Pandemic Influenza A (H1N1)NCT01040741

Observational Safety Study of Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine

An observational study of Pandemic Influenza A (H1N1) and A New Flu Virus of Swine Origin, run by Novartis Vaccines at 14 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is an observational safety study of a prophylactic use of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Vaccine in subjects 6 months of age and older. Subjects may receive either 1 or 2 doses: children and elderly will receive 2 doses and adults will receive either 1 or 2 doses. Read more about this study

Who is it for?: Ages 6 months and olderHealthy volunteers can take part
Conditions the study is for: Pandemic Influenza A (H1N1), A New Flu Virus of Swine Origin
What is being tested?: Non-intervention observational study
How many people: 7,284 participants
Where: 14 sitesin 2 countries
Study dates: Dec 2009to Mar 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

Subject's age in accordance with the approved product label of the country where the study is conducted
Subjects will be vaccinated with Focetria®, 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

14 sites in 2 countries.

Country

City, postcode or hospital

14 sites in 2 countries

Netherlands8 sites

Huisartsenpraktijk Bredero
Brederostraat 2/A, Breda, 4819HH
Huisartsenpraktijk Dennenlaan
Dennenlaan 56, Emmen, 7822EL
Huisartsenpraktijk Oosterhesselen
Edveensweg 13, Oosterhesselen, 7861AM
Isala Klinieken Zwolle
Groot Wezenland 20, Zwolle, 8011JW
Huisartsenpraktijk Bergentheim
Kanaalweg West 61, Bergentheim, 7691BV
Saxenburg Groep, Zorgcentrum Aleida Kramer
M.v.d. Thijnensingel 1, Coevorden, 7741GB
Huisartsenpraktijk de Steenpoort
Prinses Julianastraat 25, Genemuiden, 8281CK
Huisartsenpraktijk Gramsbergen
Voorstraat 3, Gramsbergen, 7783AL

Other trials in Netherlands

Argentina6 sites

Hospital Pediatrico "Dr. Humberto Notti"
Bandera de Los Andes 2603 Villa Nueva, Guaymallen Mendoza
Hospital Nuestra Señora de la Misericordia
Belgrano 1500, Córdoba Province
Hospital Pediatrico del Niño Jesus
Castro Barros 650 - San Martín, Córdoba Province
Hospital Garrahan
Combate de Los Pozos 1881, Buenos Aires F.D.
Hospital de Ninos "Dr. Ricardo Gutierrez"
Gallo 1330, Buenos Aires F.D.
Sanatorio Mayo Privado S.A.
Humberto Primo 520, Córdoba Province

Other trials in Argentina

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 Focetria

Conditions: Pandemic Influenza A (H1N1), A New Flu Virus of Swine Origin
Being tested: Non-intervention observational study
Keywords: Pandemic influenza A (H1N1) vaccine, Adjuvanted

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 groups in NCT01040741
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 Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects; 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 with Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2009Mar 2011

First posted30 Dec 2009 (estimated)
Study startDec 2009
Primary completionMar 2011
Study completionMar 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pandemic 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: 7,284 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01040741
Sponsor's protocol ID: V111_09OB
Status last verified: Oct 2011
First submitted: 29 Dec 2009
Last updated: 5 Oct 2011
Results posted: No

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2011. 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 Focetria
ClinicalTrials.gov ID: NCT01040741
Acronym / sponsor ID: V111_09OB
Conditions: Pandemic Influenza A (H1N1), A New Flu Virus of Swine Origin
Keywords: Pandemic influenza A (H1N1) vaccine, Adjuvanted
Study type: Observational
Recruitment status: Completed
Enrolment: 7,284 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 30 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.

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)

Subject's age in accordance with the approved product label of the country where the study is conducted
Subjects will be vaccinated with Focetria®, 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 Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects; 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 with Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine.
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 5 Oct 2011.

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.

14 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pandemic Influenza A (H1N1) and A New Flu Virus of Swine Origin, run by Novartis Vaccines at 14 sites in 2 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 5 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 14 sites in Netherlands, Argentina. 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 Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects; To characterize the incidence of AEs in specific age groups following an active surveillance of vaccinated subjects. (time frame: 6 Months). 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 NCT01040741.

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 5 Oct 2011.