InfluenzaPhase 2NCT00956202
A Study of Inactivated Swine-Origin A/H1N1 Influenza Vaccines in Healthy European Subjects Aged 3 to 17 Years
A Phase 2 study testing Swine A/H1N1 influenza vaccine (split virion, inactivated) and Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant) in people with Influenza and Swine-origin A/H1N1 Influenza, run by Sanofi Pasteur, a Sanofi Company at 15 sites in Finland.
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 vaccines 21 days after each vaccination in all participants. Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy 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) and Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 15 sitesFinland
- Study dates
- Aug 2009to Nov 2010
- 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 3 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All subjects:
- Provision of Informed Consent Form signed by the subject's parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 8 to 12 years, and of Informed Consent Form signed by subjects >12 years.
- Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
- Subjects aged 12 to 17 years:
- Aged 12 to 17 years on the day of inclusion
- For a female of childbearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination.
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- Subjects aged 3 to 11 years:
- Aged 3 to 11 years on the day of inclusion
- At Visit 05 (Month 8), for antibody persistence assessment:
- Having received two injections of the 15 µg HA vaccine (Group 1) or of the 3.8 µg HA + AF03 vaccine (Group 2)
- Addendum 1 to Informed Consent Form has been signed by the subject's parent(s)/guardian(s) (and by an independent witness if required by local regulations). In addition, provision of addendum 1 to Assent Form signed by subjects aged 6 to 11 years, and of addendum 1 to Informed Consent Form signed by subjects ≥ 12 years.
- At Visit 06, for participants eligible for the Antibody persistence evaluation who will receive the 2010-2011 Northern Hemisphere (NH) seasonal Trivalent Influenza Vaccine:
- Addendum 2 to Informed Consent Form has been signed by the subject and/or subject's parent(s)/guardian(s) (and by an independent witness if required by local regulations). In addition, provision of addendum 2 to Assent Form signed by subjects aged 6 to 11 years, and of addendum 2 to Informed Consent Form signed by subjects ≥ 12 years.
Who cannot join
- All subjects:
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a 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 trial vaccinations
- Planned receipt of any vaccine prior to the Day 42 blood sample
- Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
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- Known or suspected congenital or acquired immunodeficiency, 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)
- Seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B antigen, or Hepatitis C as reported by parents/legal representative
- 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
- Thrombocytopenia contraindicating intramuscular (IM) vaccination as reported by parents/legal representative
- 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
- 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)
- Subjects aged 12 to 17 years:
- Known pregnancy, or a positive urine pregnancy test
- Currently breastfeeding a child
- Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
- At Visit 05 (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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Finland15 sites
Study site
Espoo, FIN-02100
Study site
Helsinki, FIN-00100
Study site
Helsinki, FIN-00930
Study site
Jarvenpaa, FIN-04400
Study site
Kokkola, 67100
Study site
Kotka, FIN-48600
Study site
Kuopio, FIN-70100
Study site
Lahti, FIN-15140
Study site
Oulu, FIN-90220
Study site
Pori, FIN-28100
Study site
Seinäjoki, 60100
Study site
Tampere, FIN-33100
Study site
Turku, FIN-20520
Study site
Vantaa, FIN-01300
Study site
Vantaa, FIN-01600
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 Subjects Aged 3 to 17 Years
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 vaccines 21 days after each vaccination in all participants.
- To describe the antibody persistence eight months after the first vaccine administration using HAI method, in a subset of participants 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 NH seasonal TIV administered approximately 13 months after the first vaccination in the subset of participants who received two injections.
- To describe the safety profile of each vaccine 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 children and adolescents participants eligible for the antibody persistence evaluation were sampled 8 months after the first vaccination, they will also be proposed to receive the 2010-2011 Northern Hemisphere (NH) seasonal Trivalent Influenza Vaccine (TIV) 13 months after the first vaccination. Immunogenicity response will be evaluated before vaccination and 21 days after vaccination with TIV, respectively.
- Conditions
- Influenza, Swine-origin A/H1N1 Influenza
- Being tested
- Swine A/H1N1 influenza vaccine (split virion, inactivated), Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant)
- Keywords
- Influenza, Pandemic Flu, Swine-origin A/H1N1 Influenza, Inactivated split-virion vaccine, Adjuvant
- 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 a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset)
Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant)Biological
0.5 mL, Intramuscular on Day 0 and Day 21 (all participants); and 0.5 mL of a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset).
Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant)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 Influenza vaccine formulation 1 at Visits 1 and 2; a subset will receive a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset). Receives: Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated) |
| A/H1N1 Vaccine Group 2 | Experimental | All participants will receive A/H1N1 Influenza vaccine formulation 2 at Visits 1 and 2; a subset will receive a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset). Receives: Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant) |
| A/H1N1 Vaccine Group 3 | Experimental | Participants will receive A/H1N1 Influenza vaccine formulation 3 Receives: Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity: To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccines
Measured: 21 days post vaccination
Safety: To provide information concerning the safety (in terms of solicited injection site and systemic reactions and unsolicited adverse events) of Swine A/H1N1 influenza vaccines.
Measured: 0-7 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 posted11 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2010
- Study completionNov 2010
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
- 303 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
- NCT00956202
- Sponsor's protocol ID
- GPF08
- Other IDs
- UTN: U1111-1111-4962, 2009-013346-83, 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 Subjects Aged 3 to 17 Years
- ClinicalTrials.gov ID
- NCT00956202
- Acronym / sponsor ID
- GPF08
- Conditions
- Influenza, Swine-origin A/H1N1 Influenza
- Keywords
- Influenza, Pandemic Flu, Swine-origin A/H1N1 Influenza, Inactivated split-virion vaccine, Adjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 11 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 vaccines 21 days after each vaccination in all participants.
- To describe the antibody persistence eight months after the first vaccine administration using HAI method, in a subset of participants 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 NH seasonal TIV administered approximately 13 months after the first vaccination in the subset of participants who received two injections.
- To describe the safety profile of each vaccine 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 children and adolescents participants eligible for the antibody persistence evaluation were sampled 8 months after the first vaccination, they will also be proposed to receive the 2010-2011 Northern Hemisphere (NH) seasonal Trivalent Influenza Vaccine (TIV) 13 months after the first vaccination. Immunogenicity response will be evaluated before vaccination and 21 days after vaccination with TIV, respectively.
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 Influenza vaccine formulation 1 at Visits 1 and 2; a subset will receive a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset). |
| A/H1N1 Vaccine Group 2 | Experimental | Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant)All participants will receive A/H1N1 Influenza vaccine formulation 2 at Visits 1 and 2; a subset will receive a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset). |
| A/H1N1 Vaccine Group 3 | Experimental | Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant)Participants will receive A/H1N1 Influenza vaccine formulation 3 |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Provision of Informed Consent Form signed by the subject's parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 8 to 12 years, and of Informed Consent Form signed by subjects >12 years.
- Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
- Aged 12 to 17 years on the day of inclusion
- For a female of childbearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination.
- Aged 3 to 11 years on the day of inclusion
Key exclusion criteria (24 listed)
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a 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 trial vaccinations
- Planned receipt of any vaccine prior to the Day 42 blood sample
- Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
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 a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset) | Biological | A/H1N1 Vaccine Group 1 |
| Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant)0.5 mL, Intramuscular on Day 0 and Day 21 (all participants); and 0.5 mL of a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset). | Biological | A/H1N1 Vaccine Group 2 |
| Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant)0.5 mL, Intramuscular on Day 0 and day 21 | Biological | A/H1N1 Vaccine Group 3 |
Primary outcome
Immunogenicity: To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccines
Time frame: 21 days post vaccination
Safety: To provide information concerning the safety (in terms of solicited injection site and systemic reactions and unsolicited adverse events) of Swine A/H1N1 influenza vaccines.
Time frame: 0-7 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.
15 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) and Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant) in people with Influenza and Swine-origin A/H1N1 Influenza, run by Sanofi Pasteur, a Sanofi Company at 15 sites in Finland.
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 13 inclusion and 24 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 15 sites in Finland. 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?
Immunogenicity: To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccines (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.