Human InfluenzaNCT01568788
Post-marketing Clinical Observation of an Inactivated Influenza Split Vaccine
A study testing Inactivated Influenza Vaccine, Inactivated Influenza Vaccine of Pasteur and Inactivated Influenza Vaccine of GSK in people with Human Influenza, run by Hualan Biological Engineering, Inc. at 1 site in China.
Trial summary
Phase III clinical trial was carried out in Jintan city, Jiangsu Province, China in May, 2006. Trial results showed that the vaccine had proved safety and immunogenicity. Influenza vaccine of Hualanbio has obtained production permission and marketing authorization in May, 2008. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Influenza
- What is being tested?
- Inactivated Influenza Vaccine, Inactivated Influenza Vaccine of Pasteur and Inactivated Influenza Vaccine of GSK
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Dec 2008to Mar 2009
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy male or female age 3 and older, volunteers or their guardians are able to understand and sign the informed consent;
- Healthy male or female 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 vaccination within the past 6 months and vaccination with other product within the latest 1 week;
- Axillary temperature <37.1℃.
Who cannot join
- Subject that was allergic to eggs and any component of the vaccine, or has history of other allergy;
- Fever, acute disease or acute onset of chronic disease and influenza;
- Guillain-Barre Syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-marketing Clinical Observation of Hualan's Inactivated Influenza Vaccine: A Single Center, Parallelled, Controlled, Randomised Clinical Trial
Phase III clinical trial was carried out in Jintan city, Jiangsu Province, China in May, 2006. Trial results showed that the vaccine had proved safety and immunogenicity. Influenza vaccine of Hualanbio has obtained production permission and marketing authorization in May, 2008.
In order to further investigate the safety and immunogenicity of the vaccine in the market, The clinical observation was planned to be conducted in Mianyang city (Yanting County), Sichuan Province, China.
Read the detailed description
Dosage and administration route in this clinical trial:
Subjects age 3 years or older was vaccinated following a single 0.5ml dose immunization regime.
The preferred site of injection was the at the skin near outboard deltoid muscle of the upper arm.
The administration route is after the sanitization with 75% alcohol, intramuscularly inject the test vaccine or the control vaccines when the skin was slightly dried for those subjects complied with the inclusion requirements.
Safety indicators:
- Post-vaccination local and systemic adverse reaction levels, together with the soliciting adverse reaction within 30 minutes ;
- Post-vaccination local and systemic adverse reaction levels, together with the soliciting adverse reactions through 6 hours to the 29th day ;
- Summarize the adverse events/severe adverse events and the incidence levels from the inclusion of the subjects to the completion of the clinical trial.
Immunogenicity indicators:
Evaluate the Post-vaccination immunogenicity of the test and the control influenza vaccines in persons age 3 years and older by its HI antibody level on Day 28.
Take 1:10 serum dilution as the minimum dilutability. The seroconversion in this trial was defined as the post-vaccination HI antibody titer ≥ 1:40 when the HI antibody < 1:10 before the vaccination or the post-vaccination HI antibody titer quadruply increased when HI antibody ≥ 1:10 before the vaccination.
The Immunogenicity criteria set for this clinical trial is the seroconversion shall be > 40% after 14 days of the vaccination.
- Conditions
- Human Influenza
- Being tested
- Inactivated Influenza Vaccine, Inactivated Influenza Vaccine of Pasteur, Inactivated Influenza Vaccine of GSK
- Keywords
- Respiratory Tract Infections; Orthomyxoviridae Infections
- Medical subject headings
- Influenza, Human, Respiratory Tract Infections, Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated Influenza VaccineBiological
Also called Hualan Biologicals
200 subjects were randomly assigned (60 children, 100 adults and 40 elders) to receive Inactivated Influenza Vaccine (Split virion) of Hualan Biologicals, 15ug HA/strain/0.5ml/syringe, one dose regime
Inactivated Influenza Vaccine of PasteurBiological
Also called VAXIGRIP
200 subjects (60 children, 100 adults and 40 elders) were randomly assigned to receive the Inactivated Influenza Vaccine of Sanofi Pasteur, 15ug HA/strain/0.5 ml/syringe, one dose regime,
Inactivated Influenza Vaccine of GSKBiological
Also called Fluarix
200 subjects (60 children, 100 adults and 40 elders) were randomly assigned to receive Inactivated Influenza Vaccine (Split virion) of GSK, 15ug HA/strain/0.5ml/syringe, one dose regime
| Study group | Role | What they receive |
|---|---|---|
| Inactivated Influenza Vaccine | Experimental | 15μg HA/strain/0.5ml/syringe, Hualan Biologicals Receives: Biological: Inactivated Influenza Vaccine |
| Inactivated Influenza Vaccine of Pasteur | Active comparator | 15ug HA/strain/0.5ml/syringe, Sanofi Pasteur Receives: Biological: Inactivated Influenza Vaccine of Pasteur |
| Inactivated Influenza Vaccine of GSK | Active comparator | 15ug HA/strain/0.5ml/syringe, GSK Receives: Biological: Inactivated Influenza Vaccine of GSK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse reactions as a measure of safety study
Local reactions, systemic reactions, severity degree and AEFI correlation
Measured: 28 days after the vaccination
Secondary outcomes (1)
Observation of the immunological effect
HI antibody seroconversion ratios
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 posted2 Apr 2012 (estimated)
- Study startDec 2008
- Primary completionJan 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hualan Biological Engineering, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pei-ru Zhang, Principal investigator, Immune Planning Institute of Mianyang Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568788
- Sponsor's protocol ID
- Hualanbio-influenza-IV-002
- Other IDs
- Hualanbio-003
- Status last verified
- Apr 2012
- First submitted
- 28 Mar 2012
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang PR, Zhu XP, Zhou LJ, Liu YQ, Fan Y, Chen G, Chen Z, Liu Y, Sun HY, Wu JL. [Safety and immunological effect of domestic split influenza virus vaccine]. Zhonghua Yu Fang Yi Xue Za Zhi. 2009 Jul;43(7):615-8. Chinese.
PubMed 19954075
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Clinical Observation of Hualan's Inactivated Influenza Vaccine: A Single Center, Parallelled, Controlled, Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT01568788
- Acronym / sponsor ID
- Hualanbio-influenza-IV-002
- Conditions
- Human Influenza
- Keywords
- Respiratory Tract Infections; Orthomyxoviridae Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Hualan Biological Engineering, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 2 Apr 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.
Phase III clinical trial was carried out in Jintan city, Jiangsu Province, China in May, 2006. Trial results showed that the vaccine had proved safety and immunogenicity. Influenza vaccine of Hualanbio has obtained production permission and marketing authorization in May, 2008.
In order to further investigate the safety and immunogenicity of the vaccine in the market, The clinical observation was planned to be conducted in Mianyang city (Yanting County), Sichuan Province, China.
Detailed description
Dosage and administration route in this clinical trial:
Subjects age 3 years or older was vaccinated following a single 0.5ml dose immunization regime.
The preferred site of injection was the at the skin near outboard deltoid muscle of the upper arm.
The administration route is after the sanitization with 75% alcohol, intramuscularly inject the test vaccine or the control vaccines when the skin was slightly dried for those subjects complied with the inclusion requirements.
Safety indicators:
- Post-vaccination local and systemic adverse reaction levels, together with the soliciting adverse reaction within 30 minutes ;
- Post-vaccination local and systemic adverse reaction levels, together with the soliciting adverse reactions through 6 hours to the 29th day ;
- Summarize the adverse events/severe adverse events and the incidence levels from the inclusion of the subjects to the completion of the clinical trial.
Immunogenicity indicators:
Evaluate the Post-vaccination immunogenicity of the test and the control influenza vaccines in persons age 3 years and older by its HI antibody level on Day 28.
Take 1:10 serum dilution as the minimum dilutability. The seroconversion in this trial was defined as the post-vaccination HI antibody titer ≥ 1:40 when the HI antibody < 1:10 before the vaccination or the post-vaccination HI antibody titer quadruply increased when HI antibody ≥ 1:10 before the vaccination.
The Immunogenicity criteria set for this clinical trial is the seroconversion shall be > 40% after 14 days of the vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inactivated Influenza Vaccine | Experimental | Biological: Inactivated Influenza Vaccine15μg HA/strain/0.5ml/syringe, Hualan Biologicals |
| Inactivated Influenza Vaccine of Pasteur | Active comparator | Biological: Inactivated Influenza Vaccine of Pasteur15ug HA/strain/0.5ml/syringe, Sanofi Pasteur |
| Inactivated Influenza Vaccine of GSK | Active comparator | Biological: Inactivated Influenza Vaccine of GSK15ug HA/strain/0.5ml/syringe, GSK |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male or female age 3 and older, volunteers or their guardians are able to understand and sign the informed consent;
- Healthy male or female 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 vaccination within the past 6 months and vaccination with other product within the latest 1 week;
- Axillary temperature <37.1℃.
Key exclusion criteria (3 listed)
- Subject that was allergic to eggs and any component of the vaccine, or has history of other allergy;
- Fever, acute disease or acute onset of chronic disease and influenza;
- Guillain-Barre Syndrome
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 |
|---|---|---|
| Inactivated Influenza VaccineAlso: Hualan Biologicals200 subjects were randomly assigned (60 children, 100 adults and 40 elders) to receive Inactivated Influenza Vaccine (Split virion) of Hualan Biologicals, 15ug HA/strain/0.5ml/syringe, one dose regime | Biological | Inactivated Influenza Vaccine |
| Inactivated Influenza Vaccine of PasteurAlso: VAXIGRIP200 subjects (60 children, 100 adults and 40 elders) were randomly assigned to receive the Inactivated Influenza Vaccine of Sanofi Pasteur, 15ug HA/strain/0.5 ml/syringe, one dose regime, | Biological | Inactivated Influenza Vaccine of Pasteur |
| Inactivated Influenza Vaccine of GSKAlso: Fluarix200 subjects (60 children, 100 adults and 40 elders) were randomly assigned to receive Inactivated Influenza Vaccine (Split virion) of GSK, 15ug HA/strain/0.5ml/syringe, one dose regime | Biological | Inactivated Influenza Vaccine of GSK |
Primary outcome
Number of subjects with adverse reactions as a measure of safety study
Time frame: 28 days after the vaccination
Local reactions, systemic reactions, severity degree and AEFI correlation
1 secondary outcome
Observation of the immunological effect
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 20 Jun 2012.
- Results publication: PubMed 19954075Zhang PR, Zhu XP, Zhou LJ, Liu YQ, Fan Y, Chen G, Chen Z, Liu Y, Sun HY, Wu JL. [Safety and immunological effect of domestic split influenza virus vaccine]. Zhonghua Yu Fang Yi Xue Za Zhi. 2009 Jul;43(7):615-8. Chinese.
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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.
Pei-ru Zhang principal investigator
Immune Planning Institute of Mianyang Center for Disease Prevention and Control
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inactivated Influenza Vaccine, Inactivated Influenza Vaccine of Pasteur and Inactivated Influenza Vaccine of GSK in people with Human 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 5 inclusion and 3 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 20 Jun 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.
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 with adverse reactions 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?
On the ClinicalTrials.gov record for NCT01568788, which also lists 1 linked publication.
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 20 Jun 2012.