H7N9 InfluenzaPhase 2NCT03755427
A Study of An Adjuvanted Inactivated H7N9 Influenza Vaccine
A Phase 2 study testing 15μg H7N9 Vaccine and Aluminum Hydroxide Adjuvant in people with H7N9 Influenza, run by Shanghai Institute Of Biological Products at 1 site in China.
Trial summary
The aim of this study is to investigate the immunogenicity and safety of the inactivated whole-virion vaccine for teenagers and adults. The investigators will test the vaccine in participants aged above 12 years, for a randomized, blind, placebo-controlled, clinical study. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- H7N9 Influenza
- What is being tested?
- 15μg H7N9 Vaccine and Aluminum Hydroxide Adjuvant
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 560 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2018to 15 Nov 2019
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Over the age of 12 years, healthy population
- Subjects/ (and the guardian) informed consent, voluntarily participated and signed the informed consent form, with the ability to use thermometers, scales and to fill in diary cards as required
- To comply with the requirements of clinical trial program, receive blood test before and after immunization and cooperate with follow-up
Who cannot join
- A history of influenza A (H7N9) virus infection or suspected infection Abnormal blood routine, blood biochemistry and urine routine examination indexes
- Allergy to any component in the vaccine (allergy history of any previous vaccination), especially for egg allergy
- History of asthma, history of thyroid resection, vascular nerve edema, diabetes mellitus, hypertension can not be controlled by medicine, liver and kidney diseases or malignant tumor history
- Suffered from any serious illness, such as cancer, autoimmune disease, progressive atherosclerotic disease or complications of diabetes, chronic obstructive pulmonary disease, need oxygen therapy for acute or progressive liver or kidney disease, congestive heart-failure etc.
- History of signs disease or symptoms of neurological symptoms
- Suffering from severe chronic diseases (such as Down's syndrome, diabetes, sicklemia or neurological disorders, Green's Barre syndrome)
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- Acute attacks of various acute or chronic diseases in the past 7 days
- Known or suspected of respiratory disease, acute infection or chronic disease active period, HIV infection, cardiovascular disease, severe hypertension, malignant tumor during treatment, skin diseases
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition etc
- No spleen, functional absence of spleen, and splenectomy or splenectomy without any condition
- Autoimmune diseases or immunodeficiency have been treated with immunosuppressive agents in the past 6 months
- History of epilepsy, convulsions, or a family history of psychosis
- Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities), or obvious bruising or coagulopathy
- The blood products were received within 3 months prior to the acceptance of the vaccine
- Received a live vaccine within 14 days prior to receiving the vaccine, or received a subunit or inactivated vaccine within 7 days
- Fever within 3 days prior to vaccination, axillary temperature ≥38 ℃
- Being febrile When inoculating vaccine, axillary temperature >37.0 ℃
- Women are pregnant or in the near future planned pregnancy or pregnancy test positive
- Participants in another clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site
Suiping Center for Disease Control and Prevention
Zhumadian, Henan, 463100
About this study
Official title: Immunogenicity and Safety of an Alum-adjuvanted Inactivated H7N9 Influenza Vaccine: a Randomized, Blind, Placebo-controlled, a Phase II Clinical Trial
The aim of this study is to investigate the immunogenicity and safety of the inactivated whole-virion vaccine for teenagers and adults.
The investigators will test the vaccine in participants aged above 12 years, for a randomized, blind, placebo-controlled, clinical study. The investigators designed one dosage groups: 15 μg of hemagglutinin antigen. Control group is designed to inoculate seasonal influence vaccine and aluminum hydroxide adjuvant. Participants will receive 2 doses of vaccine at 21-day intervals. Safety up to 6 months and changes in hemagglutinin inhibition (HI) titers at 21 days after each vaccination will be determined.
- Conditions
- H7N9 Influenza
- Being tested
- 15μg H7N9 Vaccine, Aluminum Hydroxide Adjuvant
- Keywords
- H7N9
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15μg H7N9 VaccineBiological
The vaccine was a inactivated, whole virion preparation of the influenza A/Shanghai/2/2013(H7N9) virus, propagated in embryonated chicken eggs，mixed with aluminum hydroxide adjuvant.
Aluminum Hydroxide AdjuvantBiological
The seasonal influenza vaccine was a inactivated, split virion preparation of the influenza virus, propagated in embryonated chicken eggs. The aluminum hydroxide adjuvant was 0.5ml aluminum hydroxide adjuvant.
| Study group | Role | What they receive |
|---|---|---|
| 15μg H7N9 Vaccine | Experimental | Participants will be inoculated with 2 doses of 15μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals. Receives: Biological: 15μg H7N9 Vaccine |
| Aluminum hydroxide adjuvant | Placebo comparator | Participants will be first inoculated with one dose of seasonal influenza vaccine and followed with one dose of aluminum hydroxide adjuvant at 21-day intervals. Receives: Biological: Aluminum Hydroxide Adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs)
- For each group the incidence rate of subjects with solicited AE(s) with 95% confidence interval
- For each group the incidence rate of subjects with unsolicited AE(s) with 95% confidence interval
Measured: Continuous observation for 30 days after two inoculations
Secondary outcomes (3)
Number of participants that presented seroconversion post injection
- Seroconvertion is defined as: prevaccination Hemagglutination-inhibition test (HI) antibody titer ≤1:10 and postvaccination HI antibody titer ≥1:40, or prevaccination HI antibody titer ≥1:10 and a postvaccination increase by a factor of four or more.
- Participants will be collected blood post first study injection, when blood samples will be taken for HI testing
Measured: 21 days after two inoculations
Number of participants that presented seroprotection post injection
- Seroprotection is defined as postvaccination Hemagglutination-inhibition test (HI) antibody titer ≥ 1:40.
- Participants will be collected blood post first study injection, when blood samples will be taken for HI testing
Measured: 21 days after two inoculations
Geometric mean of Hemagglutination-inhibition titre post first study injection
- Geometric mean of Hemagglutination-inhibition test titre will be calculated for the different groups of participants post first study injection.
- Participants will be collected blood post first study injection, when blood samples will be taken for HI testing.
Measured: 21 days after two inoculations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start10 Nov 2018
- Primary completion5 Jan 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H7N9 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
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xia Shengli, PhD, Principal investigator, Henan Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755427
- Sponsor's protocol ID
- 2016L09902/3-2
- Status last verified
- Oct 2024
- First submitted
- 14 Nov 2018
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of an Alum-adjuvanted Inactivated H7N9 Influenza Vaccine: a Randomized, Blind, Placebo-controlled, a Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT03755427
- Acronym / sponsor ID
- 2016L09902/3-2
- Conditions
- H7N9 Influenza
- Keywords
- H7N9
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Shanghai Institute Of Biological ProductsIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 5 Jan 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 28 Nov 2018 (actual)
- 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 immunogenicity and safety of the inactivated whole-virion vaccine for teenagers and adults.
The investigators will test the vaccine in participants aged above 12 years, for a randomized, blind, placebo-controlled, clinical study. The investigators designed one dosage groups: 15 μg of hemagglutinin antigen. Control group is designed to inoculate seasonal influence vaccine and aluminum hydroxide adjuvant. Participants will receive 2 doses of vaccine at 21-day intervals. Safety up to 6 months and changes in hemagglutinin inhibition (HI) titers at 21 days after each vaccination will be determined.
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 |
|---|---|---|
| 15μg H7N9 Vaccine | Experimental | Biological: 15μg H7N9 VaccineParticipants will be inoculated with 2 doses of 15μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals. |
| Aluminum hydroxide adjuvant | Placebo comparator | Biological: Aluminum Hydroxide AdjuvantParticipants will be first inoculated with one dose of seasonal influenza vaccine and followed with one dose of aluminum hydroxide adjuvant at 21-day intervals. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Over the age of 12 years, healthy population
- Subjects/ (and the guardian) informed consent, voluntarily participated and signed the informed consent form, with the ability to use thermometers, scales and to fill in diary cards as required
- To comply with the requirements of clinical trial program, receive blood test before and after immunization and cooperate with follow-up
Key exclusion criteria (19 listed)
- A history of influenza A (H7N9) virus infection or suspected infection Abnormal blood routine, blood biochemistry and urine routine examination indexes
- Allergy to any component in the vaccine (allergy history of any previous vaccination), especially for egg allergy
- History of asthma, history of thyroid resection, vascular nerve edema, diabetes mellitus, hypertension can not be controlled by medicine, liver and kidney diseases or malignant tumor history
- Suffered from any serious illness, such as cancer, autoimmune disease, progressive atherosclerotic disease or complications of diabetes, chronic obstructive pulmonary disease, need oxygen therapy for acute or progressive liver or kidney disease, congestive heart-failure etc.
- History of signs disease or symptoms of neurological symptoms
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 |
|---|---|---|
| 15μg H7N9 VaccineThe vaccine was a inactivated, whole virion preparation of the influenza A/Shanghai/2/2013(H7N9) virus, propagated in embryonated chicken eggs，mixed with aluminum hydroxide adjuvant. | Biological | 15μg H7N9 Vaccine |
| Aluminum Hydroxide AdjuvantThe seasonal influenza vaccine was a inactivated, split virion preparation of the influenza virus, propagated in embryonated chicken eggs. The aluminum hydroxide adjuvant was 0.5ml aluminum hydroxide adjuvant. | Biological | Aluminum hydroxide adjuvant |
Primary outcome
Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs)
Time frame: Continuous observation for 30 days after two inoculations
* For each group the incidence rate of subjects with solicited AE(s) with 95% confidence interval * For each group the incidence rate of subjects with unsolicited AE(s) with 95% confidence interval
3 secondary outcomes
Number of participants that presented seroconversion post injection
Time frame: 21 days after two inoculations
Number of participants that presented seroprotection post injection
Time frame: 21 days after two inoculations
Geometric mean of Hemagglutination-inhibition titre post first study injection
Time frame: 21 days after two inoculations
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 16 Oct 2024.
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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.
Xia Shengli, PhD principal investigator
Henan Center for Disease Control and Prevention
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 15μg H7N9 Vaccine and Aluminum Hydroxide Adjuvant in people with H7N9 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 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 16 Oct 2024. 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?
Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs) (time frame: Continuous observation for 30 days after two inoculations). 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 16 Oct 2024.