InfluenzaPhase 4NCT00556062
Phase IV Clinical Trial of an Influenza Split Vaccine Anflu
A Phase 4 study testing seasonal split influenza vaccine in people with Influenza, run by Sinovac Biotech Co., Ltd.
Trial summary
To evaluate the safety and immunogenicity of the three consecutive lots of an seasonal split influenza vaccine Anflu in adults, a randomized, double-blind and controlled clinical trial was conducted in 560 subjects in Tianjin City of China. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- seasonal split influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 566 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Nov 2007
- Phase
- Phase 4
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18-60 years old
- Be able to show legal identity card for the sake of recruitment Without vaccination history of seasonal split influenza vaccine in the recent 3 years
- Not participate in any other clinical trials during the study
- Not receive any immunosuppressive agents during and one month prior to the study
- Be able to understand and sign the informed consent.
Who cannot join
- Woman： Who breast-feeding or planning to become pregnant during the study
- Any history of allergic reactions; was allergic to any component of the vaccine, such as eggs or ovalbumin
- Any history of severe adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Autoimmune disease or immunodeficiency
- Acute episode of chronic diseases or conditions, including chronic hepatitis, hypertension, diabetes mellitus and cardiovascular diseases
- Guillain-Barre Syndrome
Show all 11Show fewer
- Women subjects with positive urinary pregnancy test
- Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
- Axillary temperature >37.0 centigrade at the time of dosing
- Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.
About this study
Official title: The Clinical Trial for Three Consecutive Lots of Influenza Split Vaccine Anflu by Randomized, Double-Blind and Controlled Design
To evaluate the safety and immunogenicity of the three consecutive lots of an seasonal split influenza vaccine Anflu in adults, a randomized, double-blind and controlled clinical trial was conducted in 560 subjects in Tianjin City of China.
- Conditions
- Influenza
- Being tested
- seasonal split influenza vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
seasonal split influenza vaccineBiological
0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
seasonal split influenza vaccineBiological
0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
seasonal split influenza vaccineBiological
0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
seasonal split influenza vaccineBiological
0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
| Study group | Role | What they receive |
|---|---|---|
| 1: Lot 1 | Experimental | Not described Receives: Biological: seasonal split influenza vaccine |
| 2: Lot 2 | Experimental | Not described Receives: Biological: seasonal split influenza vaccine |
| 3: Lot 3 | Experimental | Not described Receives: Biological: seasonal split influenza vaccine |
| 4: control vaccine | Active comparator | Not described Receives: Biological: seasonal split influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemagglutination-inhibition (HI) antibody titer of influenza A H1N1, influenza A H3N2 and influenza B
Measured: 0, 21 days
Secondary outcomes (1)
local and systematic adverse reactions after vaccination
Measured: within 3 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startSep 2007
- Study completionNov 2007
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.
- More trials run by Sinovac Biotech Co., LtdThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 566 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Zhilun Zhang, Principal investigator, Tianjin centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556062
- Sponsor's protocol ID
- PRO-INF-4005
- Status last verified
- Nov 2007
- First submitted
- 8 Nov 2007
- Last updated
- 9 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Trial for Three Consecutive Lots of Influenza Split Vaccine Anflu by Randomized, Double-Blind and Controlled Design
- ClinicalTrials.gov ID
- NCT00556062
- Acronym / sponsor ID
- PRO-INF-4005
- Conditions
- Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 566 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Study completion
- Nov 2007 (actual)
- First posted
- 9 Nov 2007 (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.
To evaluate the safety and immunogenicity of the three consecutive lots of an seasonal split influenza vaccine Anflu in adults, a randomized, double-blind and controlled clinical trial was conducted in 560 subjects in Tianjin City of China.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1: Lot 1 | Experimental | Biological: seasonal split influenza vaccine |
| 2: Lot 2 | Experimental | Biological: seasonal split influenza vaccine |
| 3: Lot 3 | Experimental | Biological: seasonal split influenza vaccine |
| 4: control vaccine | Active comparator | Biological: seasonal split influenza vaccine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adults aged 18-60 years old
- Be able to show legal identity card for the sake of recruitment Without vaccination history of seasonal split influenza vaccine in the recent 3 years
- Not participate in any other clinical trials during the study
- Not receive any immunosuppressive agents during and one month prior to the study
- Be able to understand and sign the informed consent.
Key exclusion criteria (11 listed)
- Woman： Who breast-feeding or planning to become pregnant during the study
- Any history of allergic reactions; was allergic to any component of the vaccine, such as eggs or ovalbumin
- Any history of severe adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Autoimmune disease or immunodeficiency
- Acute episode of chronic diseases or conditions, including chronic hepatitis, hypertension, diabetes mellitus and cardiovascular diseases
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 |
|---|---|---|
| seasonal split influenza vaccine0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime | Biological | 1: Lot 1 |
| seasonal split influenza vaccine0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime | Biological | 2: Lot 2 |
| seasonal split influenza vaccine0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime | Biological | 3: Lot 3 |
| seasonal split influenza vaccine0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime | Biological | 4: control vaccine |
Primary outcome
Haemagglutination-inhibition (HI) antibody titer of influenza A H1N1, influenza A H3N2 and influenza B
Time frame: 0, 21 days
1 secondary outcome
local and systematic adverse reactions after vaccination
Time frame: within 3 days after vaccination
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 9 Nov 2007.
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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.
Zhilun Zhang principal investigator
Tianjin centers for Disease Control and Prevention
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing seasonal split influenza vaccine in people with Influenza, run by Sinovac Biotech 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 5 inclusion and 11 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 9 Nov 2007. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Haemagglutination-inhibition (HI) antibody titer of influenza A H1N1, influenza A H3N2 and influenza B (time frame: 0, 21 days). 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 9 Nov 2007.