InfluenzaPhase 4NCT01654809
Safety and Immunogenicity Study of Split Influenza Virus Vaccine in Different Age Groups
A Phase 4 study testing evaluated vaccine, imported compared vaccine and domestic compared vaccine in people with Influenza, run by Beijing Center for Disease Control and Prevention at 2 sites in China.
Trial summary
The purpose of this study is to observe the adverse reaction ratio and hemagglutination inhibition (HI) antibody positive rate, Geometric mean titer (GMT) of three brands split influenza virus vaccine in different 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?
- evaluated vaccine, imported compared vaccine and domestic compared 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
- 2 sitesChina
- Study dates
- Aug 2010to Jun 2011
- 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 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- participants were enrolled (toddlers: 6 months to 3 years; school-aged children: 6 to 12 years and older adults: ≥60 years）
- Eligible participants were generally healthy or had stable chronic medical conditions (for older adults only)
Who cannot join
- History of allergic reaction to any component of the study vaccines or previous influenza vaccine
- History of systemic hypersensitivity to hens' eggs
- History of Guillain Barré syndrome following administration of any influenza vaccine
- Any immunodeficient or immunocompromised conditions
- Receipt of cytotoxic or immunosuppressive drugs within the past 6 months
- Receipt of blood-derived product within the past 3 months
Show all 10Show fewer
- Receipt of any vaccine within one month prior to study entry with exception of paediatric routine vaccination
- Receipt of non-study 2010-2011 seasonal TIV
- Participation in any other study with a non-approved drug during the study
- Acute febrile disease and other self-limiting illness were the temporary exclusion criteria
Trial locations and contacts
2 sites in 1 country.
China2 sites
Jiuyuan Center for Disease Control and Prevention
Baotou, Inner Mongolia
Sanhe Centre for Disease Control and Prevention
Langfang, Hebei
About this study
Official title: Evaluation of Safety and Immunogenicity Among Different Age-groups Receiving Different Split Influenza Vaccines
The purpose of this study is to observe the adverse reaction ratio and hemagglutination inhibition (HI) antibody positive rate, Geometric mean titer (GMT) of three brands split influenza virus vaccine in different population.
Read the detailed description
Observational Objectives:
To describe the safety of evaluated vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to ≤ 36 months,6th to 12th birthday and ≥ 60th birthday.
To describe the immunogenicity of evaluated vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to ≤ 36 months, 6th to 12th birthday and ≥ 60rd birthday.
- Conditions
- Influenza
- Being tested
- evaluated vaccine, imported compared vaccine, domestic compared 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.
evaluated vaccineBiological
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
imported compared vaccineBiological
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
domestic compared vaccineBiological
0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
| Study group | Role | What they receive |
|---|---|---|
| evaluated vaccine | Experimental | 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose) Receives: Biological: evaluated vaccine; Biological: imported compared vaccine; Biological: domestic compared vaccine |
| imported compared vaccine | Active comparator | 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose) Receives: Biological: evaluated vaccine; Biological: imported compared vaccine; Biological: domestic compared vaccine |
| domestic compared vaccine | Active comparator | 0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose) Receives: Biological: evaluated vaccine; Biological: imported compared vaccine; Biological: domestic compared vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the immunogenicity of evaluated vaccine
The immunologic equivalence of 7days after vaccination of influenza virus vaccine was measured in terms of GMTs.
Measured: 6 months
To evaluate the safety
The incidence of adverse events was analyzed statistically
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startAug 2010
- Primary completionFeb 2011
- Study completionJun 2011
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Center for Disease Control and Prevention
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nianmin Shi, Master, Study chair, Beijing Chaoyang District Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654809
- Sponsor's protocol ID
- BJCDPC-1
- Status last verified
- Jul 2012
- First submitted
- 28 Jul 2012
- Last updated
- 2 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Immunogenicity Among Different Age-groups Receiving Different Split Influenza Vaccines
- ClinicalTrials.gov ID
- NCT01654809
- Acronym / sponsor ID
- BJCDPC-1
- Conditions
- Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Beijing Center for Disease Control and PreventionOther government
- Study start
- Aug 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 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.
The purpose of this study is to observe the adverse reaction ratio and hemagglutination inhibition (HI) antibody positive rate, Geometric mean titer (GMT) of three brands split influenza virus vaccine in different population.
Detailed description
Observational Objectives:
To describe the safety of evaluated vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to ≤ 36 months,6th to 12th birthday and ≥ 60th birthday.
To describe the immunogenicity of evaluated vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to ≤ 36 months, 6th to 12th birthday and ≥ 60rd birthday.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| evaluated vaccine | Experimental | Biological: evaluated vaccine, Biological: imported compared vaccine, Biological: domestic compared vaccine0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose) |
| imported compared vaccine | Active comparator | Biological: evaluated vaccine, Biological: imported compared vaccine, Biological: domestic compared vaccine0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose) |
| domestic compared vaccine | Active comparator | Biological: evaluated vaccine, Biological: imported compared vaccine, Biological: domestic compared vaccine0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose) |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- participants were enrolled (toddlers: 6 months to 3 years; school-aged children: 6 to 12 years and older adults: ≥60 years）
- Eligible participants were generally healthy or had stable chronic medical conditions (for older adults only)
Key exclusion criteria (10 listed)
- History of allergic reaction to any component of the study vaccines or previous influenza vaccine
- History of systemic hypersensitivity to hens' eggs
- History of Guillain Barré syndrome following administration of any influenza vaccine
- Any immunodeficient or immunocompromised conditions
- Receipt of cytotoxic or immunosuppressive drugs within the past 6 months
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 |
|---|---|---|
| evaluated vaccine0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose) | Biological | domestic compared vaccine, evaluated vaccine, imported compared vaccine |
| imported compared vaccine0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose) | Biological | domestic compared vaccine, evaluated vaccine, imported compared vaccine |
| domestic compared vaccine0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose) | Biological | domestic compared vaccine, evaluated vaccine, imported compared vaccine |
Primary outcome
To evaluate the immunogenicity of evaluated vaccine
Time frame: 6 months
The immunologic equivalence of 7days after vaccination of influenza virus vaccine was measured in terms of GMTs.
To evaluate the safety
Time frame: 4 months
The incidence of adverse events was analyzed statistically
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 2 Oct 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.
Nianmin Shi, Master study chair
Beijing Chaoyang District Center for Disease Control and Prevention
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing evaluated vaccine, imported compared vaccine and domestic compared vaccine in people with Influenza, run by Beijing Center for Disease Control and Prevention at 2 sites 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 2 inclusion and 10 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 2 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
To evaluate the immunogenicity of evaluated vaccine (time frame: 6 months). The study lists 2 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 2 Oct 2012.