HealthyPhase 1NCT01676675
A Phase I Clinical Trial With Whole Virus Inactivated Influenza H5N1 Vaccine in Healthy Adolescents and Adults
A Phase 1 study testing 7.5μg /0.5ml, 15.0μg /0.5ml and 30.0μg /0.5ml in people with Healthy, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial summary
Influenza is an acute respiratory infection caused by influenza virus with high incidence and serious complications even causing death. According to the announcement released by the World Health Organization (WHO), the number of global annual influenza case was 0.6 to 1.2 billion and 0.5 to 1 million people died. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Healthy
- What is being tested?
- 7.5μg /0.5ml, 15.0μg /0.5ml and 30.0μg /0.5ml
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Aug 2012to Mar 2013
- 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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Healthy subjects aged from 12 to 60 years old of normal intelligence;
- The subjects' guardians are able to understand and sign the informed consent;
- Subjects established as healthy after medical history questioning, physical examination and clinical decision;
- Subjects who can comply with the requirements of the clinical trial protocol;
- Subjects who have never received influenza H5N1 vaccine and other preventive products;
- Subjects with temperature ≤37°C on axillary setting.
Who cannot join
- Women in pregnancy / lactation or plan to be pregnant during the study;
- The subject has a history of allergy or is allergic with any Ingredient of vaccine, such as egg, ovalbumin;
- Had serious adverse reactions in previous vaccination, such as allergies, hives, difficult breath, angioneurotic edema or abdominal pain;
- Autoimmune diseases or immune deficiency;
- Had asthma, over the past two years, the condition is unstable in need of emergency treatment, hospitalization and oral or intravenous corticosteroids;
- Diabete (type I or type II) not including gestational diabete;
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- Thyroidectomy history, or treatment because of thyroid diseases in the past 12 months;
- Over the past 3 years, severe angioneurotic edema, or need treatment in the past 2 years;
- Severe hypertension and blood pressure is still more than 150/100 mmHg after drug maintenance therapy;
- coagulation abnormalities diagnosed by doctor (such as lack of coagulation factors, coagulation disorder diseases, platelet abnormality) or coagulation disorder;
- Malignancy, active or treated tumor without explicitly been cured, or the possibility of a recurrence during the study period;
- Epilepsy not including alcohol epilepsy of stop drinking in the first 3 years or the simplicity not requiring treatment in the past 3 years;
- Asplenia, functional asplenia, and any circumstances leading to asplenia or splenectomy;
- Guillain-Barre syndrome;
- Had immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray to treat allergic rhinitis and corticosteroid treatment of the acute uncomplicated dermatitis) within the past six months;
- Received immune globulin in three months before study;
- Received other experimental drugs in 30 days before study;
- Received live attenuated vaccine in 30 days before study;
- Receiving subunit or inactivated vaccines in 14days before study, such as pneumococcal vaccine or allergy treatment;
- In prevention or treatment of the anti-TB (antituberculosis) now;
- Had fever (axillary temperature ≥ 38.0℃) 3 days before vaccination or had any acute illness in the past five days requiring systemic antibiotics or antiviral therapy);
- The subject is unable to comply with the study requirements because of psychology, or had mental illness or dual-stage affective psychosis not well controlled within the past two years or had psychology in medication and suicidal tendency in the past five years;
- According to the researcher, contrary to the study protocol or effect signed informed consent due to a variety of medical, psychological, social conditions, occupational factors or other conditions.
- Had any vaccination-related Grade 3 or more adverse reactions in 72 hours after first vaccination;
- Any situation meets the exclusion criteria stated in the exclusion criteria for first dose;
- Had serious adverse reactions caused by the study vaccination.
- Acute infection;
- Any condition the investigator believed may affect the evaluation of the vaccine.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, 210009
About this study
Official title: A Single Center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Clinical Trial for Safety and Preliminary Immunogenicity of a Whole Virus Inactivated Influenza H5N1 Vaccine in Healthy Adolescents and Adults, on Day 0 and 21 Intramuscularly
Influenza is an acute respiratory infection caused by influenza virus with high incidence and serious complications even causing death. According to the announcement released by the World Health Organization (WHO), the number of global annual influenza case was 0.6 to 1.2 billion and 0.5 to 1 million people died. The emergence of a new subtype of influenza virus may cause an influenza pandemic with occurence once every 10 to 50 years which cause serious adverse consequences for human health and social welfare worldwide.
From 1997 to 2003，the H5N1 virus infection has increased highly and gradually spreaded to Europe, Africa and other countries and regions. High mortality caused by H5N1 virus has attracted the WHO and national government great attention. So it is meaningful to develop vaccine to provide effective antibody to reduce the number of infections.
The objective of this study is to evaluate the safety and preliminary immunogenicity of a whole virus inactivated influenza H5N1 vaccine.
- Conditions
- Healthy
- Being tested
- 7.5μg /0.5ml, 15.0μg /0.5ml, 30.0μg /0.5ml, 0/0.5ml placebo
- Keywords
- whole virus, inactivated, influenza, H5N1 vaccine, safety, immunogenicity
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7.5μg /0.5mlBiological
whole virus inactivated influenza H5N1 vaccine of 7.5μg /0.5ml, two doses, 21 days interval
15.0μg /0.5mlBiological
whole virus inactivated influenza H5N1 vaccine of 15.0μg /0.5ml, two doses, 21 days interval
30.0μg /0.5mlBiological
whole virus inactivated influenza H5N1 vaccine of 30.0μg /0.5ml, two doses, 21 days interval
0/0.5ml placeboBiological
0/0.5ml placebo, two doses, 21 days interval
| Study group | Role | What they receive |
|---|---|---|
| 7.5μg/0.5ml in subjects(12-17 years old) | Experimental | whole virus inactivated influenza H5N1 vaccine of 7.5μg /0.5ml in 30 adolescents aged 12-17 years old on day 0, 21 Receives: Biological: 7.5μg /0.5ml |
| 15μg/0.5ml in subjects(12-17 years old) | Experimental | whole virus inactivated influenza H5N1 vaccine of 15.0μg /0.5ml in 30 adolescents aged 12-17 years old on day0,21 Receives: Biological: 15.0μg /0.5ml |
| 30μg/0.5ml in subjects(12-17 years old) | Experimental | whole virus inactivated influenza H5N1 vaccine of 30.0μg /0.5ml in 30 adolescents aged 12-17 years old on day0,21 Receives: Biological: 30.0μg /0.5ml |
| 7.5μg/0.5ml in subjects(18-60 years old) | Experimental | whole virus inactivated influenza H5N1 vaccine of 7.5μg /0.5ml in 30 adults aged 18-60 years old on day 0, 21 Receives: Biological: 7.5μg /0.5ml |
| 15μg/0.5ml in subjects(18-60 years old) | Experimental | whole virus inactivated influenza H5N1 vaccine of 15.0μg /0.5ml in 30 adults aged 18-60 years old on day 0, 21 Receives: Biological: 15.0μg /0.5ml |
| 30μg/0.5ml in subjects(18-60 years old) | Experimental | whole virus inactivated influenza H5N1 vaccine of 30.0μg /0.5ml in 30 adults aged 18-60 years old on day 0, 21 Receives: Biological: 30.0μg /0.5ml |
| 0/0.5ml in adolescents (12-17 years old) | Placebo comparator | 0/0.5ml placebo in 30 adolescents aged 12-17 years old on day 0, 21 Receives: Biological: 0/0.5ml placebo |
| 0/0.5ml in adults(18-60 years old) | Placebo comparator | 0/0.5ml placebo in 30 adults aged 18-60 years old on day 0, 21 Receives: Biological: 0/0.5ml placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the safety of whole virus inactivated influenza H5N1 vaccine in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
Frequency of systemic and local adverse reactions within 21 days after the first doses of whole virus inactivated influenza H5N1 vaccine in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
Measured: 21 days after the first dose
the safety of whole virus inactivated influenza H5N1 vaccine in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
Frequency of systemic and local adverse reactions within 21 days after the second doses of whole virus inactivated influenza H5N1 vaccine in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
Measured: 21 days after the second dose
the immunogenicity of the vaccine after first dose
the seroconversion rate and GMFI of antibodies on day 21 after first dose with different formulation vaccines in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
Measured: on day 21±3 days
the immunogenicity of the vaccine after second dose
the seroconversion rate and GMFI of antibodies on day 21 after second dose with different formulation vaccines in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
Measured: on day 42±7 days
the immunogenicity of the vaccine after whole immunization
the seroconversion rate and GMFI of antibodies 3 months after the second dose with different formulation vaccines in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
Measured: 3 months after second dose (±14 days)
Secondary outcomes (2)
abnormal change of hematological examination and the function of liver and kidney after first dose
abnormal change of hematological examination and the function of liver and kidney 3 days after first dose with different formulation vaccines in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
Measured: 3 days after first dose
abnormal change of hematological examination and the function of liver and kidney after second dose
abnormal change of hematological examination and the function of liver and kidney 3 days after second dose with different formulation vaccines in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
Measured: 3 days after second dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Collaborators
- Wuhan Institute of Biological Products Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676675
- Sponsor's protocol ID
- JSVCT011
- Status last verified
- Mar 2013
- First submitted
- 29 Aug 2012
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
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 Single Center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Clinical Trial for Safety and Preliminary Immunogenicity of a Whole Virus Inactivated Influenza H5N1 Vaccine in Healthy Adolescents and Adults, on Day 0 and 21 Intramuscularly
- ClinicalTrials.gov ID
- NCT01676675
- Acronym / sponsor ID
- JSVCT011
- Conditions
- Healthy
- Keywords
- whole virus, inactivated, influenza, H5N1 vaccine, safety, immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Wuhan Institute of Biological Products Co., Ltd
- Study start
- Aug 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 31 Aug 2012 (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.
Influenza is an acute respiratory infection caused by influenza virus with high incidence and serious complications even causing death. According to the announcement released by the World Health Organization (WHO), the number of global annual influenza case was 0.6 to 1.2 billion and 0.5 to 1 million people died. The emergence of a new subtype of influenza virus may cause an influenza pandemic with occurence once every 10 to 50 years which cause serious adverse consequences for human health and social welfare worldwide.
From 1997 to 2003，the H5N1 virus infection has increased highly and gradually spreaded to Europe, Africa and other countries and regions. High mortality caused by H5N1 virus has attracted the WHO and national government great attention. So it is meaningful to develop vaccine to provide effective antibody to reduce the number of infections.
The objective of this study is to evaluate the safety and preliminary immunogenicity of a whole virus inactivated influenza H5N1 vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 7.5μg/0.5ml in subjects(12-17 years old) | Experimental | Biological: 7.5μg /0.5mlwhole virus inactivated influenza H5N1 vaccine of 7.5μg /0.5ml in 30 adolescents aged 12-17 years old on day 0, 21 |
| 15μg/0.5ml in subjects(12-17 years old) | Experimental | Biological: 15.0μg /0.5mlwhole virus inactivated influenza H5N1 vaccine of 15.0μg /0.5ml in 30 adolescents aged 12-17 years old on day0,21 |
| 30μg/0.5ml in subjects(12-17 years old) | Experimental | Biological: 30.0μg /0.5mlwhole virus inactivated influenza H5N1 vaccine of 30.0μg /0.5ml in 30 adolescents aged 12-17 years old on day0,21 |
| 7.5μg/0.5ml in subjects(18-60 years old) | Experimental | Biological: 7.5μg /0.5mlwhole virus inactivated influenza H5N1 vaccine of 7.5μg /0.5ml in 30 adults aged 18-60 years old on day 0, 21 |
| 15μg/0.5ml in subjects(18-60 years old) | Experimental | Biological: 15.0μg /0.5mlwhole virus inactivated influenza H5N1 vaccine of 15.0μg /0.5ml in 30 adults aged 18-60 years old on day 0, 21 |
| 30μg/0.5ml in subjects(18-60 years old) | Experimental | Biological: 30.0μg /0.5mlwhole virus inactivated influenza H5N1 vaccine of 30.0μg /0.5ml in 30 adults aged 18-60 years old on day 0, 21 |
| 0/0.5ml in adolescents (12-17 years old) | Placebo comparator | Biological: 0/0.5ml placebo0/0.5ml placebo in 30 adolescents aged 12-17 years old on day 0, 21 |
| 0/0.5ml in adults(18-60 years old) | Placebo comparator | Biological: 0/0.5ml placebo0/0.5ml placebo in 30 adults aged 18-60 years old on day 0, 21 |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Healthy subjects aged from 12 to 60 years old of normal intelligence;
- The subjects' guardians are able to understand and sign the informed consent;
- Subjects established as healthy after medical history questioning, physical examination and clinical decision;
- Subjects who can comply with the requirements of the clinical trial protocol;
- Subjects who have never received influenza H5N1 vaccine and other preventive products;
Key exclusion criteria (28 listed)
- Women in pregnancy / lactation or plan to be pregnant during the study;
- The subject has a history of allergy or is allergic with any Ingredient of vaccine, such as egg, ovalbumin;
- Had serious adverse reactions in previous vaccination, such as allergies, hives, difficult breath, angioneurotic edema or abdominal pain;
- Autoimmune diseases or immune deficiency;
- Had asthma, over the past two years, the condition is unstable in need of emergency treatment, hospitalization and oral or intravenous corticosteroids;
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 |
|---|---|---|
| 7.5μg /0.5mlwhole virus inactivated influenza H5N1 vaccine of 7.5μg /0.5ml, two doses, 21 days interval | Biological | 7.5μg/0.5ml in subjects(12-17 years old), 7.5μg/0.5ml in subjects(18-60 years old) |
| 15.0μg /0.5mlwhole virus inactivated influenza H5N1 vaccine of 15.0μg /0.5ml, two doses, 21 days interval | Biological | 15μg/0.5ml in subjects(12-17 years old), 15μg/0.5ml in subjects(18-60 years old) |
| 30.0μg /0.5mlwhole virus inactivated influenza H5N1 vaccine of 30.0μg /0.5ml, two doses, 21 days interval | Biological | 30μg/0.5ml in subjects(12-17 years old), 30μg/0.5ml in subjects(18-60 years old) |
| 0/0.5ml placebo0/0.5ml placebo, two doses, 21 days interval | Biological | 0/0.5ml in adolescents (12-17 years old), 0/0.5ml in adults(18-60 years old) |
Primary outcome
the safety of whole virus inactivated influenza H5N1 vaccine in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
Time frame: 21 days after the first dose
Frequency of systemic and local adverse reactions within 21 days after the first doses of whole virus inactivated influenza H5N1 vaccine in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
the safety of whole virus inactivated influenza H5N1 vaccine in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
Time frame: 21 days after the second dose
Frequency of systemic and local adverse reactions within 21 days after the second doses of whole virus inactivated influenza H5N1 vaccine in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
the immunogenicity of the vaccine after first dose
Time frame: on day 21±3 days
the seroconversion rate and GMFI of antibodies on day 21 after first dose with different formulation vaccines in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
the immunogenicity of the vaccine after second dose
Time frame: on day 42±7 days
the seroconversion rate and GMFI of antibodies on day 21 after second dose with different formulation vaccines in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
the immunogenicity of the vaccine after whole immunization
Time frame: 3 months after second dose (±14 days)
the seroconversion rate and GMFI of antibodies 3 months after the second dose with different formulation vaccines in healthy adolescents aged from 12-17 years and adults aged from 18-60 years
2 secondary outcomes
abnormal change of hematological examination and the function of liver and kidney after first dose
Time frame: 3 days after first dose
abnormal change of hematological examination and the function of liver and kidney after second dose
Time frame: 3 days after second dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2013.
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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 1 study testing 7.5μg /0.5ml, 15.0μg /0.5ml and 30.0μg /0.5ml in people with Healthy, run by Jiangsu Province Centers for Disease Control and Prevention 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 6 inclusion and 28 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: withdrawn, 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 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 was withdrawn before enrolling participants, so there are no results.
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?
the safety of whole virus inactivated influenza H5N1 vaccine in healthy adolescents aged from 12-17 years and adults aged from 18-60 years (time frame: 21 days after the first dose). The study lists 5 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 15 Mar 2013.