InfluenzaPhase 2NCT00491985
Safety and Immunogenicity of 2 Formulations of an Intramuscular A/H5N1 Pandemic Influenza Vaccine in Children
A Phase 2 study testing A/H5N1 Inactivated, split-virion pandemic influenza vaccine and A/H5N1 Inactivated, split virion pandemic influenza vaccine in people with Influenza and Orthomyxoviridae Infections, run by Sanofi Pasteur, a Sanofi Company at 1 site in Thailand.
Trial summary
This is an open, randomized, multicenter clinical trial. Objectives: To describe the safety profiles during the 21 days following each primary and booster injection. To describe the immune response 21 days after each primary and booster injection of each formulation. Read more about this study
- Who is it for?
- Ages 6 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Orthomyxoviridae Infections, Influenza A Virus Infection
- What is being tested?
- A/H5N1 Inactivated, split-virion pandemic influenza vaccine and 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
- 240 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2007to 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All subjects:
- Able to attend all scheduled visits and to comply with all trial procedures.
- Children/Adolescents aged ≥ 2 years to < 18 years:
- Aged ≥ 2 years to < 18 years on the day of inclusion.
- Informed Consent Form signed by one parent or another legal representative and by an independent witness if the parent/legal representative is illiterate.
- For a female, inability to bear a child or negative urine pregnancy test (as applicable).
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- For a female of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination (as applicable).
- Infants/toddlers 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 kg.
- Informed Consent Form signed by one parent/legally acceptable representative and an independent witness if the parent/legally acceptable representative is illiterate.
- Subject who completed vaccination according to the national immunization schedule.
Who cannot join
- All subjects:
- Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- 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.
- Systemic hypersensitivity to any of the vaccine components or history of life threatening reaction to the trial vaccine or a vaccine containing the same substances (egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and octoxinol 9).
- Chronic illness at a stage that could interfere with trial conduct or completion.
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- Blood or blood-derived products received in the past 3 months.
- Any vaccination in the 4 weeks preceding the first trial vaccination.
- Vaccination planned in the 4 weeks following any trial vaccination.
- History of the H5N1 infection (confirmed either clinically, serologically or virologically).
- Known HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity.
- Previous vaccination with an avian flu vaccine.
- Subject at high risk of the H5N1 infection during the trial.
- Thrombocytopenia or bleeding disorder contraindicating IM vaccination.
- Febrile illness (rectal equivalent temperature ≥ 38.0°C) on the day of inclusion.
- Children/Adolescents aged ≥ 2 years to < 18 years:
- Breast-feeding mothers.
- Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures (if applicable, depending on the subject's age).
- Infants/toddlers aged ≥ 6 months to < 2 years:
- History of seizures.
Trial locations and contacts
1 site in 1 country.
About this study
This is an open, randomized, multicenter clinical trial.
Objectives:
- To describe the safety profiles during the 21 days following each primary and booster injection.
- To describe the immune response 21 days after each primary and booster injection of each formulation.
- To describe the antibody persistence after the first vaccination
- Being tested
- A/H5N1 Inactivated, split-virion pandemic influenza vaccine, A/H5N1 Inactivated, split virion pandemic influenza vaccine
- Keywords
- Influenza A/H5N1 Virus, Influenza Pandemic, Orthomyxoviridae Infections
- 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
A/H5N1 Inactivated, split virion pandemic influenza vaccineBiological
0.5 mL, Intramuscular
A/H5N1 Inactivated, split virion pandemic influenza vaccineBiological
0.25 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1 | Experimental | Subjects aged 9 to 17 years Receives: Biological: A/H5N1 Inactivated, split-virion pandemic influenza vaccine |
| Study Group 2 | Experimental | Subjects aged 3 to 8 years Receives: Biological: A/H5N1 Inactivated, split virion pandemic influenza vaccine |
| Study Group 3 | Experimental | Subjects aged 6 to 35 months 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 describe safety following administration of A/H5N1 inactivated 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 posted27 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 240 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
- NCT00491985
- Sponsor's protocol ID
- GPA04
- Status last verified
- Jan 2014
- First submitted
- 26 Jun 2007
- Last updated
- 14 Jan 2014
- Results posted
- No
Publications
Chotpitayasunondh T, Thisyakorn U, Pancharoen C, Pepin S, Nougarede N. Safety, humoral and cell mediated immune responses to two formulations of an inactivated, split-virion influenza A/H5N1 vaccine in children. PLoS One. 2008;3(12):e4028. doi: 10.1371/journal.pone.0004028. Epub 2008 Dec 29.
PubMed 19112513
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 2 Formulations of an Intramuscular A/H5N1 Pandemic Influenza Vaccine in Children
- ClinicalTrials.gov ID
- NCT00491985
- Acronym / sponsor ID
- GPA04
- Keywords
- Influenza A/H5N1 Virus, Influenza Pandemic, Orthomyxoviridae Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 27 Jun 2007 (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 is an open, randomized, multicenter clinical trial.
Objectives:
- To describe the safety profiles during the 21 days following each primary and booster injection.
- To describe the immune response 21 days after each primary and booster injection of each formulation.
- To describe the antibody persistence after the first vaccination
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study Group 1 | Experimental | Biological: A/H5N1 Inactivated, split-virion pandemic influenza vaccineSubjects aged 9 to 17 years |
| Study Group 2 | Experimental | Biological: A/H5N1 Inactivated, split virion pandemic influenza vaccineSubjects aged 3 to 8 years |
| Study Group 3 | Experimental | Biological: A/H5N1 Inactivated, split virion pandemic influenza vaccineSubjects aged 6 to 35 months |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Able to attend all scheduled visits and to comply with all trial procedures.
- Aged ≥ 2 years to < 18 years on the day of inclusion.
- Informed Consent Form signed by one parent or another legal representative and by an independent witness if the parent/legal representative is illiterate.
- For a female, inability to bear a child or negative urine pregnancy test (as applicable).
- For a female of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination (as applicable).
Key exclusion criteria (20 listed)
- Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- 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.
- Systemic hypersensitivity to any of the vaccine components or history of life threatening reaction to the trial vaccine or a vaccine containing the same substances (egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and octoxinol 9).
- Chronic illness at a stage that could interfere with trial conduct or completion.
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 | Study Group 1 |
| A/H5N1 Inactivated, split virion pandemic influenza vaccine0.5 mL, Intramuscular | Biological | Study Group 2 |
| A/H5N1 Inactivated, split virion pandemic influenza vaccine0.25 mL, Intramuscular | Biological | Study Group 3 |
Primary outcome
To describe safety following administration of A/H5N1 inactivated 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.
- Derived from this study: PubMed 19112513Chotpitayasunondh T, Thisyakorn U, Pancharoen C, Pepin S, Nougarede N. Safety, humoral and cell mediated immune responses to two formulations of an inactivated, split-virion influenza A/H5N1 vaccine in children. PLoS One. 2008;3(12):e4028. doi: 10.1371/journal.pone.0004028. Epub 2008 Dec 29.
- 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
1 site 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 and A/H5N1 Inactivated, split virion pandemic influenza vaccine in people with Influenza and Orthomyxoviridae Infections, run by Sanofi Pasteur, a Sanofi Company at 1 site in Thailand.
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 12 inclusion and 20 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 1 site in Thailand. 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 describe safety following administration of A/H5N1 inactivated split virion pandemic influenza vaccine. (time frame: 21 Days post-vaccination). 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 NCT00491985, which also lists 1 linked publication.
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.