InfluenzaPhase 4NCT00956111
A Clinical Trial With Influenza A/H1N1 Vaccines
A Phase 4 study testing split-virion, adjuvanted H1N1 vaccine of 7.5 μg per dose, split-virion, adjuvanted H1N1 vaccine of 15 μg per dose and split-virion, non-adjuvanted H1N1 vaccine of 15 μg per dose 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 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… Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- split-virion, adjuvanted H1N1 vaccine of 7.5 μg per dose, split-virion, adjuvanted H1N1 vaccine of 15 μg per dose and split-virion, non-adjuvanted H1N1 vaccine of 15 μg per dose
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,614 participants
- Where
- 1 siteChina
- Study dates
- Jul 2009to Oct 2009
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy male or female aged 3 and older
- Be able to show legal identity card for the sake of recruitment
- Volunteers or their guardians are able to understand and sign the informed consent
Who cannot join
- 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
Show all 30Show 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
- 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
- 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:
- 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
Official title: A Double-blind, Randomized, Stratified and Controlled Clinical Trial With Split-virion and Whole-virion, Adjuvanted and Non-adjuvanted Influenza A/H1N1 Vaccines in Healthy Adults, Elders, Adolescents and Children
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.
- Conditions
- Influenza
- Being tested
- split-virion, adjuvanted H1N1 vaccine of 7.5 μg per dose, split-virion, adjuvanted H1N1 vaccine of 15 μg per dose, split-virion, non-adjuvanted H1N1 vaccine of 15 μg per dose, split-virion, non-adjuvanted H1N1 vaccine of 30 μg per dose, whole-virion, adjuvanted H1N1 vaccine of 5 μg per dose
- Keywords
- Novel Influenza A/H1N1 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, adjuvanted H1N1 vaccine of 7.5 μg per doseBiological
100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 7.5μg split-virion, adjuvanted H1N1 vaccine 21 days apart.
split-virion, adjuvanted H1N1 vaccine of 15 μg per doseBiological
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 doseBiological
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 doseBiological
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 doseBiological
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 doseBiological
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 controlBiological
100 adults were assigned to receive 2 doses of placebo 21 days apart.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: split-virion, adjuvanted H1N1 vaccine of 7.5 μg per dose |
| 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. Receives: Biological: split-virion, adjuvanted H1N1 vaccine of 15 μg per dose |
| 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. Receives: Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg per dose |
| 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. Receives: Biological: split-virion, non-adjuvanted H1N1 vaccine of 30 μg per dose |
| whole-virion, adjuvanted H1N1 vaccine of 5 μg | Experimental | 100 adults to receive whole-virion, adjuvanted H1N1 vaccine of 5 μg on day 0 and 21. Receives: Biological: whole-virion, adjuvanted H1N1 vaccine of 5 μg per dose |
| 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. Receives: Biological: whole-virion, adjuvanted H1N1 vaccine of 10 μg per dose |
| Placebo control | Placebo comparator | 100 adults to receive placebo control (Phosphate Buffer Saline) on day 0 and 21. Receives: Biological: placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate immunogenicity and safety of influenza A （H1N1）vaccines in elders, adults, adolescent and children .
Measured: July 2009- Sept. 2009
Secondary outcomes (1)
Provide a basis to determine the best type and dose of vaccine and immunization procedures
Measured: July 2009- Sept. 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionSep 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,614 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956111
- Sponsor's protocol ID
- PRO-PanFlu-4001
- Status last verified
- Oct 2009
- First submitted
- 10 Aug 2009
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20632888Liang 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.
PubMed 20018364
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Stratified and Controlled Clinical Trial With Split-virion and Whole-virion, Adjuvanted and Non-adjuvanted Influenza A/H1N1 Vaccines in Healthy Adults, Elders, Adolescents and Children
- ClinicalTrials.gov ID
- NCT00956111
- Acronym / sponsor ID
- PRO-PanFlu-4001
- Conditions
- Influenza
- Keywords
- Novel Influenza A/H1N1 Vaccine, Immunogenictiy, Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,614 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 11 Aug 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| split-virion, adjuvanted H1N1 vaccine of 7.5 μg | Experimental | Biological: split-virion, adjuvanted H1N1 vaccine of 7.5 μg per dose300 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 | Biological: split-virion, adjuvanted H1N1 vaccine of 15 μg per dose300 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 | Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg per dose300 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 | Biological: split-virion, non-adjuvanted H1N1 vaccine of 30 μg per dose300 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 | Biological: whole-virion, adjuvanted H1N1 vaccine of 5 μg per dose100 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 | Biological: whole-virion, adjuvanted H1N1 vaccine of 10 μg per dose200 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 | Biological: placebo control100 adults to receive placebo control (Phosphate Buffer Saline) on day 0 and 21. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male or female aged 3 and older
- Be able to show legal identity card for the sake of recruitment
- Volunteers or their guardians are able to understand and sign the informed consent
Key exclusion criteria (30 listed)
- 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
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, adjuvanted H1N1 vaccine of 7.5 μg per dose100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 7.5μg split-virion, adjuvanted H1N1 vaccine 21 days apart. | Biological | split-virion, adjuvanted H1N1 vaccine of 7.5 μg |
| split-virion, adjuvanted H1N1 vaccine of 15 μg per dose100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 15μg split-virion, adjuvanted H1N1 vaccine 21 days apart. | Biological | split-virion, adjuvanted H1N1 vaccine of 15 μg |
| split-virion, non-adjuvanted H1N1 vaccine of 15 μg per dose100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 15μg split-virion, non-adjuvanted H1N1 vaccine 21 days apart. | Biological | split-virion, non-adjuvanted H1N1 vaccine of 15 μg |
| split-virion, non-adjuvanted H1N1 vaccine of 30 μg per dose100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 30μg split-virion, non-adjuvanted H1N1 vaccine 21 days apart. | Biological | split-virion, non-adjuvanted H1N1 vaccine of 30 μg |
| whole-virion, adjuvanted H1N1 vaccine of 5 μg per dose100 adults were assigned to receive 2 doses of 5μg whole-virion, adjuvanted H1N1 vaccine 21 days apart. | Biological | whole-virion, adjuvanted H1N1 vaccine of 5 μg |
| whole-virion, adjuvanted H1N1 vaccine of 10 μg per dose100 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 | Biological | whole-virion, adjuvanted H1N1 vaccine of 10 μg |
| placebo control100 adults were assigned to receive 2 doses of placebo 21 days apart. | Biological | Placebo control |
Primary outcome
Evaluate immunogenicity and safety of influenza A （H1N1）vaccines in elders, adults, adolescent and children .
Time frame: July 2009- Sept. 2009
1 secondary outcome
Provide a basis to determine the best type and dose of vaccine and immunization procedures
Time frame: July 2009- Sept. 2009
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 29 Jul 2021.
- Derived from this study: PubMed 20632888Wu 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.
- Derived from this study: PubMed 20018364Liang 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.
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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 4 study testing split-virion, adjuvanted H1N1 vaccine of 7.5 μg per dose, split-virion, adjuvanted H1N1 vaccine of 15 μg per dose and split-virion, non-adjuvanted H1N1 vaccine of 15 μg per dose 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 30 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 29 Jul 2021. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Evaluate immunogenicity and safety of influenza A （H1N1）vaccines in elders, adults, adolescent and children . (time frame: July 2009- Sept. 2009). 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 NCT00956111, which also lists 2 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 29 Jul 2021.