InfluenzaPhase 3NCT01554813
Clinical Trial of Inactivated Influenza Vaccine (0.5ml Formulation)
A Phase 3 study testing Influenza split vaccine of 15 μg HA and Influenza split vaccine in people with Influenza, run by Hualan Biological Engineering, Inc. at 1 site in China.
Trial summary
The clinical trial was conducted in Jintan City of Jiangsu Province, China in May, 2006. The purpose of the clinical trial was to evaluate the safety and immunogenicity against Hualan's Influenza Vaccine (Split Virion), Inactivated (0.5ml) administered on age 6 months and old population. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza split vaccine of 15 μg HA and Influenza split vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- May 2006to Oct 2006
- Phase
- Phase 3
- 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 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Inclusion criteria for the primary vaccination on subjects over 3 years old and subjects 6 months～3 years old
- Healthy male and female 6 months or over, subject (or their guardians) are able to understand and sign informed consent
- Healthy person by inquiring illness history, physical examination and clinical judgment and who complies with vaccination of this product
- Be able to comply with the requirement of clinical trial protocol
- Have no history of influenza vaccination within the past 6 months and vaccination with other product within the latest 1 week;
- Axillary temperature<37.1℃.
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- Inclusion criteria for the boost vaccination on subjects age 6 months～3 years
- Have no history of vaccination with other preventive product within the latest 1 week;
- Axillary temperature<37.1℃.
Who cannot join
- Exclusion criteria for the primary vaccination on subjects over 3 years old and subjects age 6 months～3 years
- Serious diseases, such as: tumor, autoimmunity disease, progressive atherosclerotic disease or diabetes with complication, COPD needing oxygen uptake treatment, acute or progressive liver or kidney disease, CHF, etc.
- Subjects who are allergic to any component of test vaccine (history of vaccination allergy), especially allergic to eggs
- History of symptoms or signs in neurological system
- Known or suspected (high risk of onset) damaged or abnormal immunologic function need receiving immunosuppressant or immunopotentiator treatment; history of receiving immunoglobulin or blood product or plasma extractive outside the gastrointestinal tract within the past 3 months; and HIV infection or relevant diseases
- Haemorrhage physique or extension of haemorrhage time
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- History of influenza or at least once influenza vaccination within the past 6 months
- History of receiving other vaccination or injection of immunoglobulin and any test drug within the past 1 week
- History of any acute disease and infection needing antibiotics or antiviral treatment in whole body within the past 7 days
- History of fever within the past three days (axillary temperature≥37.1℃)
- Participating in another clinical trial
- History of allergy, eclampsia, epilepsy, encephalopathy and mental disease or family disease;
- Thrombopenia or other coagulopathy that may cause contraindication of intramuscular injection
- Serious chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease, and GBS)
- Known or suspected diseases at the same time, including: respiratory system disease, acute infection or active stage of chronic disease, HIV infection of infants or mothers, CVD, serious hypertension, during the treatment of tumor and skin disease
- Any condition may affect trial assessment in judgment of investigators.
- Exclusion criteria for the boost vaccination on subjects age 6 months～3 years
- History of receiving other vaccination or injection of immunoglobulin and any test drug within the past 1 week
- History of any acute disease and infection needing antibiotics or antiviral treatment in whole body within the past 7 days
- History of fever within the past three days (axillary temperature≥37.1℃).
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Disease Prevention and Control
Nanjing, Jiangsu, 210000
About this study
Official title: A Single - Blind, Randomized, - Controlled Clinical Trial With Inactivated Influenza Vaccine (Split Virion) (0.5ml Formulation)
The clinical trial was conducted in Jintan City of Jiangsu Province, China in May, 2006. The purpose of the clinical trial was to evaluate the safety and immunogenicity against Hualan's Influenza Vaccine (Split Virion), Inactivated (0.5ml) administered on age 6 months and old population.
Read the detailed description
The clinical trial was designed randomized and blind. Participants included up to 900 persons. The clinical trial had two stages: the first stage selected 60 subjects to be administered test vaccine for preliminary safety study; 840 subjects were selected at the second stage for the observation of the safety and immunogenicity against the test vaccine administered on large population on the basis of the first stage. There were 560 subjects and 280 subjects in the test group and control group respectively.
Venous blood from subjects was collected before immunization and 4 weeks after the whole immunization for the analysis of the immunogenicity. The information about adverse reactions/time was reported to the SFDA every month during the trial under the status of blinding. Unblinding was conducted after the subject follow-up and observation.
- Conditions
- Influenza
- Being tested
- Influenza split vaccine of 15 μg HA, Influenza split vaccine
- Keywords
- Influenza Vaccine, Vaccination,
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza split vaccine of 15 μg HABiological
Also called Hualan Bio
60 subjects were assigned (20 infants, 20 children and 20 adults) to receive influenza vaccine (split virion), inactivated, 0.5ml, one dose regime
Influenza split vaccine of 15 μg HABiological
Also called Hualan Bio
558 subjects were assigned to receive influenza split vaccine, 0.5ml, one dose regime
Influenza split vaccineBiological
Also called Shenzhen Aventis Pasteur
280 subjects were assigned to receive influenza split vaccine, 0.5ml, one dose regime
| Study group | Role | What they receive |
|---|---|---|
| Influenza split vaccine of 15μg HA | Experimental | 15μg HA/strain/0.5ml/vial Receives: Biological: Influenza split vaccine of 15 μg HA |
| Influenza split vaccine of 15 μg HA | Experimental | 15μg HA/strain/0.5ml/syringe Receives: Biological: Influenza split vaccine of 15 μg HA |
| Influenza split vaccine | Active comparator | 15μg HA/strain/0.5ml/syringe Receives: Biological: Influenza split vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety study
Include ADR, adverse event and severe adverse event.
Measured: 28 days after the vaccination
Secondary outcomes (1)
Observation of immunogenicity
The rate of seroconversion, the rate of seroprotection, the GMT, and the antibody increasing folds of the subjects after administration with the vaccine.
Measured: 28 days after the immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startMay 2006
- Primary completionJul 2006
- Study completionOct 2006
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.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hualan Biological Engineering, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Feng-cai Zhu, M.D., Study director, Jiangsu Provicial Center for Disease Provention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554813
- Sponsor's protocol ID
- Hualanbio-influenza III-001
- Other IDs
- Hualanbio-phase III-001
- Status last verified
- Mar 2012
- First submitted
- 12 Mar 2012
- Last updated
- 6 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single - Blind, Randomized, - Controlled Clinical Trial With Inactivated Influenza Vaccine (Split Virion) (0.5ml Formulation)
- ClinicalTrials.gov ID
- NCT01554813
- Acronym / sponsor ID
- Hualanbio-influenza III-001
- Conditions
- Influenza
- Keywords
- Influenza Vaccine, Vaccination,
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Hualan Biological Engineering, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jul 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 15 Mar 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.
The clinical trial was conducted in Jintan City of Jiangsu Province, China in May, 2006. The purpose of the clinical trial was to evaluate the safety and immunogenicity against Hualan's Influenza Vaccine (Split Virion), Inactivated (0.5ml) administered on age 6 months and old population.
Detailed description
The clinical trial was designed randomized and blind. Participants included up to 900 persons. The clinical trial had two stages: the first stage selected 60 subjects to be administered test vaccine for preliminary safety study; 840 subjects were selected at the second stage for the observation of the safety and immunogenicity against the test vaccine administered on large population on the basis of the first stage. There were 560 subjects and 280 subjects in the test group and control group respectively.
Venous blood from subjects was collected before immunization and 4 weeks after the whole immunization for the analysis of the immunogenicity. The information about adverse reactions/time was reported to the SFDA every month during the trial under the status of blinding. Unblinding was conducted after the subject follow-up and observation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Influenza split vaccine of 15μg HA | Experimental | Biological: Influenza split vaccine of 15 μg HA15μg HA/strain/0.5ml/vial |
| Influenza split vaccine of 15 μg HA | Experimental | Biological: Influenza split vaccine of 15 μg HA15μg HA/strain/0.5ml/syringe |
| Influenza split vaccine | Active comparator | Biological: Influenza split vaccine15μg HA/strain/0.5ml/syringe |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Inclusion criteria for the primary vaccination on subjects over 3 years old and subjects 6 months～3 years old
- Inclusion criteria for the boost vaccination on subjects age 6 months～3 years
Key exclusion criteria (20 listed)
- Exclusion criteria for the primary vaccination on subjects over 3 years old and subjects age 6 months～3 years
- Exclusion criteria for the boost vaccination on subjects age 6 months～3 years
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 split vaccine of 15 μg HAAlso: Hualan Bio60 subjects were assigned (20 infants, 20 children and 20 adults) to receive influenza vaccine (split virion), inactivated, 0.5ml, one dose regime | Biological | Influenza split vaccine of 15 μg HA, Influenza split vaccine of 15μg HA |
| Influenza split vaccine of 15 μg HAAlso: Hualan Bio558 subjects were assigned to receive influenza split vaccine, 0.5ml, one dose regime | Biological | Influenza split vaccine of 15 μg HA, Influenza split vaccine of 15μg HA |
| Influenza split vaccineAlso: Shenzhen Aventis Pasteur280 subjects were assigned to receive influenza split vaccine, 0.5ml, one dose regime | Biological | Influenza split vaccine |
Primary outcome
Number of participants with adverse events as a measure of safety study
Time frame: 28 days after the vaccination
Include ADR, adverse event and severe adverse event.
1 secondary outcome
Observation of immunogenicity
Time frame: 28 days after the immunization
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 6 Sep 2012.
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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.
Feng-cai Zhu, M.D. study director
Jiangsu Provicial Center for Disease Provention and Control
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Influenza split vaccine of 15 μg HA and Influenza split vaccine in people with Influenza, run by Hualan Biological Engineering, Inc. 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 9 inclusion and 20 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 6 Sep 2012. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 participants with adverse events as a measure of safety study (time frame: 28 days after the vaccination). 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 6 Sep 2012.