiveness of the vaccines is of prime concern to the authorities and the public.This report details the findings of a observational clinical trial of the safety and immunogenicity of a influenza A (H1N1)2009 monovalent vaccine.
The virus of Swine Flu H1N1 that outbroke in 2009 is sensitive to neuraminidase inhibitors (Oseltamivir, zanamivir and peramivir) but have drug resistant to adamantanamine derivatives (amantadine and Flumadine), therefore neuraminidase inhibitors are recommended for antiviral therapy against Swine Flu H1N1, effect of which is evidence by the data that such drugs do modify the symptoms and decrease the death rate of H1N1 in America and Mexico. However, clinically, the investigators have encountered that this virus can infect resistant strains of Oseltamivir, which urges for a more effective treatment plan.
In view of above situations, seeking for an effective measures against H1N1 flu should be a top priority and will benefit human life and economy globally. This Topic will take the classic strategy of passive immunity to perform basic and clinical researches on applying blood fix to treat critical H1N1 patients and collect blood of healthy persons who are inoculated with specific H1N1 vaccines to cure critical H1N1 patients.
Read the detailed description
Recently, a novel swine-origin influenza A/H1N1 virus was identified as a significant cause of febrile respiratory illnesses in Mexico and the United States. It rapidly spread to many countries around the world, prompting the World Health Organization (WHO) to declare a pandemic on June 11, 2009. Antiviral drugs, such as oseltamivir or zanamivir, may be effective in treating cases of swine flu, but large-scale immunization is an essential approach of controlling the pandemic.Although preliminary evidence from a matched case-control study suggests some protection from the 2008-9 trivalent inactivated vaccine against pandemic influenza A/H1N1 2009, particularly severe forms of the disease. A vaccine against H1N1 is expected to be the most effective tool for controlling influenza A (H1N1) infection.In response to the pandemic, novel vaccines against the virus strain A/California/07/2009(H1N1) have been developed and recently were approved for vaccination among specific populations in China.The primary safety objective of this study is to assess the safety of split- virion inactivated H1N1 vaccine without adjuvant when administered at the 15 ug dose.The primary immunogenicity objective is to assess the hemagglutinin antibody and neutralizing antibody response following split- virion inactivated A(H1N1) vaccine without adjuvant. Participants 148 healthy persons age 18-60 years who have no history of novel influenza H1N1 2009 infection or novel influenza H1N1 2009 vaccination. This is an observational, Phase II study in healthy males and non-pregnant females, aged 18-60 years.This study is designed to investigate the safety and immunogenicity of an inactivated influenza H1N1 virus vaccine after approved by the Chinese Food and Drug Administration.Following immunization, safety will be measured by assessment of adverse events through 21 days. Immunogenicity testing will be hemagglutination inhibition (HI) assays and microneutralization (MN) assays on serum obtained on the day 0,7 and 21 after vaccination.In addition, we will take clinical researches on applying blood fix to treat critical H1N1 patients and collect blood of healthy persons who are inoculated with H1N1 vaccines to cure critical H1N1 patients and further observe the effectiveness and safety, for the purpose of working out a new weapon against H1N1. According to the Blood Donation Law of the People's Republic of China, the blood donation shall follow principle of voluntary.The donors should be healthy persons inoculated with specific H1N1 vaccine and their titer of H1N1 hemagglutination inhibition antibody must be 1：320 or more than after examination (the kit shall be provided by the WHO) by Shanghai Municipal Center for Disease Control and Prevention.
- Conditions
- Virus Diseases, Respiratory Tract Diseases, Respiratory Tract Infections, Influenza, Orthomyxoviridae Infections
- Being tested
- split-virion, non-adjuvanted H1N1 vaccine of 15 μg, blood fix
- Keywords
- pandemic influenza A (H1N1) 2009, blood fix treatment, influenza A (H1N1) 2009 monovalent vaccine, effectiveness, immunogenicity, safety
- Medical subject headings
- Virus Diseases, Respiratory Tract Diseases, Respiratory Tract Infections, Influenza, Human, Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
split-virion, non-adjuvanted H1N1 vaccine of 15 μgBiological
The influenza A (H1N1) 2009 monovalent, (Split-virion)inactivated vaccine was developed by Shanghai Institute of Biological Products, and the seed virus was prepared from reassortant vaccine virus A/California/7/2009,distributed by the Centers for Disease Control and Prevention in the United States. This strain was recommended by the World Health Organization and obtained from the Chinese Food and Drug Administration.The vaccine adopted the assessment of experts, and formally accessed to the approval document number of production and new drug certificate issued by the Chinese Food and Drug Administration.
blood fixOther
The blood fix with a hemagglutination-inhibition titer of 1:80 or more than was collected from healthy persons who are inoculated with specific H1N1 vaccine
| Study group | Role | What they receive |
|---|---|---|
| Heathy,aged 18-60 years, | Other | They are healthy, are 18-60 years of age, did not have a history of infection with the 2009 H1N1 virus, and are appropriate to vaccination, without any interdictions. And they guardians confirmed that they understood the study procedures, provided written informed consent, and agreed to comply with the following visit schedule. Woman participants all are not pregnant,with a negative pregnancy test before vaccination. Receives: Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg |
| clinically critical H1N1 patients | Experimental | The critical H1N1 patients as recipients whose conditions are confirmed according to current standard for critical H1N1 diagnosis. The study wll research H1N1 viral load in blood of critical H1N1 patients and swab nucleic acid testing parallelity; measure H1N1 viral Load in blood and swabs (adopting Real-time PCR method) of 5 to 10 victims; and the planned blood taking time is the tenth day since the fever begins. Receives: Other: blood fix |
What is being measured
The primary outcome is the main question the study is designed to answer.
apply blood fix to treat critical H1N1 patients and further observe the effectiveness and safety, for the purpose of working out a new weapon against H1N1
Measured: 30 minutes ahead of blood transfusion,6 hours, 12 hours, 24 hours and 48 hours after transfusion
Secondary outcomes (2)
Hemagglutination inhibition antibody titer and Microneutralization antibody titer
Measured: D0,D7,D21
local and systemic adverse reaction after vaccination
Measured: Day1-21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startOct 2009
- Primary completionApr 2010 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Virus DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Public Health Clinical Center
- Sponsor type
- Other government
- Collaborators
- Beijing Ditan Hospital, National Institute for the Control of Pharmaceutical and Biological Products, China
- Investigators
- Hong-zhou Lu, Professor, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055990
- Sponsor's protocol ID
- NCT-0015
- Status last verified
- Nov 2009
- First submitted
- 25 Jan 2010
- Last updated
- 26 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhu FC, Wang H, Fang HH, Yang JG, Lin XJ, Liang XF, Zhang XF, Pan HX, Meng FY, Hu YM, Liu WD, Li CG, Li W, Zhang X, Hu JM, Peng WB, Yang BP, Xi P, Wang HQ, Zheng JS. A novel influenza A (H1N1) vaccine in various age groups. N Engl J Med. 2009 Dec 17;361(25):2414-23. doi: 10.1056/NEJMoa0908535. Epub 2009 Oct 21.
PubMed 19846844Wu J, Fang HH, Chen JT, Zhou JC, Feng ZJ, Li CG, Qiu YZ, Liu Y, Lu M, Liu LY, Dong SS, Gao Q, Zhang XM, Wang N, Yin WD, Dong XP. Immunogenicity, safety, and cross-reactivity of an inactivated, adjuvanted, prototype pandemic influenza (H5N1) vaccine: a phase II, double-blind, randomized trial. Clin Infect Dis. 2009 Apr 15;48(8):1087-95. doi: 10.1086/597401.
PubMed 19281330Greenberg ME, Lai MH, Hartel GF, Wichems CH, Gittleson C, Bennet J, Dawson G, Hu W, Leggio C, Washington D, Basser RL. Response to a monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med. 2009 Dec 17;361(25):2405-13. doi: 10.1056/NEJMoa0907413. Epub 2009 Sep 10.
PubMed 19745216Clark TW, Pareek M, Hoschler K, Dillon H, Nicholson KG, Groth N, Stephenson I. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med. 2009 Dec 17;361(25):2424-35. doi: 10.1056/NEJMoa0907650. Epub 2009 Sep 10.
PubMed 19745215Sun F, Zhang Y, Tian D, Zheng M, Liu L, Zhang R, Dai Z, Chen J, Li T, Lu H. Responses after one dose of a monovalent influenza A (H1N1) 2009 inactivated vaccine in Chinese population--a practical observation. Vaccine. 2011 Sep 2;29(38):6527-31. doi: 10.1016/j.vaccine.2011.07.006. Epub 2011 Jul 19.
PubMed 21767595
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase1 An Observational Clinical Trial With an Influenza A (H1N1) 2009 Monovalent,Split-virion Vaccine in Healthy Adults, Aged 18-60 Years Phase2 Basic and Clinical Research on Applying Blood Fix to Treat Critical H1N1 Patients
- ClinicalTrials.gov ID
- NCT01055990
- Acronym / sponsor ID
- NCT-0015
- Conditions
- Virus Diseases, Respiratory Tract Diseases, Respiratory Tract Infections, Influenza, Orthomyxoviridae Infections
- Keywords
- pandemic influenza A (H1N1) 2009, blood fix treatment, influenza A (H1N1) 2009 monovalent vaccine, effectiveness, immunogenicity, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Shanghai Public Health Clinical CenterOther government
- Collaborators
- Beijing Ditan Hospital, National Institute for the Control of Pharmaceutical and Biological Products, China
- Study start
- Oct 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The 2009 flu pandemic is a global outbreak of a new strain of influenza A virus subtype H1N1, commonly known as swine flu, that was first identified in April 2009. Large-scale immunization is an essential approach of controlling the pandemic.Vaccines are now becoming available for protection against pandemic influenza A(H1N1) 2009 infection in some countries.In response to the pandemic, novel vaccines against the virus strain A/California/07/2009(H1N1) have been developed and recently were approved for vaccination among specific populations in China. However, the safety and effectiveness of the vaccines is of prime concern to the authorities and the public.This report details the findings of a observational clinical trial of the safety and immunogenicity of a influenza A (H1N1)2009 monovalent vaccine.
The virus of Swine Flu H1N1 that outbroke in 2009 is sensitive to neuraminidase inhibitors (Oseltamivir, zanamivir and peramivir) but have drug resistant to adamantanamine derivatives (amantadine and Flumadine), therefore neuraminidase inhibitors are recommended for antiviral therapy against Swine Flu H1N1, effect of which is evidence by the data that such drugs do modify the symptoms and decrease the death rate of H1N1 in America and Mexico. However, clinically, the investigators have encountered that this virus can infect resistant strains of Oseltamivir, which urges for a more effective treatment plan.
In view of above situations, seeking for an effective measures against H1N1 flu should be a top priority and will benefit human life and economy globally. This Topic will take the classic strategy of passive immunity to perform basic and clinical researches on applying blood fix to treat critical H1N1 patients and collect blood of healthy persons who are inoculated with specific H1N1 vaccines to cure critical H1N1 patients.
Detailed description
Recently, a novel swine-origin influenza A/H1N1 virus was identified as a significant cause of febrile respiratory illnesses in Mexico and the United States. It rapidly spread to many countries around the world, prompting the World Health Organization (WHO) to declare a pandemic on June 11, 2009. Antiviral drugs, such as oseltamivir or zanamivir, may be effective in treating cases of swine flu, but large-scale immunization is an essential approach of controlling the pandemic.Although preliminary evidence from a matched case-control study suggests some protection from the 2008-9 trivalent inactivated vaccine against pandemic influenza A/H1N1 2009, particularly severe forms of the disease. A vaccine against H1N1 is expected to be the most effective tool for controlling influenza A (H1N1) infection.In response to the pandemic, novel vaccines against the virus strain A/California/07/2009(H1N1) have been developed and recently were approved for vaccination among specific populations in China.The primary safety objective of this study is to assess the safety of split- virion inactivated H1N1 vaccine without adjuvant when administered at the 15 ug dose.The primary immunogenicity objective is to assess the hemagglutinin antibody and neutralizing antibody response following split- virion inactivated A(H1N1) vaccine without adjuvant. Participants 148 healthy persons age 18-60 years who have no history of novel influenza H1N1 2009 infection or novel influenza H1N1 2009 vaccination. This is an observational, Phase II study in healthy males and non-pregnant females, aged 18-60 years.This study is designed to investigate the safety and immunogenicity of an inactivated influenza H1N1 virus vaccine after approved by the Chinese Food and Drug Administration.Following immunization, safety will be measured by assessment of adverse events through 21 days. Immunogenicity testing will be hemagglutination inhibition (HI) assays and microneutralization (MN) assays on serum obtained on the day 0,7 and 21 after vaccination.In addition, we will take clinical researches on applying blood fix to treat critical H1N1 patients and collect blood of healthy persons who are inoculated with H1N1 vaccines to cure critical H1N1 patients and further observe the effectiveness and safety, for the purpose of working out a new weapon against H1N1. According to the Blood Donation Law of the People's Republic of China, the blood donation shall follow principle of voluntary.The donors should be healthy persons inoculated with specific H1N1 vaccine and their titer of H1N1 hemagglutination inhibition antibody must be 1：320 or more than after examination (the kit shall be provided by the WHO) by Shanghai Municipal Center for Disease Control and Prevention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heathy,aged 18-60 years, | Other | Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μgThey are healthy, are 18-60 years of age, did not have a history of infection with the 2009 H1N1 virus, and are appropriate to vaccination, without any interdictions. And they guardians confirmed that they understood the study procedures, provided written informed consent, and agreed to comply with the following visit schedule. Woman participants all are not pregnant,with a negative pregnancy test before vaccination. |
| clinically critical H1N1 patients | Experimental | Other: blood fixThe critical H1N1 patients as recipients whose conditions are confirmed according to current standard for critical H1N1 diagnosis. The study wll research H1N1 viral load in blood of critical H1N1 patients and swab nucleic acid testing parallelity; measure H1N1 viral Load in blood and swabs (adopting Real-time PCR method) of 5 to 10 victims; and the planned blood taking time is the tenth day since the fever begins. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- phase 1：
- Healthy male or female aged 18-60 years
- Volunteers are able to understand and sign the informed consent
- Be able to show legal identity card for the sake of recruitment
- Voluntarily receive a dose of influenza A (H1N1) 2009 monovalent vaccine - phase 2: 1)The donors :Healthy male or female aged 18-60 years; inoculated with specific H1N1 vaccine; titer of H1N1 hemagglutination inhibition antibody must be 1:80 or more than after examination (the kit shall be provided by the WHO) by Shanghai Municipal Center for Disease Control and Prevention 2)The patients: clinical H1N1patients with positive swab nucleic acid Real-time PCR test; critical H1N1 patients;fever less than 10 days;virus viremia was Preferred
Key exclusion criteria (13 listed)
- Cases or cured cases of influenza A (H1N1) virus infection
- Women of pregnancy, lactation or about to be pregnant in recency
- 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
- Autoimmune disease or immunodeficiency
- Guillain-Barre Syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| split-virion, non-adjuvanted H1N1 vaccine of 15 μgThe influenza A (H1N1) 2009 monovalent, (Split-virion)inactivated vaccine was developed by Shanghai Institute of Biological Products, and the seed virus was prepared from reassortant vaccine virus A/California/7/2009,distributed by the Centers for Disease Control and Prevention in the United States. This strain was recommended by the World Health Organization and obtained from the Chinese Food and Drug Administration.The vaccine adopted the assessment of experts, and formally accessed to the approval document number of production and new drug certificate issued by the Chinese Food and Drug Administration. | Biological | Heathy,aged 18-60 years, |
| blood fixThe blood fix with a hemagglutination-inhibition titer of 1:80 or more than was collected from healthy persons who are inoculated with specific H1N1 vaccine | Other | clinically critical H1N1 patients |
Primary outcome
apply blood fix to treat critical H1N1 patients and further observe the effectiveness and safety, for the purpose of working out a new weapon against H1N1
Time frame: 30 minutes ahead of blood transfusion,6 hours, 12 hours, 24 hours and 48 hours after transfusion
2 secondary outcomes
Hemagglutination inhibition antibody titer and Microneutralization antibody titer
Time frame: D0,D7,D21
local and systemic adverse reaction after vaccination
Time frame: Day1-21
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2010.
- Background: PubMed 19846844Zhu FC, Wang H, Fang HH, Yang JG, Lin XJ, Liang XF, Zhang XF, Pan HX, Meng FY, Hu YM, Liu WD, Li CG, Li W, Zhang X, Hu JM, Peng WB, Yang BP, Xi P, Wang HQ, Zheng JS. A novel influenza A (H1N1) vaccine in various age groups. N Engl J Med. 2009 Dec 17;361(25):2414-23. doi: 10.1056/NEJMoa0908535. Epub 2009 Oct 21.
- Background: PubMed 19281330Wu J, Fang HH, Chen JT, Zhou JC, Feng ZJ, Li CG, Qiu YZ, Liu Y, Lu M, Liu LY, Dong SS, Gao Q, Zhang XM, Wang N, Yin WD, Dong XP. Immunogenicity, safety, and cross-reactivity of an inactivated, adjuvanted, prototype pandemic influenza (H5N1) vaccine: a phase II, double-blind, randomized trial. Clin Infect Dis. 2009 Apr 15;48(8):1087-95. doi: 10.1086/597401.
- Background: PubMed 19745216Greenberg ME, Lai MH, Hartel GF, Wichems CH, Gittleson C, Bennet J, Dawson G, Hu W, Leggio C, Washington D, Basser RL. Response to a monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med. 2009 Dec 17;361(25):2405-13. doi: 10.1056/NEJMoa0907413. Epub 2009 Sep 10.
- Background: PubMed 19745215Clark TW, Pareek M, Hoschler K, Dillon H, Nicholson KG, Groth N, Stephenson I. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med. 2009 Dec 17;361(25):2424-35. doi: 10.1056/NEJMoa0907650. Epub 2009 Sep 10.
- Derived from this study: PubMed 21767595Sun F, Zhang Y, Tian D, Zheng M, Liu L, Zhang R, Dai Z, Chen J, Li T, Lu H. Responses after one dose of a monovalent influenza A (H1N1) 2009 inactivated vaccine in Chinese population--a practical observation. Vaccine. 2011 Sep 2;29(38):6527-31. doi: 10.1016/j.vaccine.2011.07.006. Epub 2011 Jul 19.
- Click here for more information about this disease:The Pandemic influenza A (H1N1) 2009Link provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong-zhou Lu, Professor study director
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing split-virion, non-adjuvanted H1N1 vaccine of 15 μg and blood fix in people with Virus Diseases and Respiratory Tract Diseases, run by Shanghai Public Health Clinical Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
apply blood fix to treat critical H1N1 patients and further observe the effectiveness and safety, for the purpose of working out a new weapon against H1N1 (time frame: 30 minutes ahead of blood transfusion,6 hours, 12 hours, 24 hours and 48 hours after transfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01055990, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2010.