Pandemic InfluenzaPhase 2NCT00535665
Safety and Immunogenicity of an Inactivated Pandemic Influenza Vaccine
A Phase 2 study testing pandemic influenza vaccine (H5N1 strain NIBRG-14) in people with Pandemic Influenza and Prevention, run by Sinovac Biotech Co., Ltd.
Trial summary
A single center, randomized and double-blind phase II clinical trial is to be conducted in adults to evaluate the safety and immunogenicity of an inactivated pandemic influenza vaccine (whole-virion, aluminium-adjuvanted). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pandemic Influenza, Prevention
- What is being tested?
- pandemic influenza vaccine (H5N1 strain NIBRG-14)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Nov 2007
- 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
- Healthy adults aged 18-60 years old
- Be able to show legal identity card for the sake of recruitment
- Be able to understand and sign the informed consent.
Who cannot join
- Woman： Who breast-feeding or planning to become pregnant during the 56 days of study participation
- Any history of allergic reactions was allergic to any component of the vaccine, such as eggs or ovalbumin;
- Any history of severe 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
Show all 27Show fewer
- 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
- Hypertension that was not well controlled by medication or is more than 145/95 mmHg at enrollment
- 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:
- Febrile seizures under the age of two years old,
- Seizures secondary to alcohol withdrawal more than 3 years ago, or
- 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
- Women subjects with positive urinary pregnancy test
- 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 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.
About this study
Official title: The Clinical Trial of Pandemic Influenza Vaccine (Whole-Virion， Inactivated, Adjuvanted) on Healthy Adults by Randomized and Double-Blind Design: a Phase II Study
A single center, randomized and double-blind phase II clinical trial is to be conducted in adults to evaluate the safety and immunogenicity of an inactivated pandemic influenza vaccine (whole-virion, aluminium-adjuvanted).
Read the detailed description
The vaccine to be investigated is producted in embryonated hen's eggs using an H5N1 reference strain NIBRG-14 which was prepared by NIBSC. The strain is a reassortant between A/Vietnam/1194/2004 and A/PR/8/34 by reverse genetics.
Total 400 volunteers aged from 18 to 60 years old are to be enrolled with 100 subjects in each group. The eligible volunteers will receive two doses vaccine of 5μg，10μg or 15μg haemagglutinin antigen. The schedule is day 0,14 or day 0,28. The subjects will donate their blood samples for the detection of HI antibody and microneutralization antibody. Local and systematic adverse reactions will be recorded during the study.
- Conditions
- Pandemic Influenza, Prevention
- Being tested
- pandemic influenza vaccine (H5N1 strain NIBRG-14)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pandemic influenza vaccine (H5N1 strain NIBRG-14)Biological
two-dose regimen with 14 days apart: 5 microgram per dose
pandemic influenza vaccine (H5N1 strain NIBRG-14)Biological
two-dose regimen with 28 days apart: 5 microgram per dose
pandemic influenza vaccine (H5N1 strain NIBRG-14)Biological
two-dose regimen with 28 days apart: 10 microgram per dose
pandemic influenza vaccine (H5N1 strain NIBRG-14)Biological
two-dose regimen with 28 days apart: 15 microgram per dose
| Study group | Role | What they receive |
|---|---|---|
| 1: 10 ug, 14 days | Experimental | Not described Receives: Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14) |
| 2: 5 ug, 28 days | Experimental | Not described Receives: Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14) |
| 3: 10 ug, 28 days | Experimental | Not described Receives: Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14) |
| 4: 15 ug, 28days | Experimental | Not described Receives: Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HI antibody and Neutralization antibody
Measured: 0,28,42,56
Secondary outcomes (1)
adverse reactions
Measured: 0,28,42,56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startSep 2007
- Study completionNov 2007
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 Pandemic 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centers for Disease Control and Prevention, China
- Investigators
- Jiang Wu, Principal investigator, Beijing Centers for Diseases Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535665
- Sponsor's protocol ID
- PRO-PanFlu-2001
- Status last verified
- Nov 2007
- First submitted
- 24 Sep 2007
- Last updated
- 9 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wu 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 19281330
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 Clinical Trial of Pandemic Influenza Vaccine (Whole-Virion， Inactivated, Adjuvanted) on Healthy Adults by Randomized and Double-Blind Design: a Phase II Study
- ClinicalTrials.gov ID
- NCT00535665
- Acronym / sponsor ID
- PRO-PanFlu-2001
- Conditions
- Pandemic Influenza, Prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Centers for Disease Control and Prevention, China
- Study start
- Sep 2007
- Study completion
- Nov 2007 (actual)
- First posted
- 26 Sep 2007 (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.
A single center, randomized and double-blind phase II clinical trial is to be conducted in adults to evaluate the safety and immunogenicity of an inactivated pandemic influenza vaccine (whole-virion, aluminium-adjuvanted).
Detailed description
The vaccine to be investigated is producted in embryonated hen's eggs using an H5N1 reference strain NIBRG-14 which was prepared by NIBSC. The strain is a reassortant between A/Vietnam/1194/2004 and A/PR/8/34 by reverse genetics.
Total 400 volunteers aged from 18 to 60 years old are to be enrolled with 100 subjects in each group. The eligible volunteers will receive two doses vaccine of 5μg，10μg or 15μg haemagglutinin antigen. The schedule is day 0,14 or day 0,28. The subjects will donate their blood samples for the detection of HI antibody and microneutralization antibody. Local and systematic adverse reactions will be recorded during the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1: 10 ug, 14 days | Experimental | Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14) |
| 2: 5 ug, 28 days | Experimental | Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14) |
| 3: 10 ug, 28 days | Experimental | Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14) |
| 4: 15 ug, 28days | Experimental | Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults aged 18-60 years old
- Be able to show legal identity card for the sake of recruitment
- Be able to understand and sign the informed consent.
Key exclusion criteria (27 listed)
- Woman： Who breast-feeding or planning to become pregnant during the 56 days of study participation
- Any history of allergic reactions was allergic to any component of the vaccine, such as eggs or ovalbumin;
- Any history of severe 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
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 |
|---|---|---|
| pandemic influenza vaccine (H5N1 strain NIBRG-14)two-dose regimen with 14 days apart: 5 microgram per dose | Biological | 1: 10 ug, 14 days |
| pandemic influenza vaccine (H5N1 strain NIBRG-14)two-dose regimen with 28 days apart: 5 microgram per dose | Biological | 2: 5 ug, 28 days |
| pandemic influenza vaccine (H5N1 strain NIBRG-14)two-dose regimen with 28 days apart: 10 microgram per dose | Biological | 3: 10 ug, 28 days |
| pandemic influenza vaccine (H5N1 strain NIBRG-14)two-dose regimen with 28 days apart: 15 microgram per dose | Biological | 4: 15 ug, 28days |
Primary outcome
HI antibody and Neutralization antibody
Time frame: 0,28,42,56
1 secondary outcome
adverse reactions
Time frame: 0,28,42,56
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.
- Derived from this study: 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.
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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.
Jiang Wu principal investigator
Beijing Centers for Diseases Control and Prevention
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pandemic influenza vaccine (H5N1 strain NIBRG-14) in people with Pandemic Influenza and Prevention, run by Sinovac Biotech Co., Ltd.
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 27 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.
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?
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?
HI antibody and Neutralization antibody (time frame: 0,28,42,56). 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 NCT00535665, 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.