InfluenzaNCT01032980
Post Authorization Safety Study of the Pandemic A/H1N1 Influenza Vaccines in Children and Adults
An observational study of Influenza and Swine-Origin A/H1N1 Influenza Virus, run by Sanofi Pasteur, a Sanofi Company at 5 sites in France.
Trial summary
This study is designed to assess the safety of the approved and licensed HUMENZA (adjuvanted A/H1N1 pandemic influenza vaccine) and PANENZA (non-adjuvanted A/H1N1 pandemic influenza vaccine) to meet regulatory requirements for post-marketing safety monitoring. Read more about this study
- Who is it for?
- Ages 2 months and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Swine-Origin A/H1N1 Influenza Virus
- Type of treatment
- Vaccines
- How many people
- 3,934 participants
- Where
- 5 sitesFrance
- Study dates
- Dec 2009to Jul 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 2 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants will be vaccinated with HUMENZA or PANENZA according to the recommendations provided in the product leaflet and local recommendations. The HUMENZA Group will be divided in 6 defined age groups; the PANENZA Group will be divided into 2 defined age groups.
Who may be able to join
- Aged 2 months and above on the day of inclusion
- Having received HUMENZA or PANENZA
- Provision of the Contact Order Form (COF) signed by the participant or the participant's parent(s)/guardians(s)
- Participant or the participant's parent(s)/legal representative(s) are able to attend all scheduled visits and to comply with all study procedures
Who cannot join
- Participant previously vaccinated with another A/H1N1 pandemic vaccine
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Study site
Bordeaux, 33000
Study site
Lille, 59000
Study site
Lyon, 69000
Study site
Marseille, 13000
Study site
Paris, 75000
About this study
Official title: Post Authorization Safety Study of the Intramuscular Inactivated, Split Virion Pandemic A/H1N1 Influenza Vaccines in Children Aged Over 2 Months and in Adult Populations
This study is designed to assess the safety of the approved and licensed HUMENZA (adjuvanted A/H1N1 pandemic influenza vaccine) and PANENZA (non-adjuvanted A/H1N1 pandemic influenza vaccine) to meet regulatory requirements for post-marketing safety monitoring.
Primary objective:
Read more
To describe the incidence of serious adverse events and adverse events of special interest (AESIs) after HUMENZA or PANENZA administration throughout the study in different age groups.
Secondary objective:
To describe the incidence of non-serious cutaneous allergic reactions after HUMENZA or PANENZA administration in different age groups up to 21 days after the last vaccination.This study is designed to assess the safety of the approved and licensed HUMENZA (adjuvanted A/H1N1 pandemic influenza vaccine) and PANENZA (non-adjuvanted A/H1N1 pandemic influenza vaccine) to meet regulatory requirements for post-marketing safety monitoring.
Read the detailed description
All participants will be vaccinated with study vaccines (1 or 2 doses) at the start of the study and will be monitored for safety for up to 6 months after the last vaccination.
- Conditions
- Influenza, Swine-Origin A/H1N1 Influenza Virus
- Keywords
- HUMENZA, PANENZA, Influenza, Swine-Origin Influenza A H1N1 Virus, Influenza virus vaccines
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HUMENZA Vaccine Group | Participants vaccinated with HUMENZA according to the recommendations provided in the product leaflet and local recommendations. | |
| PANENZA Vaccine Group | Participants vaccinated with PANENZA according to the recommendations provided in the product leaflet and local recommendations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: To provide information concerning the safety of HUMENZA and PANENZA vaccines.
Measured: 21 days post-vaccination and entire study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJan 2011
- Study completionJul 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.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- 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
- 3,934 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032980
- Sponsor's protocol ID
- GPF11
- Other IDs
- UTN: U1111-1112-2748
- Status last verified
- Sep 2015
- First submitted
- 15 Dec 2009
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Authorization Safety Study of the Intramuscular Inactivated, Split Virion Pandemic A/H1N1 Influenza Vaccines in Children Aged Over 2 Months and in Adult Populations
- ClinicalTrials.gov ID
- NCT01032980
- Acronym / sponsor ID
- GPF11
- Conditions
- Influenza, Swine-Origin A/H1N1 Influenza Virus
- Keywords
- HUMENZA, PANENZA, Influenza, Swine-Origin Influenza A H1N1 Virus, Influenza virus vaccines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,934 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 16 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 study is designed to assess the safety of the approved and licensed HUMENZA (adjuvanted A/H1N1 pandemic influenza vaccine) and PANENZA (non-adjuvanted A/H1N1 pandemic influenza vaccine) to meet regulatory requirements for post-marketing safety monitoring.
Primary objective:
To describe the incidence of serious adverse events and adverse events of special interest (AESIs) after HUMENZA or PANENZA administration throughout the study in different age groups.
Secondary objective:
To describe the incidence of non-serious cutaneous allergic reactions after HUMENZA or PANENZA administration in different age groups up to 21 days after the last vaccination.This study is designed to assess the safety of the approved and licensed HUMENZA (adjuvanted A/H1N1 pandemic influenza vaccine) and PANENZA (non-adjuvanted A/H1N1 pandemic influenza vaccine) to meet regulatory requirements for post-marketing safety monitoring.
Detailed description
All participants will be vaccinated with study vaccines (1 or 2 doses) at the start of the study and will be monitored for safety for up to 6 months after the last vaccination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HUMENZA Vaccine Group | – | –Participants vaccinated with HUMENZA according to the recommendations provided in the product leaflet and local recommendations. |
| PANENZA Vaccine Group | – | –Participants vaccinated with PANENZA according to the recommendations provided in the product leaflet and local recommendations. |
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be vaccinated with HUMENZA or PANENZA according to the recommendations provided in the product leaflet and local recommendations. The HUMENZA Group will be divided in 6 defined age groups; the PANENZA Group will be divided into 2 defined age groups.
Key inclusion criteria (4 listed)
- Aged 2 months and above on the day of inclusion
- Having received HUMENZA or PANENZA
- Provision of the Contact Order Form (COF) signed by the participant or the participant's parent(s)/guardians(s)
- Participant or the participant's parent(s)/legal representative(s) are able to attend all scheduled visits and to comply with all study procedures
Key exclusion criteria (1 listed)
- Participant previously vaccinated with another A/H1N1 pandemic vaccine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety: To provide information concerning the safety of HUMENZA and PANENZA vaccines.
Time frame: 21 days post-vaccination and entire study duration
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 28 Sep 2015.
- Related InfoLink provided by the sponsor.
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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.
Medical Director study director
Sanofi Pasteur Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza and Swine-Origin A/H1N1 Influenza Virus, run by Sanofi Pasteur, a Sanofi Company at 5 sites in France.
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 4 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 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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: To provide information concerning the safety of HUMENZA and PANENZA vaccines. (time frame: 21 days post-vaccination and entire study duration). 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 28 Sep 2015.