InfluenzaPhase 2NCT00889889
Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Adults Aged >= 18 and <= 64, Plus Revaccination
A Phase 2 study testing Cell-Derived Trivalent Subunit Influenza Vaccine in people with Influenza, run by Abbott Biologicals at 15 sites in United States.
Trial summary
Immunogenicity and safety of a cell-derived influenza vaccine in adults aged >= 18 and <= 64 years, plus revaccination Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Cell-Derived Trivalent Subunit Influenza Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,270 participants
- Where
- 15 sitesUnited States
- Study dates
- May 2009to Jan 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to give informed consent and able to adhere to all protocol required study procedures.
- Men and women aged >= 18 and <= 64 years.
- Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.
Who cannot join
- Known to be allergic to constituents of the vaccine.
- A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
- Having received vaccination against influenza or lab confirmed influenza within the previous six months before study vaccination.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Site Reference ID/Investigator# 45683
Austin, Texas, 78705
Site Reference ID/Investigator# 45695
Fort Worth, Texas, 76135
Site Reference ID/Investigator# 45690
Jacksonville, Florida, 32216
Site Reference ID/Investigator# 45684
Kansas City, Missouri, 64114
Site Reference ID/Investigator# 45686
Las Vegas, Nevada, 89104
Site Reference ID/Investigator# 45691
Lenexa, Kansas, 66219
Site Reference ID/Investigator# 45682
Lexington, Kentucky, 40509
Site Reference ID/Investigator# 45696
Nashville, Tennessee, 37203
Site Reference ID/Investigator# 45685
Omaha, Nebraska, 68134
Site Reference ID/Investigator# 45689
Overland Park, Kansas, 66212
Site Reference ID/Investigator# 45687
Pembroke Pines, Florida, 33024
Site Reference ID/Investigator# 45688
Raleigh, North Carolina, 27612
Site Reference ID/Investigator# 45692
Salt Lake City, Utah, 84124
Site Reference ID/Investigator# 45697
South Miami, Florida, 33143
Site Reference ID/Investigator# 45694
Wichita, Kansas, 67207
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of a Cell-Derived Trivalent Subunit Influenza Vaccine in Subjects Aged >= 18 Years and <= 64 Years During Two Consecutive Years.
Immunogenicity and safety of a cell-derived influenza vaccine in adults aged >= 18 and <= 64 years, plus revaccination
- Conditions
- Influenza
- Being tested
- Cell-Derived Trivalent Subunit Influenza Vaccine, Placebo
- Keywords
- Influenza, Phase II, Placebo-controlled
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell-Derived Trivalent Subunit Influenza VaccineBiological
surface antigen, inactivated, prepared in cell cultures
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: Cell-Derived Trivalent Subunit Influenza Vaccine |
| 2 | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the FDA requirement for influenza vaccines.
Measured: 3 weeks
To assess after the first vaccination the safety and tolerability of the cell-derived subunit vaccine compared to placebo.
Measured: 6 months
Secondary outcomes (3)
To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.
Measured: 6 months
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination.
Measured: 3 weeks
To assess after the second vaccination the safety and tolerability of the cell-derived subunit vaccine.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionJan 2011
- Study completionJan 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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Biologicals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Hanka de Voogd, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889889
- Sponsor's protocol ID
- S203.2.004
- Status last verified
- Sep 2013
- First submitted
- 28 Apr 2009
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of a Cell-Derived Trivalent Subunit Influenza Vaccine in Subjects Aged >= 18 Years and <= 64 Years During Two Consecutive Years.
- ClinicalTrials.gov ID
- NCT00889889
- Acronym / sponsor ID
- S203.2.004
- Conditions
- Influenza
- Keywords
- Influenza, Phase II, Placebo-controlled
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,270 participants (actual)
- Lead sponsor
- Abbott BiologicalsIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- May 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 29 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.
Immunogenicity and safety of a cell-derived influenza vaccine in adults aged >= 18 and <= 64 years, plus revaccination
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Cell-Derived Trivalent Subunit Influenza Vaccine |
| 2 | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Willing and able to give informed consent and able to adhere to all protocol required study procedures.
- Men and women aged >= 18 and <= 64 years.
- Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.
Key exclusion criteria (3 listed)
- Known to be allergic to constituents of the vaccine.
- A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
- Having received vaccination against influenza or lab confirmed influenza within the previous six months before study 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 |
|---|---|---|
| Cell-Derived Trivalent Subunit Influenza Vaccinesurface antigen, inactivated, prepared in cell cultures | Biological | 1 |
| PlaceboPlacebo | Biological | 2 |
Primary outcome
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the FDA requirement for influenza vaccines.
Time frame: 3 weeks
To assess after the first vaccination the safety and tolerability of the cell-derived subunit vaccine compared to placebo.
Time frame: 6 months
3 secondary outcomes
To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.
Time frame: 6 months
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination.
Time frame: 3 weeks
To assess after the second vaccination the safety and tolerability of the cell-derived subunit vaccine.
Time frame: 6 months
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 25 Oct 2013.
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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.
Hanka de Voogd, MD study director
Abbott
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 Cell-Derived Trivalent Subunit Influenza Vaccine in people with Influenza, run by Abbott Biologicals at 15 sites in United States.
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 3 inclusion and 3 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 25 Oct 2013. 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 United States. 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. Some participants in this study may receive a placebo. 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 assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the FDA requirement for influenza vaccines. (time frame: 3 weeks). 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 25 Oct 2013.