InfluenzaPhase 2NCT00954798
A Study of Swine-origin A/H1N1 Influenza Vaccines in Healthy European Adults and the Elderly
A Phase 2 study testing Swine A/H1N1 influenza vaccine (split virion, inactivated) in people with Influenza and Swine-origin A/H1N1 Influenza, run by Sanofi Pasteur, a Sanofi Company at 6 sites in France.
Trial summary
The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration. Primary objectives: To describe the immune response to study vaccine 21 days after each vaccination. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Swine-origin A/H1N1 Influenza
- What is being tested?
- Swine A/H1N1 influenza vaccine (split virion, inactivated)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 6 sitesFrance
- Study dates
- Aug 2009to Mar 2011
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or over on the day of inclusion
- Informed Consent Form has been signed and dated
- Able to attend all scheduled visits and to comply with all trial procedures
- For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination
- Entitled to national social security
- At Visit 05, for antibody persistence assessment:
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- Addendum 1 to Informed Consent Form has been signed and dated
- Having received two vaccinations with the vaccine formulation 1 or 2.
- At Month 13, for trivalent influenza vaccine (TIV) administration in subjects who received the A/H1N1 influenza vaccine:
- Addendum 2 to Informed Consent Form has been signed and dated
Who cannot join
- Known pregnancy, or a positive urine pregnancy test
- Currently breastfeeding a child
- Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
- Planned receipt of any vaccine prior to the Day 42 blood sample
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- Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
- Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
- Employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator
- Previous participation in a trial investigating a vaccine with the swine-origin A/H1N1 influenza strain
- Confirmed infection with the swine-origin A/H1N1 influenza strain (different from the seasonal strain) in 2009
- Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
- Receipt of any allergy shots and/or seasonal allergy medication in the 7-day period prior to enrollment (vaccination), or scheduled to receive any allergy shots and/or seasonal allergy medication in the 7-day period after enrollment (vaccination)
- At Month 8, for antibody persistence assessment:
- Subjects who received, in the context of a pandemic immunization program, another A/H1N1 pandemic influenza vaccine than the Investigational Medicinal Products.
- Additional criteria for subset to receive only the TIV:
- History of pandemic A/H1N1 influenza vaccination
- History of clinically or laboratory confirmed pandemic A/H1N1 influenza infection
- Receipt of an adjuvanted influenza vaccine in a clinical trial within the previous 12 months
- Planned receipt of any vaccine during the present trial period.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Study site
Angers, 49000
Study site
Château-Gontier, 53200
Study site
Cherbourg, 50100
Study site
Équeurdreville-Hainneville, 50120
Study site
Laval, 53000
Study site
Tiercé, 49125
About this study
Official title: Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Adult and Elderly Subjects
The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.
Primary objectives:
- To describe the immune response to study vaccine 21 days after each vaccination.
- To describe the antibody persistence 8 months after the first vaccine administration using hemagglutination inhibition (HAI) method in a randomized subset of adult subjects who received two injections.
- To describe the immune response against the A/H1N1 strain using HAI method 21 days after a vaccination with the 2010-2011 Northern Hemisphere (NH) seasonal trivalent influenza vaccine (TIV) administered 13 months after the first vaccination in a subset subjects who received the A/H1N1 influenza vaccine and in subjects naïve to the swine origin A/H1N1 strain.
- To describe the safety profiles of study vaccines in all participants.
Read the detailed description
All participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
A subset of the participants will receive a third vaccine injection (2010-2011 Northern Hemisphere [NH] seasonal trivalent influenza vaccine [TIV]) approximately 13 months after the first vaccination; additionally, a subset of participants' naïve to the swine-origin A/H1N1 strain will also receive one vaccine injection of the 2010-2011 NH seasonal TIV.
- Conditions
- Influenza, Swine-origin A/H1N1 Influenza
- Being tested
- Swine A/H1N1 influenza vaccine (split virion, inactivated)
- Keywords
- Influenza, Pandemic Flu, Swine-origin Influenza, Inactivated split-virion vaccine, Adjuvant, Adult
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swine A/H1N1 influenza vaccine (split virion, inactivated)Biological
0.5 mL, Intramuscular on Day 0 and day 21 (all participants); and 0.5 mL of trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset)
Swine A/H1N1 influenza vaccine (split virion, inactivated)Biological
0.5 mL, Intramuscular on Day 0 and day 21 (all participants), and 0.5 mL of trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset).
Swine A/H1N1 influenza vaccine (split virion, inactivated)Biological
0.5 mL, Intramuscular on Day 0 and Day 21
| Study group | Role | What they receive |
|---|---|---|
| A/H1N1 Vaccine Group 1 | Experimental | All participants will receive A/H1N1 vaccine formulation 1 at Visits 1 and 2; a subset will receive a trivalent influenza vaccine (TIV) at Month 13. Receives: Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated) |
| A/H1N1 Vaccine Group 2 | Experimental | All participants will receive A/H1N1 vaccine formulation 2 at Visits 1 and 2; a subset will receive a trivalent influenza vaccine (TIV) at Month 13. Receives: Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated) |
| A/H1N1 Vaccine Group 3 | Experimental | Participants will receive A/H1N1 vaccine formulation 3 Receives: Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccine
Measured: 21 days post-vaccination
To provide information concerning the safety in terms of solicited injection site and systemic reactions following vaccination with Swine A/H1N1 influenza vaccine
Measured: 0 to7 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 posted7 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2010
- Study completionMar 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954798
- Sponsor's protocol ID
- GPF07
- Other IDs
- UTN: U1111-1111-4918, 2009-013344-37, 2009
- Status last verified
- Jan 2014
- First submitted
- 3 Aug 2009
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Adult and Elderly Subjects
- ClinicalTrials.gov ID
- NCT00954798
- Acronym / sponsor ID
- GPF07
- Conditions
- Influenza, Swine-origin A/H1N1 Influenza
- Keywords
- Influenza, Pandemic Flu, Swine-origin Influenza, Inactivated split-virion vaccine, Adjuvant, Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 7 Aug 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.
The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.
Primary objectives:
- To describe the immune response to study vaccine 21 days after each vaccination.
- To describe the antibody persistence 8 months after the first vaccine administration using hemagglutination inhibition (HAI) method in a randomized subset of adult subjects who received two injections.
- To describe the immune response against the A/H1N1 strain using HAI method 21 days after a vaccination with the 2010-2011 Northern Hemisphere (NH) seasonal trivalent influenza vaccine (TIV) administered 13 months after the first vaccination in a subset subjects who received the A/H1N1 influenza vaccine and in subjects naïve to the swine origin A/H1N1 strain.
- To describe the safety profiles of study vaccines in all participants.
Detailed description
All participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
A subset of the participants will receive a third vaccine injection (2010-2011 Northern Hemisphere [NH] seasonal trivalent influenza vaccine [TIV]) approximately 13 months after the first vaccination; additionally, a subset of participants' naïve to the swine-origin A/H1N1 strain will also receive one vaccine injection of the 2010-2011 NH seasonal TIV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A/H1N1 Vaccine Group 1 | Experimental | Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)All participants will receive A/H1N1 vaccine formulation 1 at Visits 1 and 2; a subset will receive a trivalent influenza vaccine (TIV) at Month 13. |
| A/H1N1 Vaccine Group 2 | Experimental | Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)All participants will receive A/H1N1 vaccine formulation 2 at Visits 1 and 2; a subset will receive a trivalent influenza vaccine (TIV) at Month 13. |
| A/H1N1 Vaccine Group 3 | Experimental | Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)Participants will receive A/H1N1 vaccine formulation 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18 years or over on the day of inclusion
- Informed Consent Form has been signed and dated
- Able to attend all scheduled visits and to comply with all trial procedures
- For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination
- Entitled to national social security
Key exclusion criteria (27 listed)
- Known pregnancy, or a positive urine pregnancy test
- Currently breastfeeding a child
- Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Receipt of any vaccine in the 4 weeks preceding the first trial 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 |
|---|---|---|
| Swine A/H1N1 influenza vaccine (split virion, inactivated)0.5 mL, Intramuscular on Day 0 and day 21 (all participants); and 0.5 mL of trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset) | Biological | A/H1N1 Vaccine Group 1 |
| Swine A/H1N1 influenza vaccine (split virion, inactivated)0.5 mL, Intramuscular on Day 0 and day 21 (all participants), and 0.5 mL of trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset). | Biological | A/H1N1 Vaccine Group 2 |
| Swine A/H1N1 influenza vaccine (split virion, inactivated)0.5 mL, Intramuscular on Day 0 and Day 21 | Biological | A/H1N1 Vaccine Group 3 |
Primary outcome
To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccine
Time frame: 21 days post-vaccination
To provide information concerning the safety in terms of solicited injection site and systemic reactions following vaccination with Swine A/H1N1 influenza vaccine
Time frame: 0 to7 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 14 Jan 2014.
- 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 Monitor study director
Sanofi Pasteur Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Swine A/H1N1 influenza vaccine (split virion, inactivated) in people with Influenza and Swine-origin A/H1N1 Influenza, run by Sanofi Pasteur, a Sanofi Company at 6 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 10 inclusion and 27 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 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccine (time frame: 21 days post-vaccination). 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 Jan 2014.