InfluenzaPhase 2NCT01336166
The Long-term Immunogenicity of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine
A Phase 2 study testing split-virion, non-adjuvanted H1N1 vaccine of 15 μg, split-virion, non-adjuvanted H1N1 vaccine of 30 μg and split-virion, non-adjuvanted H1N1 vaccine of 45 μg in people with Influenza, run by Shanghai Institute Of Biological Products at 1 site in China.
Trial summary
The aim of this study is to investigate the long-term immunogenicity and safety of the inactivated split-virion vaccine after one immunization. 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?
- split-virion, non-adjuvanted H1N1 vaccine of 15 μg, split-virion, non-adjuvanted H1N1 vaccine of 30 μg and split-virion, non-adjuvanted H1N1 vaccine of 45 μg
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- Jul 2009to Jul 2011
- 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
- Different age groups from 18 to 60 years, with normal intelligence and health. Volunteers (or their guardians) are well informed of the situation and sign the consent
- Vaccination recipients qualified for this product have been inquired about medical history and clinically proven to be healthy
- Requests of clinical research program can be obeyed
- No other protective product is inoculated in last week
- Axillary temperature below 37 degrees Celsius
Who cannot join
- Volunteers in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
- Volunteers allergic to ingredient of vaccine composition (can be checked from vaccination history), especially to egg
- History of progressive or severe neurologic disorder
- Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Known or suspected impairment/alteration of immune function, for example receiving immunosuppressive therapy or receiving blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation
- 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
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- 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 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
- Guillain-Barre Syndrome
- Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
- Any other vaccines or immunoglobulin preparation within 1 weeks prior to enrollment
- Axillary temperature ≥ 38.0 degrees Celsius within 3 days of intended study vaccination
- Any conditions may influence the evaluation
Trial locations and contacts
1 site in 1 country.
China1 site
Hunan Provincial Center of Disease Prevention and Control
Changsha, Hunan, 410005
About this study
The aim of this study is to investigate the long-term immunogenicity and safety of the inactivated split-virion vaccine after one immunization.
- Conditions
- Influenza
- Being tested
- split-virion, non-adjuvanted H1N1 vaccine of 15 μg, split-virion, non-adjuvanted H1N1 vaccine of 30 μg, split-virion, non-adjuvanted H1N1 vaccine of 45 μg, Placebo control
- Keywords
- H1N1, Vaccine, Immunogenicity, 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, non-adjuvanted H1N1 vaccine of 15 μgBiological
120 adults were assigned to receive 1 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine.
split-virion, non-adjuvanted H1N1 vaccine of 30 μgBiological
120 adults were assigned to receive 1 dose of 30μg split-virion, non-adjuvanted H1N1 vaccine.
split-virion, non-adjuvanted H1N1 vaccine of 45 μgBiological
120 adults were assigned to receive 1 dose of 45μg split-virion, non-adjuvanted H1N1 vaccine.
Placebo controlBiological
120 adults were assigned to receive 1 dose of placebo.
| Study group | Role | What they receive |
|---|---|---|
| split-virion, non-adjuvanted vaccine of 15 μg | Experimental | split-virion, non-adjuvanted H1N1 vaccine of 15 μg. Receives: Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg |
| split-virion, non-adjuvanted vaccine of 30 μg | Experimental | split-virion, non-adjuvanted H1N1 vaccine of 30 μg. Receives: Biological: split-virion, non-adjuvanted H1N1 vaccine of 30 μg |
| split-virion, non-adjuvanted vaccine of 45 μg | Experimental | split-virion, non-adjuvanted H1N1 vaccine of 45 μg. Receives: Biological: split-virion, non-adjuvanted H1N1 vaccine of 45 μg |
| Placebo control | Placebo comparator | Placebo control Receives: Biological: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemagglutination inhibition antibody titer
Measured: Day 180
Secondary outcomes (1)
occurrence of solicited local and systemic adverse events after vaccination
Measured: Days 0-42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2011 (estimated)
- Study startJul 2009
- Primary completionJul 2011
- Study completionJul 2011
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 Shanghai Institute Of Biological ProductsThe 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
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336166
- Sponsor's protocol ID
- SIBP-2009
- Status last verified
- Oct 2015
- First submitted
- 7 Apr 2011
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Immunogenicity of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine
- ClinicalTrials.gov ID
- NCT01336166
- Acronym / sponsor ID
- SIBP-2009
- Conditions
- Influenza
- Keywords
- H1N1, Vaccine, Immunogenicity, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Shanghai Institute Of Biological ProductsIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 15 Apr 2011 (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.
The aim of this study is to investigate the long-term immunogenicity and safety of the inactivated split-virion vaccine after one immunization.
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 |
|---|---|---|
| split-virion, non-adjuvanted vaccine of 15 μg | Experimental | Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μgsplit-virion, non-adjuvanted H1N1 vaccine of 15 μg. |
| split-virion, non-adjuvanted vaccine of 30 μg | Experimental | Biological: split-virion, non-adjuvanted H1N1 vaccine of 30 μgsplit-virion, non-adjuvanted H1N1 vaccine of 30 μg. |
| split-virion, non-adjuvanted vaccine of 45 μg | Experimental | Biological: split-virion, non-adjuvanted H1N1 vaccine of 45 μgsplit-virion, non-adjuvanted H1N1 vaccine of 45 μg. |
| Placebo control | Placebo comparator | Biological: Placebo controlPlacebo control |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Different age groups from 18 to 60 years, with normal intelligence and health. Volunteers (or their guardians) are well informed of the situation and sign the consent
- Vaccination recipients qualified for this product have been inquired about medical history and clinically proven to be healthy
- Requests of clinical research program can be obeyed
- No other protective product is inoculated in last week
- Axillary temperature below 37 degrees Celsius
Key exclusion criteria (14 listed)
- Volunteers in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
- Volunteers allergic to ingredient of vaccine composition (can be checked from vaccination history), especially to egg
- History of progressive or severe neurologic disorder
- Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Known or suspected impairment/alteration of immune function, for example receiving immunosuppressive therapy or receiving blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation
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, non-adjuvanted H1N1 vaccine of 15 μg120 adults were assigned to receive 1 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine. | Biological | split-virion, non-adjuvanted vaccine of 15 μg |
| split-virion, non-adjuvanted H1N1 vaccine of 30 μg120 adults were assigned to receive 1 dose of 30μg split-virion, non-adjuvanted H1N1 vaccine. | Biological | split-virion, non-adjuvanted vaccine of 30 μg |
| split-virion, non-adjuvanted H1N1 vaccine of 45 μg120 adults were assigned to receive 1 dose of 45μg split-virion, non-adjuvanted H1N1 vaccine. | Biological | split-virion, non-adjuvanted vaccine of 45 μg |
| Placebo control120 adults were assigned to receive 1 dose of placebo. | Biological | Placebo control |
Primary outcome
Hemagglutination inhibition antibody titer
Time frame: Day 180
1 secondary outcome
occurrence of solicited local and systemic adverse events after vaccination
Time frame: Days 0-42
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 11 Sep 2018.
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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, non-adjuvanted H1N1 vaccine of 15 μg, split-virion, non-adjuvanted H1N1 vaccine of 30 μg and split-virion, non-adjuvanted H1N1 vaccine of 45 μg in people with Influenza, run by Shanghai Institute Of Biological Products 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 5 inclusion and 14 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 11 Sep 2018. 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 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?
Hemagglutination inhibition antibody titer (time frame: Day 180). 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 11 Sep 2018.