InfluenzaPhase 2NCT00884182
Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Children
A Phase 2 study testing A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in people with Influenza and Orthomyxoviridae Infections, run by Sanofi Pasteur, a Sanofi Company at 13 sites in Finland.
Trial summary
This study is part of an effort to develop an effective vaccination program in children in the event of a pandemic. Study objectives: To describe the safety profiles in the periods following each vaccination in subjects receiving different vaccination schedule. Read more about this study
- Who is it for?
- Ages 6 months to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Orthomyxoviridae Infections, Orthomyxovirus Infections
- What is being tested?
- A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 13 sitesFinland
- Study dates
- Apr 2009to Jun 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 6 months to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All Subjects
- Subject and parent(s)/legal representative able to attend all scheduled visits and to comply with all trial procedures.
- Completion of vaccination according to the national immunization schedule
- Subjects Aged ≥ 2 Years to < 18 Years:
- Aged ≥ 2 years to < 18 years on the day of inclusion.
- Provision of Informed Consent Form signed by the subject's the 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 11 years, and of Informed Consent Form signed by subjects ≥ 12 years.
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- For a female of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to each vaccination, until at least 4 weeks after each vaccination.
- Subjects Aged ≥ 6 Months to < 2 Years:
- Aged ≥ 6 months to < 2 years on the day of inclusion.
- Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg.
- Provision of Informed Consent Form signed by the parent(s) or other legal representative (and by an independent witness if required by local regulations).
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 trial vaccination
- Planned participation in another clinical trial during the present trial period
- 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 corticosteroids therapy
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
- Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
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- Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
- Receipt of Blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
- Receipt of any vaccine in the 4 weeks preceding trial vaccination
- Planned receipt of any vaccine in the 4 weeks following any trial vaccination
- (Known) Human Immunodeficiency Virus (HIV), Hepatitis B surface (HBs) antigen or Hepatitis C seropositivity
- Previous vaccination against avian influenza with either the trial vaccine or another vaccine
- Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
- Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw
- Subjects Aged ≥2 Years to <18 Years:
- For a female of child-bearing potential, known pregnancy or positive urine pregnancy test
- Breast-feeding female
- Febrile illness (temperature ≥ 37.5 °C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
- Subjects Aged ≥ 6 Months to < 2 Years:
- History of seizures
- Febrile illness (temperature ≥ 38 °C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Finland13 sites
Study site
Espoo, FIN-02100
Study site
Helsinki, FIN-00100
Study site
Helsinki, FIN-00930
Study site
Jarvenpaa, FIN-04400
Study site
Kuopio, FIN-70100
Study site
Lahti, FIN-15140
Study site
Oulu, FIN-90220
Study site
Pori, FIN-28100
Study site
Tampere, FIN-33014
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: Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in European Children
This study is part of an effort to develop an effective vaccination program in children in the event of a pandemic.
Study objectives:
- To describe the safety profiles in the periods following each vaccination in subjects receiving different vaccination schedule.
- To describe the immune response after each vaccination in subjects receiving study vaccine.
Read the detailed description
Study participants will receive two administrations of the investigational vaccine at one of 3 vaccination schedules.
- Being tested
- A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine
- Keywords
- Influenza, Orthomyxoviruses, Split Virion Pandemic Influenza Vaccine, A/H5N1
- Medical subject headings
- Influenza, Human, Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A/H5N1 Inactivated, Split Virion Pandemic Influenza VaccineBiological
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants on vaccination schedule 1 (Day 0 and Day 21) Receives: Biological: A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine |
| Group 2 | Experimental | Participants on vaccination schedule 2 (Day 0 and Day 14) Receives: Biological: A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine |
| Group 3 | Experimental | Participants on vaccination schedule 3 (Day 0 and Day 42) Receives: Biological: A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide information concerning the safety of the Split Virion Pandemic Influenza vaccine.
Measured: 21 days post-vaccination and entire study
Secondary outcomes (1)
To provide information concerning the immunogenicity of Split Virion Pandemic Influenza vaccine.
Measured: 21 days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2010
- Study completionJun 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
- 350 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
- NCT00884182
- Sponsor's protocol ID
- GPA12
- Status last verified
- Jan 2014
- First submitted
- 16 Apr 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
- Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in European Children
- ClinicalTrials.gov ID
- NCT00884182
- Acronym / sponsor ID
- GPA12
- Keywords
- Influenza, Orthomyxoviruses, Split Virion Pandemic Influenza Vaccine, A/H5N1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 20 Apr 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 part of an effort to develop an effective vaccination program in children in the event of a pandemic.
Study objectives:
- To describe the safety profiles in the periods following each vaccination in subjects receiving different vaccination schedule.
- To describe the immune response after each vaccination in subjects receiving study vaccine.
Detailed description
Study participants will receive two administrations of the investigational vaccine at one of 3 vaccination schedules.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: A/H5N1 Inactivated, Split Virion Pandemic Influenza VaccineParticipants on vaccination schedule 1 (Day 0 and Day 21) |
| Group 2 | Experimental | Biological: A/H5N1 Inactivated, Split Virion Pandemic Influenza VaccineParticipants on vaccination schedule 2 (Day 0 and Day 14) |
| Group 3 | Experimental | Biological: A/H5N1 Inactivated, Split Virion Pandemic Influenza VaccineParticipants on vaccination schedule 3 (Day 0 and Day 42) |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- All Subjects
- Subject and parent(s)/legal representative able to attend all scheduled visits and to comply with all trial procedures.
- Completion of vaccination according to the national immunization schedule
- Aged ≥ 2 years to < 18 years on the day of inclusion.
- Provision of Informed Consent Form signed by the subject's the 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 11 years, and of Informed Consent Form signed by subjects ≥ 12 years.
Key exclusion criteria (22 listed)
- All subjects
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding trial vaccination
- Planned participation in another clinical trial during the present trial period
- 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 corticosteroids therapy
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
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 |
|---|---|---|
| A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine0.5 mL, Intramuscular | Biological | Group 1, Group 2, Group 3 |
Primary outcome
To provide information concerning the safety of the Split Virion Pandemic Influenza vaccine.
Time frame: 21 days post-vaccination and entire study
1 secondary outcome
To provide information concerning the immunogenicity of Split Virion Pandemic Influenza vaccine.
Time frame: 21 days post-vaccination
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.
13 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 A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in people with Influenza and Orthomyxoviridae Infections, run by Sanofi Pasteur, a Sanofi Company at 13 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 11 inclusion and 22 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 13 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?
To provide information concerning the safety of the Split Virion Pandemic Influenza vaccine. (time frame: 21 days post-vaccination and entire study). 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.