InfluenzaPhase 1NCT00356798
Randomized, Double Blinded, Placebo Control Clinical Trial of Pandemic Influenza Inactive Vaccine on Healthy Subjects
A Phase 1 study testing an inactivated whole virion H5N1 vaccine, adjuvanted in people with Influenza, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
Based on pre-clinical trial data and principle of GCP, the objective of phase I clinical trial is to evaluate safety and immunogenicity of Pan-flu vaccine, an inactivated whole virion H5N1 vaccine with aluminium hydroxide adjuvant. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- an inactivated whole virion H5N1 vaccine, adjuvanted
- Type of treatment
- Vaccines
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Dec 2005to Apr 2006
- Phase
- Phase 1
- 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
- Males and females, age from 18 to 60 years old;
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process;
- Able and willing to complete the informed consent process.
Who cannot join
- Woman who is breast-feeding or planning to become pregnant during the following 210 days of study participation;
- Persons who engage in the following occupations: culturist, slaughter, sale and forwarder of avian;
- Subject 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, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids;
Show all 28Show fewer
- 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;
- Malignancy that is active 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 1) febrile seizures under the age of two, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure not requiring treatment within the last 3 years;
- Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen;
- Guillain-Barre Syndrome (GBS);
- Abnormal result of laboratory test as below:
- Biochemistry assaying: Alanine Aminotransferase /Serum Glutamate Pyruvate Transaminase (ALT), Total Bilirubine Tbil (TBIL), Direct Bilirubine Tbil (DBIL), Blood Urea Nitrogen (BUN) and Creatinine (Cr).
- Routine blood assaying, routine urine assaying.
- HBsAg positive;
- Pregnancy test positive for female;
- Subject has received any of the following substances:
- 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).
- Blood products within 3 months prior to initial study vaccine administration.
- Other study drug within 30 days prior to initial study vaccine administration. Live attenuated vaccines within 30 days prior to initial study vaccine administration.
- Medically indicated subunit or killed vaccines, e.g. pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration.
- Current anti-TB prophylaxis or therapy.
- Fever before vaccination, axillary temperature 37.0 centigrades.
- 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 locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: The Phase-I Clinical Trial Protocol for the Pandemic Inactivated Influenza Vaccine
Based on pre-clinical trial data and principle of GCP, the objective of phase I clinical trial is to evaluate safety and immunogenicity of Pan-flu vaccine, an inactivated whole virion H5N1 vaccine with aluminium hydroxide adjuvant.
- Conditions
- Influenza
- Being tested
- an inactivated whole virion H5N1 vaccine, adjuvanted
- Keywords
- pandemic, influenza, H5N1, vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an inactivated whole virion H5N1 vaccine, adjuvantedBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of pandemic inactivated influenza vaccine by different does.
Secondary outcomes (1)
To evaluate the immunogenicity of pandemic inactivated influenza vaccine by different does.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2006 (estimated)
- Study startDec 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Sinovac Biotech Co., LtdThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Investigators
- Jiangtao Lin, MD, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00356798
- Sponsor's protocol ID
- PRO-PanFlu-1001
- Status last verified
- Nov 2007
- First submitted
- 25 Jul 2006
- Last updated
- 9 Nov 2007
- Results posted
- No
Publications
Lin J, Zhang J, Dong X, Fang H, Chen J, Su N, Gao Q, Zhang Z, Liu Y, Wang Z, Yang M, Sun R, Li C, Lin S, Ji M, Liu Y, Wang X, Wood J, Feng Z, Wang Y, Yin W. Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: a phase I randomised controlled trial. Lancet. 2006 Sep 16;368(9540):991-7. doi: 10.1016/S0140-6736(06)69294-5.
PubMed 16980114
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Phase-I Clinical Trial Protocol for the Pandemic Inactivated Influenza Vaccine
- ClinicalTrials.gov ID
- NCT00356798
- Acronym / sponsor ID
- PRO-PanFlu-1001
- Conditions
- Influenza
- Keywords
- pandemic, influenza, H5N1, vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Study start
- Dec 2005
- Study completion
- Apr 2006
- First posted
- 26 Jul 2006 (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.
Based on pre-clinical trial data and principle of GCP, the objective of phase I clinical trial is to evaluate safety and immunogenicity of Pan-flu vaccine, an inactivated whole virion H5N1 vaccine with aluminium hydroxide adjuvant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males and females, age from 18 to 60 years old;
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process;
- Able and willing to complete the informed consent process.
Key exclusion criteria (28 listed)
- Woman who is breast-feeding or planning to become pregnant during the following 210 days of study participation;
- Persons who engage in the following occupations: culturist, slaughter, sale and forwarder of avian;
- Subject 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;
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 |
|---|---|---|
| an inactivated whole virion H5N1 vaccine, adjuvanted | Biological | – |
Primary outcome
To evaluate the safety of pandemic inactivated influenza vaccine by different does.
1 secondary outcome
To evaluate the immunogenicity of pandemic inactivated influenza vaccine by different does.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2007.
- Results publication: PubMed 16980114Lin J, Zhang J, Dong X, Fang H, Chen J, Su N, Gao Q, Zhang Z, Liu Y, Wang Z, Yang M, Sun R, Li C, Lin S, Ji M, Liu Y, Wang X, Wood J, Feng Z, Wang Y, Yin W. Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: a phase I randomised controlled trial. Lancet. 2006 Sep 16;368(9540):991-7. doi: 10.1016/S0140-6736(06)69294-5.
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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.
Jiangtao Lin, MD principal investigator
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing an inactivated whole virion H5N1 vaccine, adjuvanted in people with Influenza, run by Sinovac Biotech Co., Ltd 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 3 inclusion and 28 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: finished, as of the sponsor's last update on 9 Nov 2007. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the safety of pandemic inactivated influenza vaccine by different does.. 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 NCT00356798, which also lists 1 linked publication.
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 9 Nov 2007.