InfluenzaPhase 2NCT00900991
Safety and Immunogenicity of a Split-Virion Pandemic Influenza A (H5N1) Vaccine in Children
A Phase 2 study testing split-virion pandemic influenza vaccine (H5N1 strain NIBRG-14) in people with Influenza, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
A single center, stratified, randomized and double-blind phase II clinical trial was conducted in children to evaluate the safety and immunogenicity of an split-virion pandemic influenza A vaccine (H5N1). Read more about this study
- Who is it for?
- Ages 3 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- split-virion 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
- Not given
- Where
- 1 siteChina
- Study dates
- Start not givento not given
- 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 3 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 3-11 years old
- Be able to show legal identity card for the sake of recruitment
- Volunteers or their parents are able to understand and sign the informed consent
- Do not participate in other clinical trial
Who cannot join
- Any history of allergic reactions
- 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
Show all 28Show fewer
- Hypertension that was not well controlled by medication or the blood pressure 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 of 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 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
- 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.
About this study
A single center, stratified, randomized and double-blind phase II clinical trial was conducted in children to evaluate the safety and immunogenicity of an split-virion pandemic influenza A vaccine (H5N1).
- Conditions
- Influenza
- Being tested
- split-virion pandemic influenza vaccine (H5N1 strain NIBRG-14)
- Keywords
- Pandemic Influenza A Vaccine, Immunogenictiy, Safety
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
split-virion pandemic influenza vaccine (H5N1 strain NIBRG-14)Biological
| Study group | Role | What they receive |
|---|---|---|
| 10 ug | Experimental | 10 microgram per dose Receives: Biological: split-virion pandemic influenza vaccine (H5N1 strain NIBRG-14) |
| 15 ug | Experimental | 15 microgram per dose Receives: Biological: split-virion 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
Secondary outcomes (1)
Adverse reactions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centers for Disease Control and Prevention, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900991
- Sponsor's protocol ID
- PRO-sPanFlu-2002
- Status last verified
- May 2009
- First submitted
- 12 May 2009
- Last updated
- 14 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of a Split-Virion Pandemic Influenza A (H5N1) Vaccine in Children
- ClinicalTrials.gov ID
- NCT00900991
- Acronym / sponsor ID
- PRO-sPanFlu-2002
- Conditions
- Influenza
- Keywords
- Pandemic Influenza A Vaccine, Immunogenictiy, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Centers for Disease Control and Prevention, China
- First posted
- 13 May 2009 (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, stratified, randomized and double-blind phase II clinical trial was conducted in children to evaluate the safety and immunogenicity of an split-virion pandemic influenza A vaccine (H5N1).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 ug | Experimental | Biological: split-virion pandemic influenza vaccine (H5N1 strain NIBRG-14)10 microgram per dose |
| 15 ug | Experimental | Biological: split-virion pandemic influenza vaccine (H5N1 strain NIBRG-14)15 microgram per dose |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy children aged 3-11 years old
- Be able to show legal identity card for the sake of recruitment
- Volunteers or their parents are able to understand and sign the informed consent
- Do not participate in other clinical trial
Key exclusion criteria (28 listed)
- Any history of allergic reactions
- 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
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 pandemic influenza vaccine (H5N1 strain NIBRG-14) | Biological | 10 ug, 15 ug |
Primary outcome
HI antibody and Neutralization antibody
1 secondary outcome
Adverse reactions
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 14 May 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 pandemic influenza vaccine (H5N1 strain NIBRG-14) 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 4 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 14 May 2009. 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?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2009.