InfluenzaPhase 4NCT01047202
Sinovac, Pandemic Influenza A/H1N1 Vaccine in 6 to 35 Months Infants
A Phase 4 study testing Pandemic influenza A/H1N1 vaccine and Seasonal trivalent vaccine in people with Influenza, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
A single center, observer-masked, randomized clinical trial is to be conducted in 6-35 months infants to evaluate the safety and immunogenicity of Sinovac's influenza A/H1N1 Vaccine (PANFLU.1). Read more about this study
- Who is it for?
- Ages 6 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Pandemic influenza A/H1N1 vaccine and Seasonal trivalent vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to May 2010
- 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 6 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy male or female aged between 6 and 35 months
- Full-term birth, birth weight 2,500 grams or more
- provided birth certification or vaccination card Parent(s) or legal guardian(s) are able to understand and sign the informed consent
Who cannot join
- Cases, cured cases and close contact of influenza A (H1N1) virus
- 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
- Symptoms of acute infection within a week
- Autoimmune disease or immunodeficiency
- Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)
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- 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
- 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
- History or family history of convulsions, epilepsy, brain disease and psychiatric
- Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen
- Guillain-Barre Syndrome
- Administration of 2009-2010 seasonal vaccine
- History of any blood products within 3 months
- Administration of any other investigational research agents within 30 days
- Administration of any live attenuated vaccine within 30 days
- Administration of subunit or inactivated vaccines within 14 days
- Be receiving anti-TB prophylaxis or therapy currently
- Axillary temperature > 37.0 centigrade at the time of dosing
- 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 Blinded, Randomized and Controlled Clinical Trial With Influenza A/H1N1 Split-virion Vaccine in 6 to 35 Months Infants
A single center, observer-masked, randomized clinical trial is to be conducted in 6-35 months infants to evaluate the safety and immunogenicity of Sinovac's influenza A/H1N1 Vaccine (PANFLU.1).
- Conditions
- Influenza
- Being tested
- Pandemic influenza A/H1N1 vaccine, Seasonal trivalent 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.
Pandemic influenza A/H1N1 vaccineBiological
Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose
Pandemic influenza A/H1N1 vaccineBiological
Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose
Seasonal trivalent vaccineBiological
Trivalent Inactivated Influenza Vaccine (ANFLU), 7.5 micrograms of each strain per dose per 0.25 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 7.5 μg pandemic influenza A/H1N1 vaccine | Experimental | 120 subjects to receive two doses of 7.5 μg pandemic influenza A/H1N1 vaccine 21 days apart Receives: Biological: Pandemic influenza A/H1N1 vaccine |
| Group 2 : 15 μg pandemic influenza A/H1N1 vaccine | Experimental | 120 subjects to receive two doses of 15 μg pandemic influenza A/H1N1 vaccine 21 days apart Receives: Biological: Pandemic influenza A/H1N1 vaccine |
| Group 3 : 7.5 μg seasonal trivalent vaccine | Sham comparator | 60 subjects to receive two doses of 7.5 μg seasonal trivalent vaccine 21 days apart Receives: Biological: Seasonal trivalent vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate immunogenicity of H1N1 vaccine with seasonal influenza vaccine in infants
Measured: 3 months
Secondary outcomes (1)
Evaluate safety of H1N1 vaccine with seasonal influenza vaccine in infants
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionMar 2010
- Study completionMay 2010
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 310 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
- NCT01047202
- Sponsor's protocol ID
- PRO-PanFlu-4003
- Status last verified
- Mar 2013
- First submitted
- 11 Jan 2010
- Last updated
- 15 Mar 2013
- Results posted
- No
Publications
Li YP, Li W, Liang XF, Liu Y, Huang XC, Li CG, Li RC, Wang JZ, Wang HQ, Yin WD. Immunogenicity and safety of a 2009 pandemic influenza A (H1N1) monovalent vaccine in Chinese infants aged 6-35 months: a randomized, double-blind, controlled phase I clinical trial. Influenza Other Respir Viruses. 2013 Nov;7(6):1297-307. doi: 10.1111/irv.12028. Epub 2012 Nov 8.
PubMed 23134570
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blinded, Randomized and Controlled Clinical Trial With Influenza A/H1N1 Split-virion Vaccine in 6 to 35 Months Infants
- ClinicalTrials.gov ID
- NCT01047202
- Acronym / sponsor ID
- PRO-PanFlu-4003
- Conditions
- Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 12 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.
A single center, observer-masked, randomized clinical trial is to be conducted in 6-35 months infants to evaluate the safety and immunogenicity of Sinovac's influenza A/H1N1 Vaccine (PANFLU.1).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: 7.5 μg pandemic influenza A/H1N1 vaccine | Experimental | Biological: Pandemic influenza A/H1N1 vaccine120 subjects to receive two doses of 7.5 μg pandemic influenza A/H1N1 vaccine 21 days apart |
| Group 2 : 15 μg pandemic influenza A/H1N1 vaccine | Experimental | Biological: Pandemic influenza A/H1N1 vaccine120 subjects to receive two doses of 15 μg pandemic influenza A/H1N1 vaccine 21 days apart |
| Group 3 : 7.5 μg seasonal trivalent vaccine | Sham comparator | Biological: Seasonal trivalent vaccine60 subjects to receive two doses of 7.5 μg seasonal trivalent vaccine 21 days apart |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy male or female aged between 6 and 35 months
- Full-term birth, birth weight 2,500 grams or more
- provided birth certification or vaccination card Parent(s) or legal guardian(s) are able to understand and sign the informed consent
Key exclusion criteria (19 listed)
- Cases, cured cases and close contact of influenza A (H1N1) virus
- 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
- Symptoms of acute infection within a week
- 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 |
|---|---|---|
| Pandemic influenza A/H1N1 vaccinePandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose | Biological | Group 1: 7.5 μg pandemic influenza A/H1N1 vaccine |
| Pandemic influenza A/H1N1 vaccinePandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose | Biological | Group 2 : 15 μg pandemic influenza A/H1N1 vaccine |
| Seasonal trivalent vaccineTrivalent Inactivated Influenza Vaccine (ANFLU), 7.5 micrograms of each strain per dose per 0.25 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose | Biological | Group 3 : 7.5 μg seasonal trivalent vaccine |
Primary outcome
Evaluate immunogenicity of H1N1 vaccine with seasonal influenza vaccine in infants
Time frame: 3 months
1 secondary outcome
Evaluate safety of H1N1 vaccine with seasonal influenza vaccine in infants
Time frame: 3 months
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 15 Mar 2013.
- Derived from this study: PubMed 23134570Li YP, Li W, Liang XF, Liu Y, Huang XC, Li CG, Li RC, Wang JZ, Wang HQ, Yin WD. Immunogenicity and safety of a 2009 pandemic influenza A (H1N1) monovalent vaccine in Chinese infants aged 6-35 months: a randomized, double-blind, controlled phase I clinical trial. Influenza Other Respir Viruses. 2013 Nov;7(6):1297-307. doi: 10.1111/irv.12028. Epub 2012 Nov 8.
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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 Pandemic influenza A/H1N1 vaccine and Seasonal trivalent vaccine 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 19 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 15 Mar 2013. 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 of H1N1 vaccine with seasonal influenza vaccine in infants (time frame: 3 months). 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 NCT01047202, 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 15 Mar 2013.