InfluenzaPhase 3NCT00999206
Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza Vaccine
A Phase 3 study testing Influenza Vaccine in people with Influenza, run by Abbott Biologicals at 19 sites in 2 countries.
Trial summary
A phase 3 study to obtain additional safety and immunogenicity data on Solvay's cell-derived seasonal trivalent subunit influenza vaccine in adult and elderly subjects without significant illnesses and to demonstrate consistency of the immunogenicity of the three lots of the same vaccine, comparison of cell-derived… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,138 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Jan 2010to Aug 2010
- Phase
- Phase 3
- 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
- Female or male subjects >= 18 years of age (adults >= 18 to < =60 years of age or elderly >= 61 years of age).
- Willing and able to give informed consent before any protocol procedures are performed.
- Able to adhere to visit schedules and all protocol required study procedures.
- Being in good health as determined by medical history, physical examination and clinical judgment of the investigator (subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as the disease is well controlled. If on medication for a condition, the medication dose must have been stable for at least 3 months preceding study vaccination).
Who cannot join
- Influenza vaccination or laboratory confirmed influenza infection within six months preceding the date of study vaccination or planning an influenza vaccination during the three weeks after study vaccination (i.e. between study Day 1 and study Day 22).
- Presence of any significant condition that may prohibit inclusion as determined by the Investigator.
- A serious adverse reaction after a previous (influenza) vaccination.
- A history of Guillain-Barré syndrome.
- Known to be allergic to constituents of the study vaccines.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
Australia13 sites
Site Reference ID/Investigator# 44652
Adelaide, 5000
Site Reference ID/Investigator# 44662
Auchenflower, 4066
Site Reference ID/Investigator# 44651
Blacktown, 2148
Site Reference ID/Investigator# 44659
Blacktown, 2148
Site Reference ID/Investigator# 44647
Broadmeadow, 2292
Site Reference ID/Investigator# 44649
Caboolture, 4510
Site Reference ID/Investigator# 44646
Carina Heights, 4152
Site Reference ID/Investigator# 44650
Herston, 4006
Site Reference ID/Investigator# 44663
Hornsby, 2077
Site Reference ID/Investigator# 44645
Kippa-Ring, 4020
Site Reference ID/Investigator# 44644
Malvern East, 3145
Site Reference ID/Investigator# 44648
Maroubra Junction, 2035
Site Reference ID/Investigator# 44643
Sherwood, 4075
New Zealand6 sites
Site Reference ID/Investigator# 44653
Christchurch
Site Reference ID/Investigator# 44658
Dunedin, 9012
Site Reference ID/Investigator# 44656
Grafton, 1150
Site Reference ID/Investigator# 44655
Rotorua, 3010
Site Reference ID/Investigator# 44654
Tauranga, 3110
Site Reference ID/Investigator# 44657
Wellington, 6035
About this study
Official title: Randomized, Double-Blind Study to Assess Safety, Immunogenicity, and Lot Consistency of Solvay's Cell-Derived Influenza Vaccine and Its Non-Inferiority Compared to Influvac®.
A phase 3 study to obtain additional safety and immunogenicity data on Solvay's cell-derived seasonal trivalent subunit influenza vaccine in adult and elderly subjects without significant illnesses and to demonstrate consistency of the immunogenicity of the three lots of the same vaccine, comparison of cell-derived vaccine to Solvay's egg-derived vaccine including assessment of non-inferior immunogenicity
- Conditions
- Influenza
- Being tested
- Influenza Vaccine
- Keywords
- Influenza, Vaccine, CHMP criteria
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza VaccineBiological
surface antigen, inactivated, prepared in cell cultures
Influenza VaccineBiological
surface antigen, inactivated, prepared in egg (influvac ®)
Influenza VaccineBiological
surface antigen, inactivated, prepared in cell cultures
Influenza VaccineBiological
surface antigen, inactivated, prepared in cell cultures
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: Influenza Vaccine |
| 2 | Experimental | Not described Receives: Biological: Influenza Vaccine |
| 3 | Experimental | Not described Receives: Biological: Influenza Vaccine |
| 4 | Active comparator | Not described Receives: Biological: Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-HA antibody titers and derived parameters seroprotection, seroconversion and fold increase
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startJan 2010
- Primary completionAug 2010
- Study completionAug 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3,138 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 Healthcare Products B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999206
- Sponsor's protocol ID
- S203.3.013
- Status last verified
- Aug 2011
- First submitted
- 20 Oct 2009
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind Study to Assess Safety, Immunogenicity, and Lot Consistency of Solvay's Cell-Derived Influenza Vaccine and Its Non-Inferiority Compared to Influvac®.
- ClinicalTrials.gov ID
- NCT00999206
- Acronym / sponsor ID
- S203.3.013
- Conditions
- Influenza
- Keywords
- Influenza, Vaccine, CHMP criteria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,138 participants (actual)
- Lead sponsor
- Abbott BiologicalsIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 Oct 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.
A phase 3 study to obtain additional safety and immunogenicity data on Solvay's cell-derived seasonal trivalent subunit influenza vaccine in adult and elderly subjects without significant illnesses and to demonstrate consistency of the immunogenicity of the three lots of the same vaccine, comparison of cell-derived vaccine to Solvay's egg-derived vaccine including assessment of non-inferior immunogenicity
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Influenza Vaccine |
| 2 | Experimental | Biological: Influenza Vaccine |
| 3 | Experimental | Biological: Influenza Vaccine |
| 4 | Active comparator | Biological: Influenza Vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female or male subjects >= 18 years of age (adults >= 18 to < =60 years of age or elderly >= 61 years of age).
- Willing and able to give informed consent before any protocol procedures are performed.
- Able to adhere to visit schedules and all protocol required study procedures.
- Being in good health as determined by medical history, physical examination and clinical judgment of the investigator (subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as the disease is well controlled. If on medication for a condition, the medication dose must have been stable for at least 3 months preceding study vaccination).
Key exclusion criteria (5 listed)
- Influenza vaccination or laboratory confirmed influenza infection within six months preceding the date of study vaccination or planning an influenza vaccination during the three weeks after study vaccination (i.e. between study Day 1 and study Day 22).
- Presence of any significant condition that may prohibit inclusion as determined by the Investigator.
- A serious adverse reaction after a previous (influenza) vaccination.
- A history of Guillain-Barré syndrome.
- Known to be allergic to constituents of the study vaccines.
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 |
|---|---|---|
| Influenza Vaccinesurface antigen, inactivated, prepared in cell cultures | Biological | 3 |
| Influenza Vaccinesurface antigen, inactivated, prepared in egg (influvac ®) | Biological | 4 |
| Influenza Vaccinesurface antigen, inactivated, prepared in cell cultures | Biological | 1 |
| Influenza Vaccinesurface antigen, inactivated, prepared in cell cultures | Biological | 2 |
Primary outcome
Anti-HA antibody titers and derived parameters seroprotection, seroconversion and fold increase
Time frame: 3 weeks
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 26 Aug 2011.
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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 Healthcare Products B.V.
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Influenza Vaccine in people with Influenza, run by Abbott Biologicals at 19 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 4 inclusion and 5 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 26 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Australia, New Zealand. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Anti-HA antibody titers and derived parameters seroprotection, seroconversion and fold increase (time frame: 3 weeks). 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 26 Aug 2011.