Influenza A (H1N1)NCT01101074
Observational Safety and Effectiveness Study of Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine
An observational study of Influenza A (H1N1), run by Novartis Vaccines at 1 site in Italy.
Trial summary
This observational study will evaluate the safety and effectiveness following administration of adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine through both an ad hoc active monitoring system and a passive surveillance of hospitalization in a large cohort. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza A (H1N1)
- What is being tested?
- This is non-intervention observational study
- How many people
- 135,469 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2009to Sep 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 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Population of children, adolescents, adults and elderly
Who may be able to join
- Subjects resident in Emilia-Romagna and either registered with the AUSL of Reggio Emilia, Bologna, Modena and Parma or working in the province of Reggio Emilia, Bologna, Modena and Parma included in the target groups described in the Study Protocol vaccination with H1N1sw vaccine Focetria is recommended - according to the national pandemic plan adopted at the local level - will be eligible for enrolment.
Who cannot join
- Subjects already vaccinated with another pandemic vaccine or with known contraindications to Focetria, will be excluded from this study.
- Patients institutionalized in Hospital, Nursing Homes, Rehabilitation Centers, as well as home-cared patients, will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Observational Study of Safety and Effectiveness Following Administration of Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine
This observational study will evaluate the safety and effectiveness following administration of adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine through both an ad hoc active monitoring system and a passive surveillance of hospitalization in a large cohort.
- Conditions
- Influenza A (H1N1)
- Being tested
- This is non-intervention observational study
- Keywords
- Swine Flu A (H1N1) vaccine, Adjuvanted flu egg derived, Novel influenza A (H1N1): a new flu virus of swine origin
- Medical subject headings
- Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is non-intervention observational studyOther
This is non-intervention observational study
| Study group | Role | What they receive |
|---|---|---|
| 6-23 months | Not described Receives: Other: This is non-intervention observational study | |
| 2-8 years | Not described Receives: Other: This is non-intervention observational study | |
| 9-17 years | Not described Receives: Other: This is non-intervention observational study | |
| 18-44 years | Not described Receives: Other: This is non-intervention observational study | |
| 45-60 years | Not described Receives: Other: This is non-intervention observational study | |
| >60 years | Not described Receives: Other: This is non-intervention observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine by estimating the incidence of reported Adverse Events, Serious Adverse Events or Adverse Events of Special Interest in a cohort of actively monitored vaccinated subjects
Measured: Within 3 weeks and 6 weeks after vaccine administration
Secondary outcomes (1)
The occurrence of hospitalization within 6 weeks and 2 years after vaccination in a cohort of subjects vaccinated sw unvaccinated subjects, with Flu Egg Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startOct 2009
- Primary completionJan 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Influenza A (H1N1)Studies 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
- 135,469 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
- NCT01101074
- Sponsor's protocol ID
- V111_05
- Status last verified
- Oct 2011
- First submitted
- 1 Apr 2010
- Last updated
- 12 Oct 2011
- Results posted
- No
Publications
Moro ML, Nobilio L, Voci C, Di Mario S, Candela S, Magrini N; SaFoH1N1 working group. A population based cohort study to assess the safety of pandemic influenza vaccine Focetria in Emilia-Romagna region, Italy - part two. Vaccine. 2013 Feb 27;31(10):1438-46. doi: 10.1016/j.vaccine.2012.07.090. Epub 2012 Aug 10.
PubMed 22885015Candela S, Pergolizzi S, Ragni P, Cavuto S, Nobilio L, Di Mario S, Dragosevic V, Groth N, Magrini N; SaFoH1N1 working group. An early (3-6 weeks) active surveillance study to assess the safety of pandemic influenza vaccine Focetria in a province of Emilia-Romagna region, Italy - part one. Vaccine. 2013 Feb 27;31(10):1431-7. doi: 10.1016/j.vaccine.2012.06.030. Epub 2012 Jul 2.
PubMed 22766247
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Safety and Effectiveness Following Administration of Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine
- ClinicalTrials.gov ID
- NCT01101074
- Acronym / sponsor ID
- V111_05
- Conditions
- Influenza A (H1N1)
- Keywords
- Swine Flu A (H1N1) vaccine, Adjuvanted flu egg derived, Novel influenza A (H1N1): a new flu virus of swine origin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135,469 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 9 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 observational study will evaluate the safety and effectiveness following administration of adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine through both an ad hoc active monitoring system and a passive surveillance of hospitalization in a large cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 6-23 months | – | Other: This is non-intervention observational study |
| 2-8 years | – | Other: This is non-intervention observational study |
| 9-17 years | – | Other: This is non-intervention observational study |
| 18-44 years | – | Other: This is non-intervention observational study |
| 45-60 years | – | Other: This is non-intervention observational study |
| >60 years | – | Other: This is non-intervention observational study |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population of children, adolescents, adults and elderly
Key inclusion criteria (1 listed)
- Subjects resident in Emilia-Romagna and either registered with the AUSL of Reggio Emilia, Bologna, Modena and Parma or working in the province of Reggio Emilia, Bologna, Modena and Parma included in the target groups described in the Study Protocol vaccination with H1N1sw vaccine Focetria is recommended - according to the national pandemic plan adopted at the local level - will be eligible for enrolment.
Key exclusion criteria (2 listed)
- Subjects already vaccinated with another pandemic vaccine or with known contraindications to Focetria, will be excluded from this study.
- Patients institutionalized in Hospital, Nursing Homes, Rehabilitation Centers, as well as home-cared patients, will also be excluded.
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 |
|---|---|---|
| This is non-intervention observational studyThis is non-intervention observational study | Other | 18-44 years, 2-8 years, 45-60 years, 6-23 months, 9-17 years, >60 years |
Primary outcome
Safety of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine by estimating the incidence of reported Adverse Events, Serious Adverse Events or Adverse Events of Special Interest in a cohort of actively monitored vaccinated subjects
Time frame: Within 3 weeks and 6 weeks after vaccine administration
1 secondary outcome
The occurrence of hospitalization within 6 weeks and 2 years after vaccination in a cohort of subjects vaccinated sw unvaccinated subjects, with Flu Egg Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine
Time frame: 2 years
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 12 Oct 2011.
- Derived from this study: PubMed 22885015Moro ML, Nobilio L, Voci C, Di Mario S, Candela S, Magrini N; SaFoH1N1 working group. A population based cohort study to assess the safety of pandemic influenza vaccine Focetria in Emilia-Romagna region, Italy - part two. Vaccine. 2013 Feb 27;31(10):1438-46. doi: 10.1016/j.vaccine.2012.07.090. Epub 2012 Aug 10.
- Derived from this study: PubMed 22766247Candela S, Pergolizzi S, Ragni P, Cavuto S, Nobilio L, Di Mario S, Dragosevic V, Groth N, Magrini N; SaFoH1N1 working group. An early (3-6 weeks) active surveillance study to assess the safety of pandemic influenza vaccine Focetria in a province of Emilia-Romagna region, Italy - part one. Vaccine. 2013 Feb 27;31(10):1431-7. doi: 10.1016/j.vaccine.2012.06.030. Epub 2012 Jul 2.
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 Influenza A (H1N1), run by Novartis Vaccines at 1 site in Italy.
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 2 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 12 Oct 2011. 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 Italy. 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?
Safety of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine by estimating the incidence of reported Adverse Events, Serious Adverse Events or Adverse Events of Special Interest in a cohort of actively monitored vaccinated subjects (time frame: Within 3 weeks and 6 weeks after vaccine administration). 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 NCT01101074, which also lists 2 linked publications.
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 12 Oct 2011.