Novel Influenza A (H1N1)NCT01037855
Observational Study of Safety of Flu Cell Culture Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine
An observational study of Novel Influenza A (H1N1) and A New Flu Virus of Swine Origin, run by Novartis Vaccines at 10 sites in 4 countries.
Trial summary
This is an observational study of safety and occurrence of influenza-like illness following administration of flu cell culture derived adjuvanted swine origin A (H1N1) pandemic subunit vaccine in subjects 6 months of age and older. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Novel Influenza A (H1N1), A New Flu Virus of Swine Origin
- What is being tested?
- Non-intervention observational study
- How many people
- 4,028 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Dec 2009to Jan 2011
- 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
- Age ≥ 6 months
- Subjects will be vaccinated with Flu Cell Culture Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine, independently of this study.
- Subjects or parent/guardian willing to provide informed consent prior to vaccination administration and complete all of the study, including follow-up contact
Who cannot join
- Received any prior H1N1 vaccination
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Colombia6 sites
Fundación Universitaria de Ciencias de Salud- Hospital San José Calle
Bogotá
Nueva EPS: Centro de Especialistas Barrios Unidos - MEDERI
Calle 66 # 40-07 - Bogotá
Hospital local de Yopal E.S.E
Calle 9 No. 24-37 - Yopal, Casanare
Clinica del Country
Carrera 16 No. 82-57 Bogotá
Hospital Universitario Infantil San José
Carrera 52 No. 67a-71 - Barrios Unidos - Bogotá
CAIMED - Centro de Atencion e Investigación Medica
Cra. 42 A No. 17-50
Switzerland2 sites
Institute of Social and Preventive Medicine, Division of Communicable Diseases
Hirschengraben 84, Ch-8001 Zürich
Policlinique Médicale Universitaire
Rue Du Bugnon 44, Ch-1011 Lausanne
About this study
Official title: A Prospective Observational Study of Safety and Occurrence of Influenza-like Illness Following Administration of Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine Celtura
This is an observational study of safety and occurrence of influenza-like illness following administration of flu cell culture derived adjuvanted swine origin A (H1N1) pandemic subunit vaccine in subjects 6 months of age and older.
- Being tested
- Non-intervention observational study
- Keywords
- Swine Flu H1N1 vaccine, Adjuvanted flu cell culture derived
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-intervention observational studyOther
Non-intervention observational study
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 6-23 months | Not described Receives: Other: Non-intervention observational study | |
| Group 2: 2-8 years | Not described Receives: Other: Non-intervention observational study | |
| Group 3: 9-17 years | Not described Receives: Other: Non-intervention observational study | |
| Group 4: 18-44 years | Not described Receives: Other: Non-intervention observational study | |
| Group 5: 45-60 years | Not described Receives: Other: Non-intervention observational study | |
| Group: >60 years | Not described Receives: Other: Non-intervention observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
To quantify the safety of Flu Cell Culture Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects
Measured: 6 months
To characterize the incidence of AEs in specific age groups following an active surveillance of vaccinated subjects
Measured: 6 months
Secondary outcomes (1)
To assess the occurrence of laboratory confirmed H1N1sw and influenza-like illness following vaccination
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Novel 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
- 4,028 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
- NCT01037855
- Sponsor's protocol ID
- V110_07OB
- Status last verified
- Mar 2017
- First submitted
- 20 Dec 2009
- 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
- A Prospective Observational Study of Safety and Occurrence of Influenza-like Illness Following Administration of Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine Celtura
- ClinicalTrials.gov ID
- NCT01037855
- Acronym / sponsor ID
- V110_07OB
- Keywords
- Swine Flu H1N1 vaccine, Adjuvanted flu cell culture derived
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,028 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 23 Dec 2009 (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 an observational study of safety and occurrence of influenza-like illness following administration of flu cell culture derived adjuvanted swine origin A (H1N1) pandemic subunit vaccine in subjects 6 months of age and older.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1: 6-23 months | – | Other: Non-intervention observational study |
| Group 2: 2-8 years | – | Other: Non-intervention observational study |
| Group 3: 9-17 years | – | Other: Non-intervention observational study |
| Group 4: 18-44 years | – | Other: Non-intervention observational study |
| Group 5: 45-60 years | – | Other: Non-intervention observational study |
| Group: >60 years | – | Other: 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 (3 listed)
- Age ≥ 6 months
- Subjects will be vaccinated with Flu Cell Culture Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine, independently of this study.
- Subjects or parent/guardian willing to provide informed consent prior to vaccination administration and complete all of the study, including follow-up contact
Key exclusion criteria (1 listed)
- Received any prior H1N1 vaccination
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 |
|---|---|---|
| Non-intervention observational studyNon-intervention observational study | Other | Group 1: 6-23 months, Group 2: 2-8 years, Group 3: 9-17 years, Group 4: 18-44 years, Group 5: 45-60 years, Group: >60 years |
Primary outcome
To quantify the safety of Flu Cell Culture Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects
Time frame: 6 months
To characterize the incidence of AEs in specific age groups following an active surveillance of vaccinated subjects
Time frame: 6 months
1 secondary outcome
To assess the occurrence of laboratory confirmed H1N1sw and influenza-like illness following vaccination
Time frame: 6 Months
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.
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Novel Influenza A (H1N1) and A New Flu Virus of Swine Origin, run by Novartis Vaccines at 10 sites in 4 countries.
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 3 inclusion and 1 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 10 sites in Colombia, Switzerland, Chile, Germany. 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?
To quantify the safety of Flu Cell Culture Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects (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 14 Mar 2017.