InfluenzaPhase 1/2NCT00959465
A/H1N1 Immunogenicity and Safety in Adults
A Phase 1/2 study testing H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated) in people with Influenza and Pandemic Influenza, run by Alachua Government Services, Inc. at 5 sites in 2 countries.
Trial summary
The purpose of the study is to obtain immunogenicity and safety data at different dose levels of an investigational H1N1 pandemic influenza vaccine in healthy adults 18 years of age and older. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Pandemic Influenza
- What is being tested?
- H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Aug 2009to Apr 2010
- Phase
- Phase 1/2
- 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
- Subject is 18 to 59 years old (age stratum A) or 60 years of age or older (age stratum B) at the time of screening
- Subject has an understanding of the study, agrees to its provisions, and gives written informed consent prior to study entry
- Subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and the performance of a physical examination
- Subject is physically and mentally capable of participating in the study and willing to adhere to study procedures to include completion of all elements of the study diary
- If female of childbearing potential, subject has a negative urine pregnancy test result within 24 hours prior to the scheduled first vaccination and agrees to employ adequate birth control measures for the duration of the study
Who cannot join
- Subject has participated in another clinical study involving an investigational drug, biological product or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an investigational drug, biological or device during the course of this study
- Subject has a history of exposure to A/H1N1/California/07/2009 virus or a history of vaccination with A/H1N1/California/07/2009 antigen or a closely related influenza virus antigen
- Subject has inherited or acquired immune deficiency
- Subject currently has or has a recent history of significant neurological, cardiovascular or pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Austria4 sites
Sanatorium Leech
Graz, 8010
ClinPharm International GmbH
Vienna, 1090
Medical University of Vienna, Institute for Specific Prophylaxis and Tropical Medicine
Vienna, 1090
University Hospital, Department of Clinical Pharmacology
Vienna, 1090
About this study
Official title: An Open Label Phase 1/2 Study to Assess Immunogenicity and Safety of Different Dose Levels of H1N1 Pandemic Influenza Vaccine in Healthy Adults Aged 18 Years and Older
The purpose of the study is to obtain immunogenicity and safety data at different dose levels of an investigational H1N1 pandemic influenza vaccine in healthy adults 18 years of age and older.
- Conditions
- Influenza, Pandemic Influenza
- Being tested
- H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)Biological
Two injections at a 21-day interval (Days 1 and 22)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1/Dose Level A | Experimental | Subjects in Cohort 1 will be randomized 1:1 to receive two vaccinations of Dose A or Dose B of H1N1 pandemic influenza vaccine at a 21-day interval. Receives: Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated) |
| Cohort 1/Dose B | Experimental | Subjects in Cohort 1 will be randomized 1:1 to receive two vaccinations of Dose A or Dose B of H1N1 pandemic influenza vaccine at a 21-day interval. Receives: Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated) |
| Cohort 2/Dose C | Experimental | A second cohort may be enrolled with all subjects in this cohort receiving two vaccinations of Dose C of H1N1 pandemic influenza vaccine at a 21-day interval. Receives: Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects achieving antibody levels to A/H1N1/California/07/2009 virus that meet the definition of seroprotection and seroconversion at 21 days after the second vaccination
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionNov 2009
- Study completionApr 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.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alachua Government Services, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gerald Aichinger, MD, Study director, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959465
- Sponsor's protocol ID
- 820902
- Other IDs
- EUDRACT Number 2009-013394-17
- Status last verified
- Jul 2010
- First submitted
- 13 Aug 2009
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase 1/2 Study to Assess Immunogenicity and Safety of Different Dose Levels of H1N1 Pandemic Influenza Vaccine in Healthy Adults Aged 18 Years and Older
- ClinicalTrials.gov ID
- NCT00959465
- Acronym / sponsor ID
- 820902
- Conditions
- Influenza, Pandemic Influenza
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Alachua Government Services, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 14 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 the study is to obtain immunogenicity and safety data at different dose levels of an investigational H1N1 pandemic influenza vaccine in healthy adults 18 years of age and older.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1/Dose Level A | Experimental | Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)Subjects in Cohort 1 will be randomized 1:1 to receive two vaccinations of Dose A or Dose B of H1N1 pandemic influenza vaccine at a 21-day interval. |
| Cohort 1/Dose B | Experimental | Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)Subjects in Cohort 1 will be randomized 1:1 to receive two vaccinations of Dose A or Dose B of H1N1 pandemic influenza vaccine at a 21-day interval. |
| Cohort 2/Dose C | Experimental | Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)A second cohort may be enrolled with all subjects in this cohort receiving two vaccinations of Dose C of H1N1 pandemic influenza vaccine at a 21-day interval. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is 18 to 59 years old (age stratum A) or 60 years of age or older (age stratum B) at the time of screening
- Subject has an understanding of the study, agrees to its provisions, and gives written informed consent prior to study entry
- Subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and the performance of a physical examination
- Subject is physically and mentally capable of participating in the study and willing to adhere to study procedures to include completion of all elements of the study diary
- If female of childbearing potential, subject has a negative urine pregnancy test result within 24 hours prior to the scheduled first vaccination and agrees to employ adequate birth control measures for the duration of the study
Key exclusion criteria (4 listed)
- Subject has participated in another clinical study involving an investigational drug, biological product or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an investigational drug, biological or device during the course of this study
- Subject has a history of exposure to A/H1N1/California/07/2009 virus or a history of vaccination with A/H1N1/California/07/2009 antigen or a closely related influenza virus antigen
- Subject has inherited or acquired immune deficiency
- Subject currently has or has a recent history of significant neurological, cardiovascular or pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
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 |
|---|---|---|
| H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)Two injections at a 21-day interval (Days 1 and 22) | Biological | Cohort 1/Dose B, Cohort 1/Dose Level A, Cohort 2/Dose C |
Primary outcome
Number of subjects achieving antibody levels to A/H1N1/California/07/2009 virus that meet the definition of seroprotection and seroconversion at 21 days after the second vaccination
Time frame: 42 days
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 9 Oct 2015.
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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.
Gerald Aichinger, MD study director
Baxter Healthcare Corporation
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated) in people with Influenza and Pandemic Influenza, run by Alachua Government Services, Inc. at 5 sites in 2 countries.
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 5 inclusion and 4 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 9 Oct 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 Austria, Germany. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of subjects achieving antibody levels to A/H1N1/California/07/2009 virus that meet the definition of seroprotection and seroconversion at 21 days after the second vaccination (time frame: 42 days). 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 9 Oct 2015.