Swine-Origin Influenza A H1N1 VirusNCT01098786
Drug Use Investigation for Cell-culture Derived Influenza A (H1N1) Emulsion HA Vaccine
An observational study of Swine-Origin Influenza A H1N1 Virus, run by Novartis Vaccines at 1 site in Japan.
Trial summary
This is to evaluate safety of cell-derived A/H1N1 influenza HA vaccine in healthy Japanese subjects. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Swine-Origin Influenza A H1N1 Virus
- What is being tested?
- Cell-derived A/H1N1 influenza HA vaccine
- Type of treatment
- Vaccines
- How many people
- 556 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2010to Nov 2010
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Community sample
Who may be able to join
- 1. Healthy Japanese
Who cannot join
- The person has received any other company's new influenza vaccine (swine-derived A/H1N1) before vaccination with this product.
- The person has participated in any clinical study of this product or any other company's new influenza vaccine (swine-derived A/H1N1) and received the investigational vaccine.
- The person is regarded as a subject in one of the following items 3) to 6) who is not appropriate to receive preventive vaccination as described in the current package insert.
- The person shows obvious fever.
- The person obviously suffers from serious acute disease.
- The person has obviously shown anaphylaxis due to an ingredient of this vaccine.
- The person is otherwise in an inappropriate state to receive preventive vaccination.
Trial locations and contacts
1 site in 1 country.
Japan1 site
National Hospital Organization Kumamoto Medical Center
Chuo-ku, Kumamoto, 860-0008
About this study
Official title: Observational Study to Evaluate Safety of Cell-derived A/H1N1 Influenza HA Vaccine in Healthy Japanese Subjects
This is to evaluate safety of cell-derived A/H1N1 influenza HA vaccine in healthy Japanese subjects.
- Conditions
- Swine-Origin Influenza A H1N1 Virus
- Being tested
- Cell-derived A/H1N1 influenza HA vaccine
- Keywords
- Influenza A, H1N1 subtype, Vaccine, Adjuvant, Cell culture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell-derived A/H1N1 influenza HA vaccineBiological
Single group vaccinated
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Not described Receives: Biological: Cell-derived A/H1N1 influenza HA vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate clinical symptoms according to the subject background after vaccination
Measured: 28 days
Secondary outcomes (1)
The kinds, degrees, durations and onset ratios of adverse events
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swine-Origin Influenza A H1N1 VirusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 556 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098786
- Sponsor's protocol ID
- V110_11
- Status last verified
- Mar 2017
- First submitted
- 31 Mar 2010
- Last updated
- 14 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate Safety of Cell-derived A/H1N1 Influenza HA Vaccine in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT01098786
- Acronym / sponsor ID
- V110_11
- Conditions
- Swine-Origin Influenza A H1N1 Virus
- Keywords
- Influenza A, H1N1 subtype, Vaccine, Adjuvant, Cell culture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 556 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 5 Apr 2010 (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.
This is to evaluate safety of cell-derived A/H1N1 influenza HA vaccine in healthy Japanese subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Biological: Cell-derived A/H1N1 influenza HA vaccine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (1 listed)
- 1. Healthy Japanese
Key exclusion criteria (7 listed)
- The person has received any other company's new influenza vaccine (swine-derived A/H1N1) before vaccination with this product.
- The person has participated in any clinical study of this product or any other company's new influenza vaccine (swine-derived A/H1N1) and received the investigational vaccine.
- The person is regarded as a subject in one of the following items 3) to 6) who is not appropriate to receive preventive vaccination as described in the current package insert.
- The person shows obvious fever.
- The person obviously suffers from serious acute disease.
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 |
|---|---|---|
| Cell-derived A/H1N1 influenza HA vaccineSingle group vaccinated | Biological | Healthy |
Primary outcome
Evaluate clinical symptoms according to the subject background after vaccination
Time frame: 28 days
1 secondary outcome
The kinds, degrees, durations and onset ratios of adverse events
Time frame: 28 days
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 14 Mar 2017.
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?
An observational study of Swine-Origin Influenza A H1N1 Virus, run by Novartis Vaccines at 1 site in Japan.
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 1 inclusion and 7 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 14 Mar 2017. 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 Japan. 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?
Evaluate clinical symptoms according to the subject background after vaccination (time frame: 28 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 14 Mar 2017.