Influenza APhase 1NCT03196661
Preliminary Study on Safety and Immunogenicity of Influenza A (H7N9) Vaccine in the Population
A Phase 1 study testing Influenza A (H7N9) virus vaccine in people with Influenza A, run by Hualan Biological Bacterin Co. Ltd..
Trial summary
Adopt the design of random, blind method and placebo to parallel control and progressive methods of groups to study and evaluate the safety and immunogenicity of influenza A (H7N9) vaccine (two types, one type with two specifications) on people of different ages. Read more about this study
- Who is it for?
- Ages 3 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza A
- What is being tested?
- Influenza A (H7N9) virus vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 588 participants
- Where
- No sites listed yet
- Study dates
- 6 Nov 2015to 23 Mar 2017
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Permanent healthy residents with normal intelligence meet the minimum age requirement. Literate and willing to provide written informed consent.
- A signed informed consent.
- Willing to comply with the rules of the clinical trial scheme. Accept the blood examination before and after immunization and cooperate follow-up visit.
Who cannot join
- Exclusion criteria of the first vaccination A person with a history of H7N9 virus infection or suspected infection; Who is allergic to any component of trial vaccine (and past history of any allergy vaccination), especially allergic to eggs; No spleen, or the spleen isn't working; Autoimmune diseases or immunodeficiency, have been treated with immunosuppressant over the past six months; Acute attack of acute illness or chronic disease in almost 7 days; Accept blood products in three months before getting inoculated testing vaccine; Got inoculated active virus vaccine in 14 days or subtype or inactivated virus in 7 days before getting inoculated testing vaccine; Who had been infected by any acute diseases ;
- Who had fever in past 3 days (axillary temperature ≥ 38 ℃);
- Who is participating another clinical trial
- Who had allergies, convulsions, epilepsy, encephalopathy, psychosis history or family history;
- Who is suffering from thrombocytopenia or other coagulation disorder, which may result to intramuscular injection contraindication; The laboratory detection indexes are abnormal before getting inoculated testing vaccine; The females are in suckling period, pregnancy, plan of pregnant or pregnancy tests (positive).
- Who had fever in the past 3 days (axillary temperature ≥ 37.1 ℃). Any other situations investigator think about may affect trial evaluation. Exclusion criteria of the second vaccination Level 3 and above allergic reactions (local and general side effect, vital signs and abnormal laboratory index) related to vaccine were appeared after the first vaccination.
- Level 2 and above allergic reactions related to vaccine were appeared after the first vaccination.
- -Any other situations investigator think about may affect trial evaluation.
About this study
Adopt the design of random, blind method and placebo to parallel control and progressive methods of groups to study and evaluate the safety and immunogenicity of influenza A (H7N9) vaccine (two types, one type with two specifications) on people of different ages. The vaccines used for testing include: influenza A (H7N9) virus inactivated vaccine/split influenza vaccine (15μg /dose), influenza A (H7N9) virus inactivated vaccine/split influenza vaccine (30μg / dose), influenza A (H7N9) virus inactivated vaccine/whole influenza vaccine (7.5μg / dose) and influenza A (H7N9) virus inactivated vaccine/ whole influenza vaccine (15μg / dose).
The study between different subgroups was carried out in an orderly and progressive manner, that is, each kind of vaccine by the dose is from low to high according to the order of age from old to young. Firstly, the study on 15μg/dose split vaccine group (aged 18 and above) and 7.5μg/dose whole-virus vaccine group (aged 18 and above) was carried out and then the study on 15μg/dose split vaccine group (aged 12-17) and 7.5μg/dose whole-virus vaccine group (aged 12-17) was conducted upon 7-day safety was confirmed after the vaccination, finally the study on 30μg/dose split vaccine group (aged 18 and above) and 15μg/dose whole-virus vaccine group (aged 18 and above) was done. By that analogy for the same conditions, the next group of test can be done after the 7-day safety of the last group of vaccine is confirmed.
Subjects and researchers didn't know the formulations of the vaccines used. The vaccine is injected into the upper arm deltoid muscle. After 30 minutes of field observation on safety, the subjects' axillary temperature shall be recorded on the Record Book prepared by the research and local and systemic reactions to injection at the 6th, 24th, 48th, and 72th hour and on the 4th, 8th, 21st and 30th day shall also be recorded. This paper collected 5 serum samples: day 0 (before the first-dose vaccination), day 4 (after the first-dose vaccination), day 21 (before the second-dose vaccination), day 25 (fourth day after the second-dose vaccination) and day 42 (21st day after the second-dose vaccination), of which, blood samples on day 0, 21 and 42 should be stored at 18℃ for antibody detection and the remaining 2 blood samples are only used for blood routine examination, routine urine test, blood biochemistry and other laboratory examinations.
- Conditions
- Influenza A
- Being tested
- Influenza A (H7N9) virus vaccine
- Keywords
- safety investigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza A (H7N9) virus vaccineBiological
To prevent the infection of H7N9 virus.
| Study group | Role | What they receive |
|---|---|---|
| H7N9 split influenza vaccine (15μg/dose) | Placebo comparator | This group was divided into three subgroups according ages of subjects, the ages of those subjects are: 3 to 11(36 subjects got inoculated test vaccines, 18 subjects got inoculated reference vaccines)，12 to 17(36 subjects got inoculated test vaccines, 12 subjects got inoculated reference vaccines)，≥18 (36 subjects got inoculated test vaccines, 12 subjects got inoculated reference vaccines).
Immune procedure: 0,21st day; Physical examination: 0,4th, 21st,25th day; Antibody detection: 0,21st,42nd day. Receives: Biological: Influenza A (H7N9) virus vaccine |
| H7N9 split influenza vaccine (30μg/dose) | Placebo comparator | This group was divided into three subgroups according ages of subjects, the ages of those subjects are: 3 to 11(36 subjects got inoculated test vaccines, 18 subjects got inoculated reference vaccines)，12 to 17(36 subjects got inoculated test vaccines, 12 subjects got inoculated reference vaccines)，≥18 (36 subjects got inoculated test vaccines, 12 subjects got inoculated reference vaccines).
Immune procedure: 0,21st day; Physical examination: 0,4th, 21st,25th day; Antibody detection: 0,21st,42nd day. Receives: Biological: Influenza A (H7N9) virus vaccine |
| H7N9 whole virus influenza vaccine (7.5μg/dose) | Placebo comparator | This group was divided into two subgroups according ages of subjects, the ages of those subjects are: 12 to 17(54 subjects got inoculated test vaccines,18 subjects got inoculated reference vaccines)，≥18 (54 subjects got inoculated test vaccines, 18 subjects got inoculated reference vaccines).
Immune procedure: 0,21st day; Physical examination: 0,4th, 21st,25th day; Antibody detection: 0,21st,42nd day. Receives: Biological: Influenza A (H7N9) virus vaccine |
| H7N9 whole virus influenza vaccine (15μg/dose) | Placebo comparator | This group was divided into two subgroups according ages of subjects, the ages of those subjects are: 12 to 17(54 subjects got inoculated test vaccines,18 subjects got inoculated reference vaccines)，≥18 (54 subjects got inoculated test vaccines, 18 subjects got inoculated reference vaccines).
Immune procedure: 0,21st day; Physical examination: 0,4th, 21st,25th day; Antibody detection: 0,21st,42nd day. Receives: Biological: Influenza A (H7N9) virus vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
587 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.
Inspect the measures like pain, induration, redness, red and swollen, rash, pruritus, skin mucosa reaction, etc. All these data is collected through questionnaires.
Measured: 20 days after the inoculation of first needle
587 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.
Inspect the measures like pain, induration, redness, red and swollen, rash, pruritus, skin mucosa reaction, etc. All these data is collected through questionnaires.
Measured: 30 days after the inoculation of second needle
587 subjects accept the observation of systemic adverse reactions according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.
Inspect the measures like fever, headache, fatigue, weak, nausea, diarrhea, cough, allergic reaction, etc. All these data is collected through questionnaires.
Measured: 20 days after the inoculation of first needle
587 subjects accept the observation of systemic adverse reactions according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.
Inspect the measures like fever, headache, fatigue, weak, nausea, diarrhea, cough, allergic reaction, etc. All these data is collected through questionnaires.
Measured: 30 days after the inoculation of second needle
Secondary outcomes (2)
558 subjects accept the immunogenicity test according to micro-hemagglutination-inhibition test.
China pharmaceutical biological products analysis institute tests the HI antibody titer of H7N9 influenza virus in blood samples by adopting internationally-used micro-hemagglutination-inhibition test.
Measured: 21 days after the inoculation of first needle
558 subjects accept the immunogenicity test according to micro-hemagglutination-inhibition test.
China pharmaceutical biological products analysis institute tests the HI antibody titer of H7N9 influenza virus in blood samples by adopting internationally-used micro-hemagglutination-inhibition test.
Measured: 42 days after the inoculation of second needle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start6 Nov 2015
- Primary completion5 Jul 2016
- Study completion23 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza AStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects were inoculated with influenza A (H7N9) virus inactivated vaccine/split influenza vaccine or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 588 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hualan Biological Bacterin Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196661
- Sponsor's protocol ID
- 2015L00054
- Status last verified
- May 2017
- First submitted
- 19 May 2017
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study on Safety and Immunogenicity of Influenza A (H7N9) Vaccine in the Population
- ClinicalTrials.gov ID
- NCT03196661
- Acronym / sponsor ID
- 2015L00054
- Conditions
- Influenza A
- Keywords
- safety investigation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 588 participants (actual)
- Lead sponsor
- Hualan Biological Bacterin Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2015 (actual)
- Primary completion
- 5 Jul 2016 (actual)
- Study completion
- 23 Mar 2017 (actual)
- First posted
- 23 Jun 2017 (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.
Adopt the design of random, blind method and placebo to parallel control and progressive methods of groups to study and evaluate the safety and immunogenicity of influenza A (H7N9) vaccine (two types, one type with two specifications) on people of different ages. The vaccines used for testing include: influenza A (H7N9) virus inactivated vaccine/split influenza vaccine (15μg /dose), influenza A (H7N9) virus inactivated vaccine/split influenza vaccine (30μg / dose), influenza A (H7N9) virus inactivated vaccine/whole influenza vaccine (7.5μg / dose) and influenza A (H7N9) virus inactivated vaccine/ whole influenza vaccine (15μg / dose).
The study between different subgroups was carried out in an orderly and progressive manner, that is, each kind of vaccine by the dose is from low to high according to the order of age from old to young. Firstly, the study on 15μg/dose split vaccine group (aged 18 and above) and 7.5μg/dose whole-virus vaccine group (aged 18 and above) was carried out and then the study on 15μg/dose split vaccine group (aged 12-17) and 7.5μg/dose whole-virus vaccine group (aged 12-17) was conducted upon 7-day safety was confirmed after the vaccination, finally the study on 30μg/dose split vaccine group (aged 18 and above) and 15μg/dose whole-virus vaccine group (aged 18 and above) was done. By that analogy for the same conditions, the next group of test can be done after the 7-day safety of the last group of vaccine is confirmed.
Subjects and researchers didn't know the formulations of the vaccines used. The vaccine is injected into the upper arm deltoid muscle. After 30 minutes of field observation on safety, the subjects' axillary temperature shall be recorded on the Record Book prepared by the research and local and systemic reactions to injection at the 6th, 24th, 48th, and 72th hour and on the 4th, 8th, 21st and 30th day shall also be recorded. This paper collected 5 serum samples: day 0 (before the first-dose vaccination), day 4 (after the first-dose vaccination), day 21 (before the second-dose vaccination), day 25 (fourth day after the second-dose vaccination) and day 42 (21st day after the second-dose vaccination), of which, blood samples on day 0, 21 and 42 should be stored at 18℃ for antibody detection and the remaining 2 blood samples are only used for blood routine examination, routine urine test, blood biochemistry and other laboratory examinations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Subjects were inoculated with influenza A (H7N9) virus inactivated vaccine/split influenza vaccine or placebo.
| Arm | Type | Receives |
|---|---|---|
| H7N9 split influenza vaccine (15μg/dose) | Placebo comparator | Biological: Influenza A (H7N9) virus vaccineThis group was divided into three subgroups according ages of subjects, the ages of those subjects are: 3 to 11(36 subjects got inoculated test vaccines, 18 subjects got inoculated reference vaccines)，12 to 17(36 subjects got inoculated test vaccines, 12 subjects got inoculated reference vaccines)，≥18 (36 subjects got inoculated test vaccines, 12 subjects got inoculated reference vaccines). Immune procedure: 0,21st day; Physical examination: 0,4th, 21st,25th day; Antibody detection: 0,21st,42nd day. |
| H7N9 split influenza vaccine (30μg/dose) | Placebo comparator | Biological: Influenza A (H7N9) virus vaccineThis group was divided into three subgroups according ages of subjects, the ages of those subjects are: 3 to 11(36 subjects got inoculated test vaccines, 18 subjects got inoculated reference vaccines)，12 to 17(36 subjects got inoculated test vaccines, 12 subjects got inoculated reference vaccines)，≥18 (36 subjects got inoculated test vaccines, 12 subjects got inoculated reference vaccines). Immune procedure: 0,21st day; Physical examination: 0,4th, 21st,25th day; Antibody detection: 0,21st,42nd day. |
| H7N9 whole virus influenza vaccine (7.5μg/dose) | Placebo comparator | Biological: Influenza A (H7N9) virus vaccineThis group was divided into two subgroups according ages of subjects, the ages of those subjects are: 12 to 17(54 subjects got inoculated test vaccines,18 subjects got inoculated reference vaccines)，≥18 (54 subjects got inoculated test vaccines, 18 subjects got inoculated reference vaccines). Immune procedure: 0,21st day; Physical examination: 0,4th, 21st,25th day; Antibody detection: 0,21st,42nd day. |
| H7N9 whole virus influenza vaccine (15μg/dose) | Placebo comparator | Biological: Influenza A (H7N9) virus vaccineThis group was divided into two subgroups according ages of subjects, the ages of those subjects are: 12 to 17(54 subjects got inoculated test vaccines,18 subjects got inoculated reference vaccines)，≥18 (54 subjects got inoculated test vaccines, 18 subjects got inoculated reference vaccines). Immune procedure: 0,21st day; Physical examination: 0,4th, 21st,25th day; Antibody detection: 0,21st,42nd day. |
Who may qualify
- Ages
- 3 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Permanent healthy residents with normal intelligence meet the minimum age requirement. Literate and willing to provide written informed consent.
- A signed informed consent.
- Willing to comply with the rules of the clinical trial scheme. Accept the blood examination before and after immunization and cooperate follow-up visit.
Key exclusion criteria (8 listed)
- Exclusion criteria of the first vaccination A person with a history of H7N9 virus infection or suspected infection; Who is allergic to any component of trial vaccine (and past history of any allergy vaccination), especially allergic to eggs; No spleen, or the spleen isn't working; Autoimmune diseases or immunodeficiency, have been treated with immunosuppressant over the past six months; Acute attack of acute illness or chronic disease in almost 7 days; Accept blood products in three months before getting inoculated testing vaccine; Got inoculated active virus vaccine in 14 days or subtype or inactivated virus in 7 days before getting inoculated testing vaccine; Who had been infected by any acute diseases ;
- Who had fever in past 3 days (axillary temperature ≥ 38 ℃);
- Who is participating another clinical trial
- Who had allergies, convulsions, epilepsy, encephalopathy, psychosis history or family history;
- Who is suffering from thrombocytopenia or other coagulation disorder, which may result to intramuscular injection contraindication; The laboratory detection indexes are abnormal before getting inoculated testing vaccine; The females are in suckling period, pregnancy, plan of pregnant or pregnancy tests (positive).
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 |
|---|---|---|
| Influenza A (H7N9) virus vaccineTo prevent the infection of H7N9 virus. | Biological | H7N9 split influenza vaccine (15μg/dose), H7N9 split influenza vaccine (30μg/dose), H7N9 whole virus influenza vaccine (15μg/dose), H7N9 whole virus influenza vaccine (7.5μg/dose) |
Primary outcome
587 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.
Time frame: 20 days after the inoculation of first needle
Inspect the measures like pain, induration, redness, red and swollen, rash, pruritus, skin mucosa reaction, etc. All these data is collected through questionnaires.
587 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.
Time frame: 30 days after the inoculation of second needle
Inspect the measures like pain, induration, redness, red and swollen, rash, pruritus, skin mucosa reaction, etc. All these data is collected through questionnaires.
587 subjects accept the observation of systemic adverse reactions according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.
Time frame: 20 days after the inoculation of first needle
Inspect the measures like fever, headache, fatigue, weak, nausea, diarrhea, cough, allergic reaction, etc. All these data is collected through questionnaires.
587 subjects accept the observation of systemic adverse reactions according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.
Time frame: 30 days after the inoculation of second needle
Inspect the measures like fever, headache, fatigue, weak, nausea, diarrhea, cough, allergic reaction, etc. All these data is collected through questionnaires.
2 secondary outcomes
558 subjects accept the immunogenicity test according to micro-hemagglutination-inhibition test.
Time frame: 21 days after the inoculation of first needle
558 subjects accept the immunogenicity test according to micro-hemagglutination-inhibition test.
Time frame: 42 days after the inoculation of second needle
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 23 Jun 2017.
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Healthy Participants
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Influenza A (H7N9) virus vaccine in people with Influenza A, run by Hualan Biological Bacterin Co. Ltd..
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 8 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 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
587 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention. (time frame: 20 days after the inoculation of first needle). The study lists 4 primary outcomes in all. 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 23 Jun 2017.